A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Candidate Vaccine (GSK2321138A) Manufactured Using a New Process in Adults and Children
Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT02207413
Collaborator
(none)
1,886
53
6
8
35.6
4.5
Study Details
Study Description
Brief Summary
The purpose of this trial is to demonstrate the acceptable safety profile and the immunological non-inferiority of the FLU D-QIV vaccine manufactured with this investigational process (FLU D-QIV Investigational Process [IP]) compared to FLU D-QIV manufactured with the current licensed process (FLU D-QIV Licensed Process [LP]).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
This study will enroll 3 age cohorts:
Adults: 18-49 years, Children: 3-17 years and 6-35 months of age.
Study Design
Study Type:
Interventional
Actual Enrollment
:
1886 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Safety and Immunogenicity Study of GSK Biologicals' Quadrivalent Influenza Candidate Vaccine (GSK23211381A) Manufactured With a New Process in Adults and Children
Study Start Date
:
Aug 18, 2014
Actual Primary Completion Date
:
Apr 18, 2015
Actual Study Completion Date
:
Apr 18, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Influsplit Tetra_IP Adult Group Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm. |
Biological: Influsplit Tetra™ vaccine produced by investigational process (IP)
Influsplit Tetra™ vaccine using a new manufacturing process administered intramuscularly (IM) in the deltoid region of non-dominant arm (Dose 1) in Adults Group and in non-dominant deltoid or left anterolateral thigh (Dose 1) and dominant deltoid or right anterolateral (Dose 2 - unprimed subjects) in 6-35m and 3-17y Groups.
Other Names:
|
| Active Comparator: Influsplit Tetra_LP Adult Group Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm. |
Biological: Influsplit Tetra™ vaccine produced by licensed process (LP)
Influsplit Tetra™ vaccine using a licensed manufacturing process administered IM in the deltoid region of non-dominant arm (Dose 1) in Adults Group and in non-dominant deltoid or left anterolateral thigh (Dose 1) and dominant deltoid or right anterolateral (Dose 2 - unprimed subjects) in 6-35m and 3-17y Groups.
Other Names:
|
| Experimental: Influsplit Tetra_IP 3-17y Group Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28). |
Biological: Influsplit Tetra™ vaccine produced by investigational process (IP)
Influsplit Tetra™ vaccine using a new manufacturing process administered intramuscularly (IM) in the deltoid region of non-dominant arm (Dose 1) in Adults Group and in non-dominant deltoid or left anterolateral thigh (Dose 1) and dominant deltoid or right anterolateral (Dose 2 - unprimed subjects) in 6-35m and 3-17y Groups.
Other Names:
|
| Active Comparator: Influsplit Tetra_LP 3-17y Group Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28). |
Biological: Influsplit Tetra™ vaccine produced by licensed process (LP)
Influsplit Tetra™ vaccine using a licensed manufacturing process administered IM in the deltoid region of non-dominant arm (Dose 1) in Adults Group and in non-dominant deltoid or left anterolateral thigh (Dose 1) and dominant deltoid or right anterolateral (Dose 2 - unprimed subjects) in 6-35m and 3-17y Groups.
Other Names:
|
| Experimental: Influsplit Tetra_IP 6-35m Group Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28). |
Biological: Influsplit Tetra™ vaccine produced by investigational process (IP)
Influsplit Tetra™ vaccine using a new manufacturing process administered intramuscularly (IM) in the deltoid region of non-dominant arm (Dose 1) in Adults Group and in non-dominant deltoid or left anterolateral thigh (Dose 1) and dominant deltoid or right anterolateral (Dose 2 - unprimed subjects) in 6-35m and 3-17y Groups.
Other Names:
|
| Active Comparator: Influsplit Tetra_LP 6-35m Group Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28). |
Biological: Influsplit Tetra™ vaccine produced by licensed process (LP)
Influsplit Tetra™ vaccine using a licensed manufacturing process administered IM in the deltoid region of non-dominant arm (Dose 1) in Adults Group and in non-dominant deltoid or left anterolateral thigh (Dose 1) and dominant deltoid or right anterolateral (Dose 2 - unprimed subjects) in 6-35m and 3-17y Groups.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Subjects Aged 18-49 Years Reporting Solicited Local Adverse Events (AEs). [During the 7-day (Days 0-6) post-vaccination period]
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = significant pain at rest and pain that prevented normal everyday activities. Grade 3 redness and swelling = greater than 100 millimeters (mm) i.e. >100mm.
- Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. [During the 7-day (Days 0-6) post-vaccination period]
Solicited general symptoms assessed were fatigue,gastrointestinal symptoms, headache, Joint Pain, myalgia, shivering and fever. Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Grade 3 was defined as symptoms that prevented normal activities. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Any fever was defined as subjects with a documented temperature of greater than or equal to (≥) 38°C/100.4°F by any route and all subjects reporting temperature less than (< )38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever was defined as temperature ≥39.0°C.
- Duration of Solicited Local and General AEs in Subjects Aged 18-49 Years. [During the 7-day (Days 0-6) post-vaccination period]
Duration was defined as number of days with any grade of local and general symptoms.
- Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. [During the 3-day (Days 0-2) post-vaccination period]
Oculorespiratory syndrome (ORS) was defined as the occurrence within 24 hours after vaccination of one or more of the following newly onset symptoms: bilateral red eyes, cough, wheeze, chest tightness, difficulty breathing, difficulty swallowing, hoarseness, sore throat, facial swelling. Any was defined as any ORS symptom regardless of intensity grade or relationship to vaccination. Grade 3 ORS was defined as ORS symptoms that prevented normal activities. Related ORS was defined as ORS symptom(s) assessed by the investigator as causally related to the vaccination.
- Number of Subjects Aged 18-49 Years Reporting the Occurrence of Medically Attended Events (MAEs). [During the entire study period (approximately 21 days following vaccination)]
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s). Grade 3 was defined as MAE that prevented normal activities. Related was defined as MAE assessed by the investigator to be causally related to the study vaccination.
- Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). [During the 7-day (Days 0-6) post-vaccination period]
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling = greater than 50 millimeters (mm) i.e. >50mm.
- Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. [During the 7-day (Days 0-6) post-vaccination period]
Solicited general symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity. Any fever was defined as subjects with a documented temperature of greater than or equal to (≥) 38°C/100.4°F by any route and all subjects reporting temperature less than (< )38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever was defined as temperature greater than (>) 39.0°C.
- Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. [During the 7-day (Days 0-6) post-vaccination period]
Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, joint pain, myalgia, shivering and fever (Fever = temperature above 38.0 degrees Celsius (°C)). Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Any fever = all subjects with a documented temperature of ≥ 38°C/100.4°F by any route and all subjects reporting temperature < 38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever = temperature above 39.0°C.
- Duration of Solicited Local AEs in Subjects Aged 3-17 Years. [During the 7-day (Days 0-6) post-vaccination period]
Duration was defined as number of days with any grade of local symptoms.
- Duration of Solicited General AEs in Subjects Aged 3-4 Years. [During the 7-day (Days 0-6) post-vaccination period]
Duration was defined as number of days with any grade of general symptoms.
- Duration of Solicited General AEs in Subjects Aged 5-17 Years. [During the 7-day (Days 0-6) post-vaccination period]
Duration was defined as number of days with any grade of general symptoms.
- Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. [During the 3-day (Days 0-2) post-vaccination period]
Oculorespiratory syndrome (ORS) was defined as the occurrence within 24 hours after vaccination of one or more of the following newly onset symptoms: bilateral red eyes, cough, wheeze, chest tightness, difficulty breathing, difficulty swallowing, hoarseness, sore throat, facial swelling. Any = occurrence of any ORS symptom regardless of intensity grade or relationship to vaccination. Grade 3 = ORS symptoms that prevented normal activities. Related = ORS symptom assessed by the investigator as causally related to the vaccination.
- Number of Subjects Aged 3-17 Years Reporting the Occurrence of All Medically Attended Events (MAEs) . [During the entire study period (approximately 28 days (primed subjects) and 56 days (unprimed subjects) following vaccination]
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s). Grade 3 was a MAE that prevented normal activities. Related was defined as a MAE assessed by the investigator to be causally related to the study vaccination.
- Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [During the 21-day (Days 0-20) follow-up period after vaccination]
An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
- Number of Subjects Aged 3-17 Years Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). [During the 28-day (Days 0-27) follow-up period after vaccination]
An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
- Number of Subjects Aged 6-35 Months Reporting Fever ≥38ºC Across Doses. [During 7 days (Days 0-6) post-vaccination]
Any fever = all subjects with a documented temperature of ≥ 38°C/100.4°F by any route and all subjects reporting temperature < 38°C but with missing values (MC) for at least one day during the solicited period.
- Number of Subjects Aged 18-49 Years, Reporting Any and Related Serious Adverse Events (SAEs) [During the entire study period (approximately 21 days)]
A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
- Number of Subjects Aged 3-17 Years, Reporting Any and Related Serious Adverse Events (SAEs) [During the entire study period [approximately 28 days (primed subjects) and 56 days (unprimed subjects)]]
A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
- Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. [At Day 28 post last vaccination]
HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), FluA/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
- Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. [At Day 28 post last vaccination]
HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), FluA/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Secondary Outcome Measures
- Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 18-49 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains [At Day 0 and Day 21]
HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
- Number of Seroconverted Subjects Aged 18-49 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. [At Day 21]
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
- Number of Subjects Aged 18-49 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. [At Day 0 and Day 21]
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
- Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 18-49 Years. [At Day 21]
MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
- Number of Subjects Aged 5-17 Years Reporting Myalgia Across Doses. [During the 7-day (Days 0-6) post-vaccination period]
Any = occurrence of any myalgia symptom regardless of intensity grade or relationship to vaccination.
- Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains [At Day 0 and Day 28 post last vaccination]
HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
- Number of Seroconverted Subjects Aged 3-17 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. [At Day 28 post last vaccination]
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
- Number of Subjects Aged 3-17 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. [At Day 0 and Day 28 post last vaccination]
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
- Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 3-17 Years. [At Day 28 post last vaccination]
MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
- Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains [At Day 0 and Day 28 post last vaccination]
HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
- Number of Seroconverted Subjects Aged 6-35 Months for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. [At Day 28 post last vaccination]
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
- Number of Subjects Aged 6-35 Months, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. [At Day 0 and Day 28 post last vaccination]
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
- Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 6-35 Months. [At Day 28 post last vaccination]
MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
- Number of Subjects Aged 6-35 Months Reporting Fever ≥38ºC After Dose 1 and After Dose 2. [During 7 days (Days 0-6) post-vaccination]
Any fever = all subjects with a documented temperature of ≥ 38°C/100.4°F by any route and all subjects reporting temperature < 38°C but with missing values (MC) for at least one day during the solicited period. Fever = temperature of ≥ 38°C/100.4°F by any route
- Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). [During the 7-day (Days 0-6) post-vaccination period]
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = significant pain at rest and pain that prevented normal everyday activities. Grade 3 redness and swelling = greater than 50 millimeters (mm) i.e. > 50mm.
- Number of Subjects Aged 6 Months to <5 Years, Reporting Fever ≥38ºC (100.4°F) and >39.0°C (102.2ºF) Across Doses. [During the 2 days (Day 0-Day 1) post-vaccination period]
Any fever = all subjects with a documented temperature of ≥ 38°C/100.4°F by any route and all subjects reporting temperature < 38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever = temperature above 39.0°C/102.2ºF. Data of 2 independent groups were pooled.
- Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. [During the 7-day (Days 0-6) post-vaccination period]
Solicited general symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity. Any fever was defined as subjects with a documented temperature of greater than or equal to (≥) 38°C/100.4°F by any route and all subjects reporting temperature less than (< )38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever was defined as temperature greater than (>)39.0°C.
- Duration of Solicited Local AEs in Subjects Aged 6-35 Months. [During the 7-day (Days 0-6) post-vaccination period]
Duration was defined as number of days with any grade of local symptoms.
- Duration of Solicited General AEs in Subjects Aged 6-35 Months. [During the 7-day (Days 0-6) post-vaccination period]
Duration was defined as number of days with any grade of general symptoms.
- Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. [During a 3 day (Days 0-2) follow-up period after vaccination]
Oculorespiratory syndrome (ORS) was defined as the occurrence within 24 hours after vaccination of one or more of the following newly onset symptoms: bilateral red eyes, cough, wheeze, chest tightness, difficulty breathing, difficulty swallowing, hoarseness, sore throat, facial swelling. Any = occurrence of any ORS symptom regardless of intensity grade or relationship to vaccination. Grade 3 = ORS symptoms that prevented normal activities. Related = ORS symptom assessed by the investigator as causally related to the vaccination.
- Number of Subjects Aged 6-35 Months Reporting the Occurrence of All Medically Attended Events (MAEs) [During the entire study period (approximately 28 days (primed subjects) and 56 days (unprimed subjects) following vaccination]
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s). Grade 3 was a MAE that prevented normal activities. Related was defined as a MAE assessed by the investigator to be causally related to the study vaccination.
- Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). [During the 28-day (Days 0-27) follow-up period after vaccination]
An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 unsolicited AE was defined as an event that prevented normal activity. Related unsolicited AE was defined as an event assessed by the investigator to be causally related to the study vaccination.
- Number of Subjects Aged 6-35 Months, Reporting Any and Related Serious Adverse Events (SAEs) [During the entire study period [approximately 28 days (primed subjects) and 56 days (unprimed subjects)]]
A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Eligibility Criteria
Criteria
Ages Eligible for Study:
6 Months
to 49 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
Adults 18-49 years cohort:
-
A male or female between, and including, 18 and 49 years of age at the time of vaccination.
-
Subjects who the investigator believes that they/their parent(s)/Legally Acceptable Representatives (LAR(s)) can and will comply with the requirements of the protocol.
-
Written informed consent obtained from the subject/parent(s)/LAR(s) of the subject.
-
Written informed assent obtained from the subject if/as required by local regulations.
-
Healthy subjects or those with chronic well-controlled disease as established by medical history and clinical examination before entering into the study.
-
Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy.
-
Female subjects of childbearing potential may be enrolled in the study, if the subject: has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception for 2 months after vaccination.
Pediatric cohort:
United States:
• A male or female subject between, and including, the ages of 3 and 17 years in the United States.
Rest of the World:
• A male or female subject between, and including, the ages of 6 months to 17 years all countries with the exception of the United States.
All participating countries:
-
Subjects who the investigator believes that they/their parent(s)/Legally Acceptable Representatives (LAR(s)) can and will comply with the requirements of the protocol.
-
Written informed consent obtained from the subject/parent(s)/LAR(s) of the subject.
-
Written informed assent obtained from the subject if/as required by local regulations.
-
Healthy subjects or those with chronic well-controlled disease as established by medical history and clinical examination before entering into the study.
-
Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy.
-
Female subjects of childbearing potential may be enrolled in the study, if the subject: has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Exclusion Criteria:
Adults aged 18-49 years cohort:
-
Child in care.
-
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
-
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical or device).
-
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose. Inhaled and topical steroids are allowed.
-
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
-
Any administration of a long-acting immune-modifying drug within 6 months before study start, or planned administration during the study period.
-
Administration of an influenza vaccine during the 6 months preceding entry into the study.
-
Administration of a vaccine not foreseen by the study protocol within 30 days before vaccination or planned administration during the study period.
-
Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
-
Any known or suspected allergy to any constituent of influenza vaccines (including egg proteins); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
-
Acute or un-controlled, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests.
-
Any history of Guillain-Barré Syndrome.
-
Acute disease and/or fever at the time of enrolment. Fever is defined as temperature ≥ 38.0ºC/100.4ºF.
-
Pregnant or lactating female.
-
Female planning to become pregnant or planning to discontinue contraceptive precautions.
-
History of chronic alcohol consumption and/or drug abuse.
-
Any contra-indication to intramuscular administration of influenza vaccines.
-
Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.
Pediatric cohort
-
Child in care.
-
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
-
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical or device).
-
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccination dose. Inhaled and topical steroids are allowed.
-
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
-
Any administration of a long-acting immune-modifying drug within 6 months before study start, or planned administration during the study period.
-
Administration of an influenza vaccine during the 6 months preceding entry into the study.
-
Administration of a vaccine not foreseen by the study protocol within 30 days before vaccination or planned administration during the study period.
-
Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
-
Any known or suspected allergy to any constituent of influenza vaccines (including egg proteins); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
-
Acute or un-controlled, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests.
-
Any history of Guillain-Barré Syndrome.
-
Acute disease and/or fever at the time of enrolment. Fever is defined as temperature ≥ 38.0ºC/100.4ºF.
-
Pregnant or lactating female.
-
Female planning to become pregnant or planning to discontinue contraceptive precautions.
-
History of chronic alcohol consumption and/or drug abuse.
-
Any contra-indication to intramuscular administration of influenza vaccines.
-
Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GSK Investigational Site | Wichita | Kansas | United States | 67207 |
| 2 | GSK Investigational Site | Rochester | New York | United States | 14609 |
| 3 | GSK Investigational Site | Warwick | Rhode Island | United States | 02886 |
| 4 | GSK Investigational Site | Nashville | Tennessee | United States | 37203 |
| 5 | GSK Investigational Site | Dhaka | Bangladesh | 1000 | |
| 6 | GSK Investigational Site | Brno | Czechia | 613 00 | |
| 7 | GSK Investigational Site | Chlumec nad Cidlinou | Czechia | 50351 | |
| 8 | GSK Investigational Site | Decin | Czechia | 405 01 | |
| 9 | GSK Investigational Site | Jindrichuv Hradec | Czechia | 37701 | |
| 10 | GSK Investigational Site | Liberec | Czechia | ||
| 11 | GSK Investigational Site | Lipnik nad Becvou | Czechia | 75131 | |
| 12 | GSK Investigational Site | Nachod | Czechia | 547 01 | |
| 13 | GSK Investigational Site | Odolena voda | Czechia | 25070 | |
| 14 | GSK Investigational Site | Ostrava - Poruba | Czechia | 70800 | |
| 15 | GSK Investigational Site | Pardubice | Czechia | 532 03 | |
| 16 | GSK Investigational Site | Praha 6 | Czechia | 1600 | |
| 17 | GSK Investigational Site | Aix en Provence | France | 13100 | |
| 18 | GSK Investigational Site | Dax | France | 40100 | |
| 19 | GSK Investigational Site | Draguignan | France | 83300 | |
| 20 | GSK Investigational Site | Essey les Nancy | France | 54270 | |
| 21 | GSK Investigational Site | Le Havre | France | 76620 | |
| 22 | GSK Investigational Site | Nantes cedex 2 | France | 44277 | |
| 23 | GSK Investigational Site | Nice | France | 06300 | |
| 24 | GSK Investigational Site | Kehl | Baden-Wuerttemberg | Germany | 77694 |
| 25 | GSK Investigational Site | Stuttgart | Baden-Wuerttemberg | Germany | 70469 |
| 26 | GSK Investigational Site | Kirchheim | Bayern | Germany | 85551 |
| 27 | GSK Investigational Site | Schoenau Am Koenigssee | Bayern | Germany | 83471 |
| 28 | GSK Investigational Site | Wuerzburg | Bayern | Germany | 97070 |
| 29 | GSK Investigational Site | Detmold | Nordrhein-Westfalen | Germany | 32756 |
| 30 | GSK Investigational Site | Essen | Nordrhein-Westfalen | Germany | 45355 |
| 31 | GSK Investigational Site | Essen | Nordrhein-Westfalen | Germany | 45359 |
| 32 | GSK Investigational Site | Goch | Nordrhein-Westfalen | Germany | 47574 |
| 33 | GSK Investigational Site | Kleve-Materborn | Nordrhein-Westfalen | Germany | 47533 |
| 34 | GSK Investigational Site | Loehne | Nordrhein-Westfalen | Germany | 32584 |
| 35 | GSK Investigational Site | Trier | Rheinland-Pfalz | Germany | 54290 |
| 36 | GSK Investigational Site | Leipzig | Sachsen | Germany | 04178 |
| 37 | GSK Investigational Site | Radebeul | Sachsen | Germany | 01445 |
| 38 | GSK Investigational Site | Wurzen | Sachsen | Germany | 04808 |
| 39 | GSK Investigational Site | Flensburg | Schleswig-Holstein | Germany | 24937 |
| 40 | GSK Investigational Site | Berlin | Germany | 13055 | |
| 41 | GSK Investigational Site | Neumuenster | Germany | 24534 | |
| 42 | GSK Investigational Site | Bydgoszcz | Poland | 85-168 | |
| 43 | GSK Investigational Site | Debica | Poland | 39-200 | |
| 44 | GSK Investigational Site | Katowice | Poland | 40-018 | |
| 45 | GSK Investigational Site | Poznan | Poland | 62-064 | |
| 46 | GSK Investigational Site | Siemianowice Slaskie | Poland | 41-103 | |
| 47 | GSK Investigational Site | Wroclaw | Poland | 54-019 | |
| 48 | GSK Investigational Site | Antequera/Málaga | Spain | 29200 | |
| 49 | GSK Investigational Site | Badalona | Spain | 08916 | |
| 50 | GSK Investigational Site | Burgos | Spain | 09006 | |
| 51 | GSK Investigational Site | Madrid | Spain | 28050 | |
| 52 | GSK Investigational Site | Santiago de Compostela | Spain | 15706 | |
| 53 | GSK Investigational Site | Sevilla | Spain | 41014 |
Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT02207413
Other Study ID Numbers:
- 201251
First Posted:
Aug 4, 2014
Last Update Posted:
Jun 6, 2018
Last Verified:
May 1, 2018
Keywords provided by GlaxoSmithKline
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Primed subjects: Received 2 doses of seasonal influenza vaccine separated by at least one month during the last season or had received at least 1 dose prior to last season. Unprimed subjects: Did not receive any seasonal influenza vaccine in the past or received only 1 dose for the first time in the last influenza season. |
|---|---|
| Pre-assignment Detail | For 5 subjects, study vaccine dose not administered at all but subject number was allocated. Some data has been analysed in sub-groups by age: 3-4 years, 5-17 years, 6 months to <5 years. |
| Arm/Group Title | Influsplit Tetra_IP Adult Group | Influsplit Tetra_LP Adult Group | Influsplit Tetra_IP 3-17y Group | Influsplit Tetra_LP 3-17y Group | Influsplit Tetra_IP 6-35m Group | Influsplit Tetra_LP 6-35m Group |
|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm. | Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm. | Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28). | Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28). | Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28). | Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28). |
| Period Title: Overall Study | ||||||
| STARTED | 60 | 60 | 410 | 411 | 466 | 474 |
| COMPLETED | 59 | 60 | 410 | 410 | 459 | 461 |
| NOT COMPLETED | 1 | 0 | 0 | 1 | 7 | 13 |
Baseline Characteristics
| Arm/Group Title | Influsplit Tetra_IP Adult Group | Influsplit Tetra_LP Adult Group | Influsplit Tetra_IP 3-17y Group | Influsplit Tetra_LP 3-17y Group | Influsplit Tetra_IP 6-35m Group | Influsplit Tetra_LP 6-35m Group | Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm. | Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm. | Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28). | Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28). | Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28). | Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28). | Total of all reporting groups |
| Overall Participants | 60 | 60 | 410 | 411 | 466 | 474 | 1881 |
| Age (Years) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [Years] |
29.8
(8.7)
|
31.2
(9.3)
|
9.4
(4.2)
|
9.4
(4.2)
|
NA
(NA)
|
NA
(NA)
|
12.1
(8.67)
|
| Age (Months) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [Months] |
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
19.7
(8.0)
|
19.9
(8.3)
|
19.8
(8.15)
|
| Sex: Female, Male (Count of Participants) | |||||||
| Female |
41
68.3%
|
35
58.3%
|
196
47.8%
|
187
45.5%
|
223
47.9%
|
209
44.1%
|
891
47.4%
|
| Male |
19
31.7%
|
25
41.7%
|
214
52.2%
|
224
54.5%
|
243
52.1%
|
265
55.9%
|
990
52.6%
|
Outcome Measures
| Title | Number of Subjects Aged 18-49 Years Reporting Solicited Local Adverse Events (AEs). |
|---|---|
| Description | Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = significant pain at rest and pain that prevented normal everyday activities. Grade 3 redness and swelling = greater than 100 millimeters (mm) i.e. >100mm. |
| Time Frame | During the 7-day (Days 0-6) post-vaccination period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented. |
| Arm/Group Title | Influsplit Tetra_IP Adult Group | Influsplit Tetra_LP Adult Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm. | Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm. |
| Measure Participants | 60 | 59 |
| Any Pain |
41
|
32
|
| Grade 3 Pain |
1
|
0
|
| Any Redness |
1
|
1
|
| Grade 3 Redness |
0
|
0
|
| Any Swelling |
2
|
4
|
| Grade 3 Swelling |
0
|
0
|
| Title | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. |
|---|---|
| Description | Solicited general symptoms assessed were fatigue,gastrointestinal symptoms, headache, Joint Pain, myalgia, shivering and fever. Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Grade 3 was defined as symptoms that prevented normal activities. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Any fever was defined as subjects with a documented temperature of greater than or equal to (≥) 38°C/100.4°F by any route and all subjects reporting temperature less than (< )38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever was defined as temperature ≥39.0°C. |
| Time Frame | During the 7-day (Days 0-6) post-vaccination period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented. |
| Arm/Group Title | Influsplit Tetra_IP Adult Group | Influsplit Tetra_LP Adult Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm. | Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm. |
| Measure Participants | 60 | 59 |
| Any Fatigue |
32
|
20
|
| Grade 3 Fatigue |
0
|
0
|
| Related Fatigue |
28
|
20
|
| Any Gastrointestinal symptoms |
6
|
6
|
| Grade 3 Gastrointestinal symptoms |
0
|
0
|
| Related Gastrointestinal symptoms |
4
|
4
|
| Any Headache |
30
|
16
|
| Grade 3 Headache |
1
|
1
|
| Related Headache |
26
|
14
|
| Any Joint Pain |
8
|
5
|
| Grade 3 Joint Pain |
0
|
0
|
| Related Joint Pain |
8
|
5
|
| Any Myalgia |
21
|
13
|
| Grade 3 Myalgia |
1
|
0
|
| Related Myalgia |
20
|
13
|
| Any Shivering |
9
|
7
|
| Grade 3 Shivering |
1
|
0
|
| Related Shivering |
8
|
6
|
| Any Fever |
2
|
2
|
| Fever (≥38.0°C) |
2
|
1
|
| Grade 3 Fever |
0
|
0
|
| Related Fever |
2
|
2
|
| ≥38.0°C Related Fever |
2
|
1
|
| Title | Duration of Solicited Local and General AEs in Subjects Aged 18-49 Years. |
|---|---|
| Description | Duration was defined as number of days with any grade of local and general symptoms. |
| Time Frame | During the 7-day (Days 0-6) post-vaccination period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented. N = Number of subjects with the symptom and without the missing confirmed grade |
| Arm/Group Title | Influsplit Tetra_IP Adult Group | Influsplit Tetra_LP Adult Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm. | Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm. |
| Measure Participants | 41 | 32 |
| Fatigue |
2.0
|
2.0
|
| Gastrointestinal symptoms |
1.5
|
1.0
|
| Headache |
1.0
|
1.5
|
| Joint Pain |
1.0
|
3.0
|
| Myalgia |
2.0
|
2.0
|
| Pain |
2.0
|
2.0
|
| Redness |
2.0
|
1.0
|
| Shivering |
2.0
|
3.0
|
| Swelling |
1.5
|
2.5
|
| Fever |
1.0
|
1.5
|
| Title | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. |
|---|---|
| Description | Oculorespiratory syndrome (ORS) was defined as the occurrence within 24 hours after vaccination of one or more of the following newly onset symptoms: bilateral red eyes, cough, wheeze, chest tightness, difficulty breathing, difficulty swallowing, hoarseness, sore throat, facial swelling. Any was defined as any ORS symptom regardless of intensity grade or relationship to vaccination. Grade 3 ORS was defined as ORS symptoms that prevented normal activities. Related ORS was defined as ORS symptom(s) assessed by the investigator as causally related to the vaccination. |
| Time Frame | During the 3-day (Days 0-2) post-vaccination period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented. |
| Arm/Group Title | Influsplit Tetra_IP Adult Group | Influsplit Tetra_LP Adult Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm. | Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm. |
| Measure Participants | 60 | 59 |
| Any Chest Tightness |
0
|
0
|
| Grade 3 Chest Tightness |
0
|
0
|
| Related Chest Tightness |
0
|
0
|
| Any Cough |
3
|
2
|
| Grade 3 Cough |
0
|
0
|
| Related Cough |
3
|
1
|
| Any Difficulty Breathing |
0
|
0
|
| Grade 3 Difficulty Breathing |
0
|
0
|
| Related Difficulty Breathing |
0
|
0
|
| Any Hoarseness |
1
|
1
|
| Grade 3 Hoarseness |
0
|
0
|
| Related Hoarseness |
1
|
1
|
| Any Red Eyes |
1
|
1
|
| Grade 3 Red Eyes |
0
|
0
|
| Related Red Eyes |
1
|
0
|
| Any Sore Throat |
4
|
2
|
| Grade 3 Sore Throat |
0
|
0
|
| Related Sore Throat |
3
|
1
|
| Any Swallowing Difficulty |
3
|
1
|
| Grade 3 Swallowing Difficulty |
0
|
0
|
| Related Swallowing Difficulty |
2
|
0
|
| Any Swelling of the face |
0
|
0
|
| Grade 3 Swelling of the face |
0
|
0
|
| Related Swelling of the face |
0
|
0
|
| Any Wheezing |
0
|
0
|
| Grade 3 Wheezing |
0
|
0
|
| Related Wheezing |
0
|
0
|
| Title | Number of Subjects Aged 18-49 Years Reporting the Occurrence of Medically Attended Events (MAEs). |
|---|---|
| Description | MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s). Grade 3 was defined as MAE that prevented normal activities. Related was defined as MAE assessed by the investigator to be causally related to the study vaccination. |
| Time Frame | During the entire study period (approximately 21 days following vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented. 1 subject withdrew consent in the Influsplit Tetra_LP Adult Group and did not complete the study but was administered a study vaccine dose. |
| Arm/Group Title | Influsplit Tetra_IP Adult Group | Influsplit Tetra_LP Adult Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm. | Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm. |
| Measure Participants | 60 | 60 |
| Any MAE(s) |
9
|
8
|
| Grade 3 MAE(s) |
3
|
1
|
| Related MAE(s) |
0
|
0
|
| Title | Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). |
|---|---|
| Description | Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling = greater than 50 millimeters (mm) i.e. >50mm. |
| Time Frame | During the 7-day (Days 0-6) post-vaccination period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 17 years, with at least one vaccine administration documented. |
| Arm/Group Title | Influsplit Tetra_IP 3-17y Group | Influsplit Tetra_LP 3-17y Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28). | Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28). |
| Measure Participants | 410 | 410 |
| Any Pain, Dose 1 |
243
|
253
|
| Grade 3 Pain, Dose 1 |
14
|
20
|
| Any Redness, Dose 1 |
118
|
119
|
| Grade 3 Redness, Dose 1 |
8
|
7
|
| Any Swelling, Dose 1 |
102
|
100
|
| Grade 3 Swelling, Dose 1 |
7
|
7
|
| Any Pain, Dose 2 |
36
|
39
|
| Grade 3 Pain, Dose 2 |
0
|
2
|
| Any Redness, Dose 2 |
25
|
21
|
| Grade 3 Redness, Dose 2 |
0
|
0
|
| Any Swelling, Dose 2 |
16
|
17
|
| Grade 3 Swelling, Dose 2 |
1
|
0
|
| Any Pain, Across Doses |
252
|
264
|
| Grade 3 Pain, Across Doses |
14
|
21
|
| Any Redness, Across Doses |
129
|
128
|
| Grade 3 Redness, Across Doses |
8
|
7
|
| Any Swelling, Across Doses |
109
|
110
|
| Grade 3 Swelling, Across Doses |
8
|
7
|
| Title | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. |
|---|---|
| Description | Solicited general symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity. Any fever was defined as subjects with a documented temperature of greater than or equal to (≥) 38°C/100.4°F by any route and all subjects reporting temperature less than (< )38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever was defined as temperature greater than (>) 39.0°C. |
| Time Frame | During the 7-day (Days 0-6) post-vaccination period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 4 years, with at least one vaccine administration documented. |
| Arm/Group Title | Influsplit Tetra_IP 3-4y Group | Influsplit Tetra_LP 3-4y Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 3 to 4 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28). | Subjects in the Influsplit Tetra_LP group aged between 3 to 4 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28). |
| Measure Participants | 70 | 72 |
| Any Drowsiness, Dose 1 |
14
|
7
|
| Grade 3 Drowsiness, Dose 1 |
0
|
1
|
| Related Drowsiness, Dose 1 |
10
|
4
|
| Any Irritability, Dose 1 |
9
|
12
|
| Grade 3 Irritability, Dose 1 |
1
|
1
|
| Related Irritability, Dose 1 |
6
|
8
|
| Any Loss of appetite, Dose 1 |
9
|
14
|
| Grade 3 Loss of appetite, Dose 1 |
2
|
1
|
| Related Loss of appetite, Dose 1 |
6
|
6
|
| Any Fever, Dose 1 |
5
|
7
|
| Fever (≥38.0°C), Dose 1 |
4
|
7
|
| Grade 3 Fever, Dose 1 |
1
|
3
|
| Related Fever, Dose 1 |
1
|
5
|
| ≥38.0°C Related Fever, Dose 1 |
1
|
5
|
| Any Drowsiness, Dose 2 |
5
|
6
|
| Grade 3 Drowsiness, Dose 2 |
0
|
1
|
| Related Drowsiness, Dose 2 |
3
|
4
|
| Any Irritability, Dose 2 |
2
|
8
|
| Grade 3 Irritability, Dose 2 |
0
|
0
|
| Related Irritability, Dose 2 |
2
|
6
|
| Any Loss of appetite, Dose 2 |
4
|
6
|
| Grade 3 Loss of appetite, Dose 2 |
0
|
0
|
| Related Loss of appetite, Dose 2 |
2
|
3
|
| Any Fever, Dose 2 |
0
|
4
|
| Fever (≥38.0°C), Dose 2] |
0
|
3
|
| Grade 3 Fever, Dose 2 |
0
|
0
|
| Related Fever, Dose 2 |
0
|
2
|
| ≥38.0°C Related Fever, Dose 2 |
0
|
1
|
| Any Drowsiness, Across Doses |
16
|
11
|
| Grade 3 Drowsiness, Across Doses |
0
|
2
|
| Related Drowsiness, Across Doses |
10
|
8
|
| Any Irritability, Across Doses |
10
|
16
|
| Grade 3 Irritability ,Across Doses |
1
|
1
|
| Related Irritability, Across Doses |
7
|
11
|
| Any Loss of appetite,Across Doses |
13
|
16
|
| Grade 3 Loss of appetite, Across Doses |
2
|
1
|
| Related Loss of appetite, Across Doses |
8
|
8
|
| Any Fever, Across Doses |
5
|
10
|
| Fever (≥38.0°C), Across Doses |
4
|
9
|
| Grade 3 Fever, Across Doses |
1
|
3
|
| Related Fever, Across Doses |
1
|
6
|
| ≥38.0°C Related Fever, Across Doses |
1
|
5
|
| Title | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. |
|---|---|
| Description | Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, joint pain, myalgia, shivering and fever (Fever = temperature above 38.0 degrees Celsius (°C)). Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Any fever = all subjects with a documented temperature of ≥ 38°C/100.4°F by any route and all subjects reporting temperature < 38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever = temperature above 39.0°C. |
| Time Frame | During the 7-day (Days 0-6) post-vaccination period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 5 to 17 years, with at least one vaccine administration documented. |
| Arm/Group Title | Influsplit Tetra_IP 5-17y Group | Influsplit Tetra_LP 5-17y Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 5 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28). | Subjects in the Influsplit Tetra_LP group aged between 5 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28). |
| Measure Participants | 340 | 338 |
| Any Fatigue, Dose 1 |
94
|
99
|
| Grade 3 Fatigue, Dose 1 |
8
|
13
|
| Related Fatigue, Dose 1 |
65
|
70
|
| Any Gastrointestinal, Dose 1 |
35
|
32
|
| Grade 3 Gastrointestinal, Dose 1 |
2
|
1
|
| Related Gastrointestinal, Dose 1 |
18
|
16
|
| Any Headache, Dose 1 |
82
|
76
|
| Grade 3 Headache, Dose 1 |
3
|
9
|
| Related Headache, Dose 1 |
46
|
50
|
| Any Joint Pain, Dose 1 |
34
|
38
|
| Grade 3 Joint Pain, Dose 1 |
3
|
2
|
| Related Joint Pain, Dose 1 |
25
|
29
|
| Any Myalgia, Dose 1 |
70
|
84
|
| Grade 3 Myalgia, Dose 1 |
3
|
5
|
| Related Myalgia, Dose 1 |
55
|
72
|
| Any Shivering, Dose 1 |
20
|
29
|
| Grade 3 Shivering, Dose 1 |
0
|
3
|
| Related Shivering, Dose 1 |
16
|
20
|
| Any Fever, Dose 1 |
12
|
9
|
| Fever (≥38.0°C), Dose 1 |
11
|
8
|
| Grade 3 Fever, Dose 1 |
0
|
0
|
| Related Fever, Dose 1 |
10
|
7
|
| ≥38.0°C Related Fever, Dose 1 |
9
|
6
|
| Any Fatigue, Dose 2 |
8
|
4
|
| Grade 3 Fatigue, Dose 2 |
0
|
0
|
| Related Fatigue, Dose 2 |
4
|
4
|
| Any Gastrointestinal, Dose 2 |
3
|
1
|
| Grade 3 Gastrointestinal, Dose 2 |
0
|
0
|
| Related Gastrointestinal, Dose 2 |
0
|
0
|
| Any Headache, Dose 2 |
2
|
7
|
| Grade 3 Headache, Dose 2 |
0
|
0
|
| Related Headache, Dose 2 |
2
|
4
|
| Any Joint Pain, Dose 2 |
2
|
4
|
| Grade 3 Joint Pain, Dose 2 |
1
|
0
|
| Related Joint Pain, Dose 2 |
1
|
3
|
| Any Myalgia, Dose 2 |
3
|
9
|
| Grade 3 Myalgia, Dose 2 |
1
|
0
|
| Related Myalgia, Dose 2 |
2
|
7
|
| Any Shivering, Dose 2 |
2
|
2
|
| Grade 3 Shivering, Dose 2 |
0
|
0
|
| Related Shivering, Dose 2 |
0
|
1
|
| Any Fever, Dose 2 |
3
|
0
|
| Fever (≥38.0°C), Dose 2 |
2
|
0
|
| Grade 3 Fever, Dose 2 |
1
|
0
|
| Related Fever, Dose 2 |
2
|
0
|
| ≥38.0°C Related Fever, Dose 2 |
1
|
0
|
| Any Fatigue, Across Doses |
97
|
101
|
| Grade 3 Fatigue, Across Doses |
8
|
13
|
| Related Fatigue, Across Doses |
66
|
72
|
| Any Gastrointestinal, Across Doses |
38
|
32
|
| Grade 3 Gastrointestinal, Across Doses |
2
|
1
|
| Related Gastrointestinal, Across Doses |
18
|
16
|
| Any Headache, Across Doses |
83
|
80
|
| Grade 3 Headache, Across Doses |
3
|
9
|
| Related Headache, Across Doses |
48
|
53
|
| Any Joint Pain, Across Doses |
35
|
42
|
| Grade 3 Joint Pain, Across Doses |
4
|
2
|
| Related Joint Pain, Across Doses |
25
|
32
|
| Any Myalgia, Across Doses |
71
|
88
|
| Grade 3 Myalgia, Across Doses |
4
|
5
|
| Related Myalgia, Across Doses |
56
|
76
|
| Any Shivering, Across Doses |
21
|
31
|
| Grade 3 Shivering, Across Doses |
0
|
3
|
| Related Shivering, Across Doses |
16
|
21
|
| Any Fever, Across Doses |
14
|
9
|
| Fever (≥38.0°C), Across Doses |
12
|
8
|
| Grade 3 Fever, Across Doses |
1
|
0
|
| Related Fever, Across Doses |
12
|
7
|
| ≥38.0°C Related Fever, Across Doses |
10
|
6
|
| Title | Duration of Solicited Local AEs in Subjects Aged 3-17 Years. |
|---|---|
| Description | Duration was defined as number of days with any grade of local symptoms. |
| Time Frame | During the 7-day (Days 0-6) post-vaccination period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 17 years, with at least one vaccine administration documented. |
| Arm/Group Title | Influsplit Tetra_IP 3-17y Group | Influsplit Tetra_LP 3-17y Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28). | Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28). |
| Measure Participants | 243 | 253 |
| Pain, Dose 1 |
2.0
|
2.0
|
| Pain, Dose 2 |
1.0
|
2.0
|
| Redness, Dose 1 |
2.0
|
2.0
|
| Redness, Dose 2 |
2.0
|
1.0
|
| Swelling, Dose 1 |
2.0
|
2.0
|
| Swelling, Dose 2 |
2.0
|
2.0
|
| Title | Duration of Solicited General AEs in Subjects Aged 3-4 Years. |
|---|---|
| Description | Duration was defined as number of days with any grade of general symptoms. |
| Time Frame | During the 7-day (Days 0-6) post-vaccination period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 4 years, with at least one vaccine administration documented. |
| Arm/Group Title | Influsplit Tetra_IP 3-4y Group | Influsplit Tetra_LP 3-4y Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 3 to 4 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28). | Subjects in the Influsplit Tetra_LP group aged between 3 to 4 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28). |
| Measure Participants | 14 | 14 |
| Drowsiness, Dose 1 |
1.0
|
1.0
|
| Drowsiness, Dose 2 |
1.0
|
2.0
|
| Irritability, Dose 1 |
2.0
|
1.0
|
| Irritability, Dose 2 |
1.0
|
1.0
|
| Loss of appetite, Dose 1 |
3.0
|
2.0
|
| Loss of appetite, Dose 2 |
1.0
|
4.0
|
| Fever, Dose 1 |
2.0
|
1.0
|
| Fever, Dose 2 |
NA
|
1.5
|
| Title | Duration of Solicited General AEs in Subjects Aged 5-17 Years. |
|---|---|
| Description | Duration was defined as number of days with any grade of general symptoms. |
| Time Frame | During the 7-day (Days 0-6) post-vaccination period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 5 to 17 years, with at least one vaccine administration documented. |
| Arm/Group Title | Influsplit Tetra_IP 5-17y Group | Influsplit Tetra_LP 5-17y Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 5 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28). | Subjects in the Influsplit Tetra_LP group aged between 5 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28). |
| Measure Participants | 94 | 99 |
| Fatigue, Dose 1 |
2.0
|
2.0
|
| Fatigue, Dose 2 |
1.0
|
1.5
|
| Gastrointestinal symptoms, Dose 1 |
1.0
|
1.0
|
| Gastrointestinal symptoms, Dose 2 |
2.0
|
1.0
|
| Headache, Dose 1 |
1.0
|
2.0
|
| Headache, Dose 2 |
2.5
|
2.0
|
| Joint Pain, Dose 1 |
2.0
|
1.0
|
| Joint Pain, Dose 2 |
1.0
|
1.0
|
| Myalgia, Dose 1 |
2.0
|
1.0
|
| Myalgia, Dose 2 |
1.0
|
1.0
|
| Shivering, Dose 1 |
1.0
|
1.0
|
| Shivering, Dose 2 |
1.0
|
1.0
|
| Fever, Dose 1 |
1.0
|
1.0
|
| Fever, Dose 2 |
2.0
|
NA
|
| Title | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. |
|---|---|
| Description | Oculorespiratory syndrome (ORS) was defined as the occurrence within 24 hours after vaccination of one or more of the following newly onset symptoms: bilateral red eyes, cough, wheeze, chest tightness, difficulty breathing, difficulty swallowing, hoarseness, sore throat, facial swelling. Any = occurrence of any ORS symptom regardless of intensity grade or relationship to vaccination. Grade 3 = ORS symptoms that prevented normal activities. Related = ORS symptom assessed by the investigator as causally related to the vaccination. |
| Time Frame | During the 3-day (Days 0-2) post-vaccination period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 17 years, with at least one vaccine administration documented. |
| Arm/Group Title | Influsplit Tetra_IP 3-17y Group | Influsplit Tetra_LP 3-17y Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28). | Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28). |
| Measure Participants | 410 | 410 |
| Any Chest Tightness, Dose 1 |
2
|
6
|
| Grade 3 Chest Tightness, Dose 1 |
0
|
0
|
| Related Chest Tightness, Dose 1 |
0
|
3
|
| Any Cough, Dose 1 |
35
|
31
|
| Grade 3 Cough, Dose 1 |
2
|
1
|
| Related Cough, Dose 1 |
12
|
10
|
| Any Difficulty Breathing, Dose 1 |
5
|
11
|
| Grade 3 Difficulty Breathing, Dose 1 |
0
|
0
|
| Related Difficulty Breathing, Dose 1 |
2
|
7
|
| Any Hoarseness, Dose 1 |
10
|
12
|
| Grade 3 Hoarseness, Dose 1 |
0
|
0
|
| Related Hoarseness, Dose 1 |
2
|
6
|
| Any Red Eyes, Dose 1 |
14
|
12
|
| Grade 3 Red Eyes, Dose 1 |
0
|
0
|
| Related Red Eyes, Dose 1 |
6
|
9
|
| Any Sore throat, Dose 1 |
14
|
18
|
| Grade 3 Sore throat, Dose 1 |
1
|
0
|
| Related Sore throat, Dose 1 |
2
|
9
|
| Any Swallowing Difficulty, Dose 1 |
5
|
6
|
| Grade 3 Swallowing Difficulty, Dose 1 |
0
|
0
|
| Related Swallowing Difficulty, Dose 1 |
1
|
3
|
| Any Swelling of the face, Dose 1 |
3
|
2
|
| Grade 3 Swelling of the face, Dose 1 |
0
|
0
|
| Related Swelling of the face, Dose 1 |
3
|
2
|
| Any Wheezing, Dose 1 |
1
|
5
|
| Grade 3 Wheezing, Dose 1 |
0
|
0
|
| Related Wheezing, Dose 1 |
1
|
4
|
| Any Chest Tightness, Dose 2 |
0
|
0
|
| Grade 3 Chest Tightness, Dose 2 |
0
|
0
|
| Related Chest Tightness, Dose 2 |
0
|
0
|
| Any Cough, Dose 2 |
6
|
13
|
| Grade 3 Cough, Dose 2 |
0
|
2
|
| Related Cough, Dose 2 |
1
|
1
|
| Any Difficulty Breathing, Dose 2 |
0
|
2
|
| Grade 3 Difficulty Breathing, Dose 2 |
0
|
0
|
| Related Difficulty Breathing, Dose 2 |
0
|
0
|
| Any Hoarseness, Dose 2 |
2
|
3
|
| Grade 3 Hoarseness, Dose 2 |
0
|
0
|
| Related Hoarseness, Dose 2 |
1
|
0
|
| Any Red Eyes, Dose 2 |
0
|
1
|
| Grade 3 Red Eyes, Dose 2 |
0
|
1
|
| Related Red Eyes, Dose 2 |
0
|
1
|
| Any Sore Throat, Dose 2 |
2
|
3
|
| Grade 3 Sore Throat, Dose 2 |
0
|
1
|
| Related Sore Throat, Dose 2 |
0
|
0
|
| Any Swallowing Difficulty, Dose 2 |
2
|
1
|
| Grade 3 Swallowing Difficulty, Dose 2 |
0
|
1
|
| Related Swallowing Difficulty, Dose 2 |
1
|
0
|
| Any Swelling of the face, Dose 2 |
0
|
1
|
| Grade 3 Swelling of the face, Dose 2 |
0
|
0
|
| Related Swelling of the face, Dose 2 |
0
|
0
|
| Any Wheezing, Dose 2 |
0
|
2
|
| Grade 3 Wheezing, Dose 2 |
0
|
0
|
| Related Wheezing, Dose 2 |
0
|
0
|
| Any Chest Tightness, Across Doses |
2
|
6
|
| Grade 3 Chest Tightness, Across Doses |
0
|
0
|
| Related Chest Tightness, Across Doses |
0
|
3
|
| Any Cough, Across Doses |
39
|
39
|
| Grade 3 Cough, Across Doses |
2
|
3
|
| Related Cough, Across Doses |
13
|
11
|
| Any Difficulty Breathing, Across Doses |
5
|
13
|
| Grade 3 Difficulty Breathing, Across Doses |
0
|
0
|
| Related Difficulty Breathing, Across Doses |
2
|
7
|
| Any Hoarseness, Across Doses |
11
|
15
|
| Grade 3 Hoarseness, Across Doses |
0
|
0
|
| Related Hoarseness, Across Doses |
3
|
6
|
| Any Red Eyes, Across Doses |
14
|
13
|
| Grade 3 Red Eyes, Across Doses |
0
|
1
|
| Related Red Eyes, Across Doses |
6
|
10
|
| Any Sore Throat, Across Doses |
15
|
21
|
| Grade 3 Sore Throat, Across Doses |
1
|
1
|
| Related Sore Throat, Across Doses |
2
|
9
|
| Any Swallowing Difficulty, Across Doses |
6
|
7
|
| Grade 3 Swallowing Difficulty, Across Doses |
0
|
1
|
| Related Swallowing Difficulty, Across Doses |
2
|
3
|
| Any Swelling of the face, Across Doses |
3
|
3
|
| Grade 3 Swelling of the face, Across Doses |
0
|
0
|
| Related Swelling of the face, Across Doses |
3
|
2
|
| Any Wheezing, Across Doses |
1
|
7
|
| Grade 3 Wheezing, Across Doses |
0
|
0
|
| Related Wheezing, Across Doses |
1
|
4
|
| Title | Number of Subjects Aged 3-17 Years Reporting the Occurrence of All Medically Attended Events (MAEs) . |
|---|---|
| Description | MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s). Grade 3 was a MAE that prevented normal activities. Related was defined as a MAE assessed by the investigator to be causally related to the study vaccination. |
| Time Frame | During the entire study period (approximately 28 days (primed subjects) and 56 days (unprimed subjects) following vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 17 years, with at least one vaccine administration documented. |
| Arm/Group Title | Influsplit Tetra_IP 3-17y Group | Influsplit Tetra_LP 3-17y Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28). | Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28). |
| Measure Participants | 410 | 411 |
| Any MAE(s) |
59
|
52
|
| Grade 3 MAE(s) |
7
|
6
|
| Related MAE(s) |
2
|
0
|
| Title | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) |
|---|---|
| Description | An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. |
| Time Frame | During the 21-day (Days 0-20) follow-up period after vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented. |
| Arm/Group Title | Influsplit Tetra_IP Adult Group | Influsplit Tetra_LP Adult Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm. | Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm. |
| Measure Participants | 60 | 60 |
| Any Unsolicited AEs |
14
|
14
|
| Grade 3 Unsolicited AEs |
3
|
2
|
| Related Unsolicited AEs |
2
|
1
|
| Title | Number of Subjects Aged 3-17 Years Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). |
|---|---|
| Description | An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. |
| Time Frame | During the 28-day (Days 0-27) follow-up period after vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 months to 17 years, with at least one vaccine administration documented. |
| Arm/Group Title | Influsplit Tetra_IP 3-17y Group | Influsplit Tetra_LP 3-17y Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28). | Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28). |
| Measure Participants | 410 | 411 |
| Any Unsolicited AEs |
83
|
86
|
| Grade 3 Unsolicited AEs |
12
|
8
|
| Related Unsolicited AEs |
10
|
7
|
| Title | Number of Subjects Aged 6-35 Months Reporting Fever ≥38ºC Across Doses. |
|---|---|
| Description | Any fever = all subjects with a documented temperature of ≥ 38°C/100.4°F by any route and all subjects reporting temperature < 38°C but with missing values (MC) for at least one day during the solicited period. |
| Time Frame | During 7 days (Days 0-6) post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented. |
| Arm/Group Title | Influsplit Tetra_IP 6-35m Group | Influsplit Tetra_LP 6-35m Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28). | Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28). |
| Measure Participants | 462 | 470 |
| Any Fever |
76
|
70
|
| Fever (≥38°C) |
72
|
69
|
| Title | Number of Subjects Aged 18-49 Years, Reporting Any and Related Serious Adverse Events (SAEs) |
|---|---|
| Description | A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination. |
| Time Frame | During the entire study period (approximately 21 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented. |
| Arm/Group Title | Influsplit Tetra_IP Adult Group | Influsplit Tetra_LP Adult Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm. | Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm. |
| Measure Participants | 60 | 60 |
| Any SAEs |
1
|
1
|
| Related SAEs |
0
|
0
|
| Title | Number of Subjects Aged 3-17 Years, Reporting Any and Related Serious Adverse Events (SAEs) |
|---|---|
| Description | A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination. |
| Time Frame | During the entire study period [approximately 28 days (primed subjects) and 56 days (unprimed subjects)] |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 17 years, with at least one vaccine administration documented. |
| Arm/Group Title | Influsplit Tetra_IP 3-17y Group | Influsplit Tetra_LP 3-17y Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28). | Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28). |
| Measure Participants | 410 | 411 |
| Any SAEs |
1
|
0
|
| Related SAEs |
0
|
0
|
| Title | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. |
|---|---|
| Description | HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), FluA/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria). |
| Time Frame | At Day 28 post last vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 3 to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available |
| Arm/Group Title | Influsplit Tetra_IP 3-17y Group | Influsplit Tetra_LP 3-17y Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28). | Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28). |
| Measure Participants | 403 | 402 |
| H1N1 |
698.0
|
694.1
|
| H3N2 |
158.2
|
171.4
|
| Yamagata |
479.0
|
527.6
|
| Victoria |
237.6
|
253.7
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Influsplit Tetra_IP Adult Group, Influsplit Tetra_LP Adult Group |
|---|---|---|
| Comments | The adjusted GMT of HI antibodies for H1N1 strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra_LP/ Influsplit Tetra_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (D-QIV_LP/ D-QIV_IP) is ≤ 1.5. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted GMT Ratio |
| Estimated Value | 0.97 | |
| Confidence Interval |
(2-Sided) 95% 0.85 to 1.11 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance). | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Influsplit Tetra_IP Adult Group, Influsplit Tetra_LP Adult Group |
|---|---|---|
| Comments | The adjusted GMT of HI antibodies for H3N2 strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra_LP/Influsplit Tetra_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra_LP/ Influsplit Tetra_IP) is ≤ 1.5. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted GMT Ratio |
| Estimated Value | 1.05 | |
| Confidence Interval |
(2-Sided) 95% 0.94 to 1.18 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance). | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Influsplit Tetra_IP Adult Group, Influsplit Tetra_LP Adult Group |
|---|---|---|
| Comments | The adjusted GMT of HI antibodies for Yamagata strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra_LP/Influsplit Tetra_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra_LP/ Influsplit Tetra_IP) is ≤ 1.5 | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted GMT Ratio |
| Estimated Value | 1.03 | |
| Confidence Interval |
(2-Sided) 95% 0.91 to 1.16 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance). | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Influsplit Tetra_IP Adult Group, Influsplit Tetra_LP Adult Group |
|---|---|---|
| Comments | The adjusted GMT of HI antibodies for Victoria strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra_LP/Influsplit Tetra_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra_LP/ Influsplit Tetra_IP) is ≤ 1.5. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted GMT Ratio |
| Estimated Value | 1.04 | |
| Confidence Interval |
(2-Sided) 95% 0.90 to 1.21 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance). | |
| Title | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. |
|---|---|
| Description | HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), FluA/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria). |
| Time Frame | At Day 28 post last vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 6 to 35 months, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available |
| Arm/Group Title | Influsplit Tetra_IP 6-35m Group | Influsplit Tetra_LP 6-35m Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28). | Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28). |
| Measure Participants | 432 | 427 |
| H1N1 |
97.5
|
105.5
|
| H3N2 |
45.2
|
59.9
|
| Yamagata |
100.8
|
105.4
|
| Victoria |
32.1
|
38.0
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Influsplit Tetra_IP Adult Group, Influsplit Tetra_LP Adult Group |
|---|---|---|
| Comments | The adjusted GMT of HI antibodies for H1N1 strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra_LP/Influsplit Tetra_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra_LP/Influsplit Tetra_IP) is ≤ 1.5. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted GMT ratio |
| Estimated Value | 1.07 | |
| Confidence Interval |
(2-Sided) 95% 0.90 to 1.28 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Influsplit Tetra_IP Adult Group, Influsplit Tetra_LP Adult Group |
|---|---|---|
| Comments | The adjusted GMT of HI antibodies for H3N2 strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra_LP/Influsplit Tetra_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra_LP/Influsplit Tetra_IP) is ≤ 1.5 | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted GMT Ratio |
| Estimated Value | 1.18 | |
| Confidence Interval |
(2-Sided) 95% 1.00 to 1.39 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance). | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Influsplit Tetra_IP Adult Group, Influsplit Tetra_LP Adult Group |
|---|---|---|
| Comments | The adjusted GMT of HI antibodies for Yamagata strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra_LP/Influsplit Tetra_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra_LP/Influsplit Tetra_IP) is ≤ 1.5. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted GMT Ratio |
| Estimated Value | 1.07 | |
| Confidence Interval |
(2-Sided) 95% 0.91 to 1.27 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Influsplit Tetra_IP Adult Group, Influsplit Tetra_LP Adult Group |
|---|---|---|
| Comments | The adjusted GMT of HI antibodies for Victoria strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra_LP/Influsplit Tetra_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra_LP/Influsplit Tetra_IP) is ≤ 1.5. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Adjusted GMT Ratio |
| Estimated Value | 1.17 | |
| Confidence Interval |
(2-Sided) 95% 0.99 to 1.38 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance). | |
| Title | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 18-49 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains |
|---|---|
| Description | HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria). |
| Time Frame | At Day 0 and Day 21 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Adult According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 18 to 49 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available. |
| Arm/Group Title | Influsplit Tetra_IP Adult Group | Influsplit Tetra_LP Adult Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm. | Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm. |
| Measure Participants | 57 | 58 |
| [H1N1, Day 0] |
48.3
|
53.6
|
| [H1N1, Day 21] |
655.7
|
632.2
|
| [H3N2, Day 0] |
16.7
|
16.0
|
| [H3N2, Day 21 |
80.5
|
73.0
|
| [Yamagata, Day 0] |
133.3
|
101.6
|
| [Yamagata, Day 21] |
591.4
|
598.6
|
| [Victoria, Day 0] |
38.6
|
34.8
|
| [Victoria, Day 21] |
263.4
|
302.9
|
| Title | Number of Seroconverted Subjects Aged 18-49 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. |
|---|---|
| Description | A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria). |
| Time Frame | At Day 21 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Adult According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 18 to 49 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available. |
| Arm/Group Title | Influsplit Tetra_IP Adult Group | Influsplit Tetra_LP Adult Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm. | Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm. |
| Measure Participants | 57 | 57 |
| H1N1 |
42
|
42
|
| H3N2 |
30
|
29
|
| Yamagata |
27
|
36
|
| Victoria |
36
|
40
|
| Title | Number of Subjects Aged 18-49 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. |
|---|---|
| Description | A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria). |
| Time Frame | At Day 0 and Day 21 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Adult According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 18 to 49 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available. |
| Arm/Group Title | Influsplit Tetra_IP Adult Group | Influsplit Tetra_LP Adult Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm. | Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm. |
| Measure Participants | 57 | 58 |
| [H1N1, Day 0] |
35
|
35
|
| [H1N1, Day 21] |
56
|
57
|
| [H3N2, Day 0] |
15
|
14
|
| [H3N2, Day 21] |
49
|
49
|
| [Yamagata, Day 0] |
52
|
50
|
| [Yamagata, Day 21] |
57
|
57
|
| [Victoria, Day 0] |
34
|
32
|
| [Victoria, Day 21] |
57
|
57
|
| Title | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 18-49 Years. |
|---|---|
| Description | MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria). |
| Time Frame | At Day 21 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Adult According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 18 to 49 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available. |
| Arm/Group Title | Influsplit Tetra_IP Adult Group | Influsplit Tetra_LP Adult Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm. | Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm. |
| Measure Participants | 57 | 57 |
| H1N1 |
13.6
|
11.5
|
| H3N2 |
4.8
|
4.6
|
| Yamagata |
4.4
|
6.0
|
| Victoria |
6.8
|
8.6
|
| Title | Number of Subjects Aged 5-17 Years Reporting Myalgia Across Doses. |
|---|---|
| Description | Any = occurrence of any myalgia symptom regardless of intensity grade or relationship to vaccination. |
| Time Frame | During the 7-day (Days 0-6) post-vaccination period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 5 to 17 years, with at least one vaccine administration documented. |
| Arm/Group Title | Influsplit Tetra_IP 5-17y Group | Influsplit Tetra_LP 5-17y Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 5 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28). | Subjects in the Influsplit Tetra_LP group aged between 5 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28). |
| Measure Participants | 340 | 338 |
| Number [Subjects] |
71
|
88
|
| Title | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains |
|---|---|
| Description | HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria). |
| Time Frame | At Day 0 and Day 28 post last vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 3 to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were avail |
| Arm/Group Title | Influsplit Tetra_IP 3-17y Group | Influsplit Tetra_LP 3-17y Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28). | Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28). |
| Measure Participants | 403 | 402 |
| [H1N1, Day 0] |
80.2
|
87.7
|
| [H1N1, Day 28] |
698.0
|
694.1
|
| [H3N2, Day 0] |
38.9
|
41.9
|
| [H3N2, Day 28] |
158.2
|
171.4
|
| [Yamagata, Day 0] |
58.1
|
70.8
|
| [Yamagata, Day 28] |
479.0
|
527.6
|
| [Victoria, Day 0] |
27.3
|
28.8
|
| [Victoria, Day 28] |
237.6
|
253.7
|
| Title | Number of Seroconverted Subjects Aged 3-17 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. |
|---|---|
| Description | A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria). |
| Time Frame | At Day 28 post last vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 3 to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available |
| Arm/Group Title | Influsplit Tetra_IP 3-17y Group | Influsplit Tetra_LP 3-17y Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28). | Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28). |
| Measure Participants | 403 | 402 |
| H1N1 |
274
|
269
|
| H3N2 |
192
|
183
|
| Yamagata |
273
|
268
|
| Victoria |
285
|
287
|
| Title | Number of Subjects Aged 3-17 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. |
|---|---|
| Description | A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria). |
| Time Frame | At Day 0 and Day 28 post last vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 6 months to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available |
| Arm/Group Title | Influsplit Tetra_IP 3-17y Group | Influsplit Tetra_LP 3-17y Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28). | Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28). |
| Measure Participants | 403 | 402 |
| [H1N1, Day 0] |
308
|
314
|
| [H1N1, Day 28] |
393
|
395
|
| [H3N2, Day 0] |
245
|
252
|
| [H3N2, Day 28] |
377
|
378
|
| [Yamagata, Day 0] |
266
|
281
|
| [Yamagata, Day 28] |
396
|
395
|
| [Victoria, Day 0] |
192
|
195
|
| [Victoria, Day 28] |
375
|
374
|
| Title | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 3-17 Years. |
|---|---|
| Description | MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria). |
| Time Frame | At Day 28 post last vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 3 to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available |
| Arm/Group Title | Influsplit Tetra_IP 3-17y Group | Influsplit Tetra_LP 3-17y Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28). | Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28). |
| Measure Participants | 403 | 402 |
| H1N1 |
8.7
|
7.9
|
| H3N2 |
4.1
|
4.1
|
| Yamagata |
8.2
|
7.4
|
| Victoria |
8.7
|
8.8
|
| Title | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains |
|---|---|
| Description | HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria). |
| Time Frame | At Day 0 and Day 28 post last vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 6 months to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available |
| Arm/Group Title | Influsplit Tetra_IP 6-35m Group | Influsplit Tetra_LP 6-35m Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28). | Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28). |
| Measure Participants | 432 | 427 |
| H1N1, Day 0 |
11.1
|
11.2
|
| H1N1, Day 28 |
97.5
|
105.5
|
| H3N2, Day 0 |
7.5
|
8.4
|
| H3N2, Day 28 |
45.2
|
59.9
|
| Yamagata, Day 0 |
8.3
|
7.9
|
| Yamagata, Day 28 |
100.8
|
105.4
|
| Victoria, Day 0 |
5.7
|
5.7
|
| Victoria, Day 28 |
32.1
|
38.0
|
| Title | Number of Seroconverted Subjects Aged 6-35 Months for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. |
|---|---|
| Description | A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria). |
| Time Frame | At Day 28 post last vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 6 months to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available |
| Arm/Group Title | Influsplit Tetra_IP 6-35m Group | Influsplit Tetra_LP 6-35m Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28). | Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28). |
| Measure Participants | 432 | 427 |
| H1N1 |
287
|
275
|
| H3N2 |
217
|
236
|
| Yamagata |
318
|
321
|
| Victoria |
213
|
211
|
| Title | Number of Subjects Aged 6-35 Months, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. |
|---|---|
| Description | A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria). |
| Time Frame | At Day 0 and Day 28 post last vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 6 months to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available |
| Arm/Group Title | Influsplit Tetra_IP 6-35m Group | Influsplit Tetra_LP 6-35m Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28). | Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28). |
| Measure Participants | 432 | 427 |
| H1N1, Day 0 |
84
|
83
|
| H1N1, Day 28 |
303
|
289
|
| H3N2, Day 0 |
55
|
67
|
| H3N2, Day 28 |
232
|
259
|
| Yamagata, Day 0 |
53
|
49
|
| Yamagata, Day 28 |
329
|
331
|
| Victoria, Day 0 |
17
|
16
|
| Victoria, Day 28 |
214
|
217
|
| Title | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 6-35 Months. |
|---|---|
| Description | MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria). |
| Time Frame | At Day 28 post last vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 6 months to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available |
| Arm/Group Title | Influsplit Tetra_IP 6-35m Group | Influsplit Tetra_LP 6-35m Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28). | Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28). |
| Measure Participants | 432 | 427 |
| H1N1 |
8.8
|
9.5
|
| H3N2 |
6.0
|
7.1
|
| Yamagata |
12.2
|
13.3
|
| Victoria |
5.6
|
6.6
|
| Title | Number of Subjects Aged 6-35 Months Reporting Fever ≥38ºC After Dose 1 and After Dose 2. |
|---|---|
| Description | Any fever = all subjects with a documented temperature of ≥ 38°C/100.4°F by any route and all subjects reporting temperature < 38°C but with missing values (MC) for at least one day during the solicited period. Fever = temperature of ≥ 38°C/100.4°F by any route |
| Time Frame | During 7 days (Days 0-6) post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented. |
| Arm/Group Title | Influsplit Tetra_IP 6-35m Group | Influsplit Tetra_LP 6-35m Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28). | Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28). |
| Measure Participants | 462 | 470 |
| Any Fever, Dose 1 |
42
|
44
|
| Fever (≥38°C), Dose 1 |
39
|
42
|
| Any Fever, Dose 2 |
41
|
40
|
| Fever (≥38°C), Dose 2 |
40
|
40
|
| Title | Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). |
|---|---|
| Description | Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = significant pain at rest and pain that prevented normal everyday activities. Grade 3 redness and swelling = greater than 50 millimeters (mm) i.e. > 50mm. |
| Time Frame | During the 7-day (Days 0-6) post-vaccination period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented. |
| Arm/Group Title | Influsplit Tetra_IP 6-35m Group | Influsplit Tetra_LP 6-35m Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28). | Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28). |
| Measure Participants | 462 | 470 |
| Any Pain, Dose 1 |
69
|
77
|
| Grade 3 Pain, Dose 1 |
1
|
2
|
| Any Redness, Dose 1 |
88
|
86
|
| Grade 3 Redness, Dose 1 |
0
|
0
|
| Any Swelling, Dose 1 |
33
|
42
|
| Grade 3 Swelling, Dose 1 |
0
|
0
|
| Any Pain, Dose 2 |
47
|
48
|
| Grade 3 Pain, Dose 2 |
1
|
4
|
| Any Redness, Dose 2 |
61
|
66
|
| Grade 3 Redness, Dose 2 |
0
|
0
|
| Any Swelling, Dose 2 |
32
|
27
|
| Grade 3 Swelling, Dose 2 |
0
|
1
|
| Any Pain, Across Doses |
89
|
98
|
| Grade 3 Pain, Across Doses |
2
|
4
|
| Any Redness, Across Doses |
106
|
106
|
| Grade 3 Redness, Across Doses |
0
|
0
|
| Any Swelling, Across Doses |
50
|
51
|
| Grade 3 Swelling, Across Doses |
0
|
1
|
| Title | Number of Subjects Aged 6 Months to <5 Years, Reporting Fever ≥38ºC (100.4°F) and >39.0°C (102.2ºF) Across Doses. |
|---|---|
| Description | Any fever = all subjects with a documented temperature of ≥ 38°C/100.4°F by any route and all subjects reporting temperature < 38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever = temperature above 39.0°C/102.2ºF. Data of 2 independent groups were pooled. |
| Time Frame | During the 2 days (Day 0-Day 1) post-vaccination period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 months to <5 years, with at least one vaccine administration documented. |
| Arm/Group Title | Influsplit Tetra_IP 6m-<5y Group | Influsplit Tetra_LP 6m-<5y Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 6 months to <5 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28). | Subjects in the Influsplit Tetra_LP group aged between 6 months to <5 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28). |
| Measure Participants | 532 | 542 |
| Any Fever |
29
|
31
|
| Fever (≥38°C) |
28
|
31
|
| Grade 3 Fever |
4
|
1
|
| Title | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. |
|---|---|
| Description | Solicited general symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity. Any fever was defined as subjects with a documented temperature of greater than or equal to (≥) 38°C/100.4°F by any route and all subjects reporting temperature less than (< )38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever was defined as temperature greater than (>)39.0°C. |
| Time Frame | During the 7-day (Days 0-6) post-vaccination period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented. |
| Arm/Group Title | Influsplit Tetra_IP 6-35m Group | Influsplit Tetra_LP 6-35m Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28). | Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28). |
| Measure Participants | 462 | 470 |
| Any Drowsiness, Dose 1 |
87
|
77
|
| Grade 3 Drowsiness, Dose 1 |
3
|
7
|
| Related Drowsiness, Dose 1 |
54
|
50
|
| Any Irritability, Dose 1 |
124
|
96
|
| Grade 3 Irritability, Dose 1 |
10
|
10
|
| Related Irritability, Dose 1 |
75
|
58
|
| Any Loss of appetite, Dose 1 |
94
|
76
|
| Grade 3 Loss of appetite, Dose 1 |
9
|
8
|
| Related Loss of appetite, Dose 1 |
47
|
40
|
| Any Fever, Dose 1 |
42
|
44
|
| Fever (≥38.0°C), Dose 1 |
39
|
42
|
| Grade 3 Fever, Dose 1 |
8
|
5
|
| Related Fever, Dose 1 |
16
|
23
|
| ≥38.0°C Related Fever, Dose 1 |
14
|
22
|
| Any Drowsiness, Dose 2 |
63
|
58
|
| Grade 3 Drowsiness, Dose 2 |
6
|
7
|
| Related Drowsiness, Dose 2 |
46
|
35
|
| Any Irritability, Dose 2 |
87
|
87
|
| Grade 3 Irritability, Dose 2 |
5
|
8
|
| Related Irritability, Dose 2 |
59
|
50
|
| Any Loss Of Appetite, Dose 2 |
64
|
69
|
| Grade 3 Loss Of Appetite, Dose 2 |
4
|
10
|
| Related Loss Of Appetite, Dose 2 |
39
|
37
|
| Any Fever, Dose 2 |
41
|
40
|
| Fever (≥38.0°C), Dose 2 |
40
|
40
|
| Grade 3 Fever, Dose 2 |
10
|
9
|
| Related Fever, Dose 2 |
19
|
17
|
| ≥38.0°C Related Fever, Dose 2 |
19
|
17
|
| Any Drowsiness, Across Doses |
115
|
103
|
| Grade 3 Drowsiness, Across Doses |
8
|
13
|
| Related Drowsiness, Across Doses |
78
|
66
|
| Any Irritability, Across Doses |
155
|
141
|
| Grade 3 Irritability, Across Doses |
15
|
17
|
| Related Irritability, Across Doses |
98
|
87
|
| Any Loss Of Appetite, Across Doses |
127
|
116
|
| Grade 3 Loss Of Appetite, Across Doses |
13
|
17
|
| Related Loss Of Appetite, Across Doses |
69
|
61
|
| Any Fever, Across Doses |
76
|
70
|
| Fever (≥38.0°C), Across Doses |
72
|
69
|
| Grade 3 Fever, Across Doses |
18
|
14
|
| Related Fever, Across Doses |
32
|
35
|
| ≥38.0°C Related Fever, Across Doses |
30
|
34
|
| Title | Duration of Solicited Local AEs in Subjects Aged 6-35 Months. |
|---|---|
| Description | Duration was defined as number of days with any grade of local symptoms. |
| Time Frame | During the 7-day (Days 0-6) post-vaccination period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented. |
| Arm/Group Title | Influsplit Tetra_IP 6-35m Group | Influsplit Tetra_LP 6-35m Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28). | Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28). |
| Measure Participants | 88 | 86 |
| Pain, Dose 1 |
1.0
|
1.0
|
| Pain, Dose 2 |
2.0
|
2.0
|
| Redness, Dose 1 |
2.0
|
2.0
|
| Redness, Dose 2 |
2.0
|
2.0
|
| Swelling, Dose 1 |
1.0
|
1.0
|
| Swelling, Dose 2 |
2.0
|
2.0
|
| Title | Duration of Solicited General AEs in Subjects Aged 6-35 Months. |
|---|---|
| Description | Duration was defined as number of days with any grade of general symptoms. |
| Time Frame | During the 7-day (Days 0-6) post-vaccination period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented. |
| Arm/Group Title | Influsplit Tetra_IP 6-35m Group | Influsplit Tetra_LP 6-35m Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28). | Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28). |
| Measure Participants | 124 | 96 |
| Drowsiness, Dose 1 |
2.0
|
2.0
|
| Drowsiness, Dose 2 |
2.0
|
2.0
|
| Irritability, Dose 1 |
2.0
|
2.0
|
| Irritability, Dose 2 |
2.0
|
2.0
|
| Loss of appetite, Dose 1 |
2.0
|
2.0
|
| Loss of appetite, Dose 2 |
2.0
|
2.0
|
| Fever, Dose 1 |
2.0
|
1.0
|
| Fever, Dose 2 |
1.0
|
2.0
|
| Title | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. |
|---|---|
| Description | Oculorespiratory syndrome (ORS) was defined as the occurrence within 24 hours after vaccination of one or more of the following newly onset symptoms: bilateral red eyes, cough, wheeze, chest tightness, difficulty breathing, difficulty swallowing, hoarseness, sore throat, facial swelling. Any = occurrence of any ORS symptom regardless of intensity grade or relationship to vaccination. Grade 3 = ORS symptoms that prevented normal activities. Related = ORS symptom assessed by the investigator as causally related to the vaccination. |
| Time Frame | During a 3 day (Days 0-2) follow-up period after vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented. |
| Arm/Group Title | Influsplit Tetra_IP 6-35m Group | Influsplit Tetra_LP 6-35m Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28). | Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28). |
| Measure Participants | 462 | 470 |
| Any Chest Tightness, Dose 1 |
2
|
1
|
| Grade 3 Chest Tightness, Dose 1 |
0
|
0
|
| Related Chest Tightness, Dose 1 |
0
|
0
|
| Any Cough, Dose 1 |
47
|
50
|
| Grade 3 Cough, Dose 1 |
3
|
3
|
| Related Cough, Dose 1 |
16
|
13
|
| Any Difficulty Breathing, Dose 1 |
15
|
12
|
| Grade 3 Difficulty Breathing, Dose 1 |
1
|
1
|
| Related Difficulty Breathing, Dose 1 |
4
|
2
|
| Any Hoarseness, Dose 1 |
13
|
11
|
| Grade 3 Hoarseness, Dose 1 |
0
|
0
|
| Related Hoarseness, Dose 1 |
1
|
4
|
| Any Red Eyes, Dose 1 |
10
|
11
|
| Grade 3 Red Eyes, Dose 1 |
0
|
0
|
| Related Red Eyes, Dose 1 |
6
|
5
|
| Any Sore throat, Dose 1 |
6
|
7
|
| Grade 3 Sore throat, Dose 1 |
0
|
0
|
| Related Sore throat, Dose 1 |
1
|
3
|
| Any Swallowing Difficulty, Dose 1 |
1
|
5
|
| Grade 3 Swallowing Difficulty, Dose 1 |
0
|
0
|
| Related Swallowing Difficulty, Dose 1 |
0
|
2
|
| Any Swelling of the face, Dose 1 |
4
|
3
|
| Grade 3 Swelling of the face, Dose 1 |
0
|
0
|
| Related Swelling of the face, Dose 1 |
1
|
1
|
| Any Wheezing, Dose 1 |
9
|
12
|
| Grade 3 Wheezing, Dose 1 |
1
|
1
|
| Related Wheezing, Dose 1 |
3
|
3
|
| Any Chest Tightness, Dose 2 |
9
|
4
|
| Grade 3 Chest Tightness, Dose 2 |
0
|
2
|
| Related Chest Tightness, Dose 2 |
0
|
1
|
| Any Cough, Dose 2 |
37
|
53
|
| Grade 3 Cough, Dose 2 |
5
|
3
|
| Related Cough, Dose 2 |
8
|
8
|
| Any Difficulty Breathing, Dose 2 |
19
|
18
|
| Grade 3 Difficulty Breathing, Dose 2 |
1
|
2
|
| Related Difficulty Breathing, Dose 2 |
5
|
3
|
| Any Hoarseness, Dose 2 |
13
|
9
|
| Grade 3 Hoarseness, Dose 2 |
0
|
1
|
| Related Hoarseness, Dose 2 |
1
|
1
|
| Any Red Eyes, Dose 2 |
10
|
11
|
| Grade 3 Red Eyes, Dose 2 |
0
|
0
|
| Related Red Eyes, Dose 2 |
6
|
1
|
| Any Sore Throat, Dose 2 |
7
|
11
|
| Grade 3 Sore Throat, Dose 2 |
1
|
1
|
| Related Sore Throat, Dose 2 |
0
|
2
|
| Any Swallowing Difficulty, Dose 2 |
8
|
7
|
| Grade 3 Swallowing Difficulty, Dose 2 |
2
|
1
|
| Related Swallowing Difficulty, Dose 2 |
0
|
1
|
| Any Swelling of the face, Dose 2 |
5
|
4
|
| Grade 3 Swelling of the face, Dose 2 |
0
|
0
|
| Related Swelling of the face, Dose 2 |
1
|
1
|
| Any Wheezing, Dose 2 |
11
|
16
|
| Grade 3 Wheezing, Dose 2 |
3
|
1
|
| Related Wheezing, Dose 2 |
4
|
3
|
| Any Chest Tightness, Across Doses |
10
|
5
|
| Grade 3 Chest Tightness, Across Doses |
0
|
2
|
| Related Chest Tightness, Across Doses |
0
|
1
|
| Any Cough, Across Doses |
73
|
85
|
| Grade 3 Cough, Across Doses |
8
|
6
|
| Related Cough, Across Doses |
22
|
18
|
| Any Difficulty Breathing, Across Doses |
31
|
25
|
| Grade 3 Difficulty Breathing, Across Doses |
2
|
3
|
| Related Difficulty Breathing, Across Doses |
8
|
4
|
| Any Hoarseness, Across Doses |
23
|
17
|
| Grade 3 Hoarseness, Across Doses |
0
|
1
|
| Related Hoarseness, Across Doses |
2
|
5
|
| Any Red Eyes, Across Doses |
18
|
19
|
| Grade 3 Red Eyes, Across Doses |
0
|
0
|
| Related Red Eyes, Across Doses |
10
|
5
|
| Any Sore Throat, Across Doses |
12
|
17
|
| Grade 3 Sore Throat, Across Doses |
1
|
1
|
| Related Sore Throat, Across Doses |
1
|
5
|
| Any Swallowing Difficulty, Across Doses |
8
|
12
|
| Grade 3 Swallowing Difficulty, Across Doses |
2
|
1
|
| Related Swallowing Difficulty, Across Doses |
0
|
3
|
| Any Swelling of the face, Across Doses |
9
|
7
|
| Grade 3 Swelling of the face,Across Doses |
0
|
0
|
| Related Swelling of the face,Across Doses |
2
|
2
|
| Any Wheezing, Across Doses |
19
|
26
|
| Grade 3 Wheezing, Across Doses |
4
|
2
|
| Related Wheezing, Across Doses |
7
|
5
|
| Title | Number of Subjects Aged 6-35 Months Reporting the Occurrence of All Medically Attended Events (MAEs) |
|---|---|
| Description | MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s). Grade 3 was a MAE that prevented normal activities. Related was defined as a MAE assessed by the investigator to be causally related to the study vaccination. |
| Time Frame | During the entire study period (approximately 28 days (primed subjects) and 56 days (unprimed subjects) following vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented. |
| Arm/Group Title | Influsplit Tetra_IP 6-35m Group | Influsplit Tetra_LP 6-35m Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28). | Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28). |
| Measure Participants | 466 | 474 |
| Any MAE(s) |
235
|
252
|
| Grade 3 MAE(s) |
35
|
29
|
| Related MAE(s) |
2
|
0
|
| Title | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). |
|---|---|
| Description | An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 unsolicited AE was defined as an event that prevented normal activity. Related unsolicited AE was defined as an event assessed by the investigator to be causally related to the study vaccination. |
| Time Frame | During the 28-day (Days 0-27) follow-up period after vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented. |
| Arm/Group Title | Influsplit Tetra_IP 6-35m Group | Influsplit Tetra_LP 6-35m Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28). | Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28). |
| Measure Participants | 466 | 474 |
| Any Unsolicited AEs |
243
|
262
|
| Grade 3 Unsolicited AEs |
33
|
31
|
| Related Unsolicited AEs |
6
|
3
|
| Title | Number of Subjects Aged 6-35 Months, Reporting Any and Related Serious Adverse Events (SAEs) |
|---|---|
| Description | A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination. |
| Time Frame | During the entire study period [approximately 28 days (primed subjects) and 56 days (unprimed subjects)] |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented. |
| Arm/Group Title | Influsplit Tetra_IP 6-35m Group | Influsplit Tetra_LP 6-35m Group |
|---|---|---|
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28). | Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28). |
| Measure Participants | 466 | 474 |
| Any SAEs |
7
|
11
|
| Related SAEs |
0
|
0
|
Adverse Events
| Time Frame | Serious Adverse Events: From Day 0 to Day 56; Solicited local and genera l symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||
| Arm/Group Title | Influsplit Tetra_IP Adult Group | Influsplit Tetra_LP Adult Group | Influsplit Tetra_IP 3-17 y | Influsplit Tetra_LP 3-17 y | Influsplit Tetra_IP 6-35 m | Influsplit Tetra_LP 6-35 m | ||||||
| Arm/Group Description | Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm. | Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm. | Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28). | Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28). | Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28). | Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28). | ||||||
All Cause Mortality |
||||||||||||
| Influsplit Tetra_IP Adult Group | Influsplit Tetra_LP Adult Group | Influsplit Tetra_IP 3-17 y | Influsplit Tetra_LP 3-17 y | Influsplit Tetra_IP 6-35 m | Influsplit Tetra_LP 6-35 m | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/60 (0%) | 0/60 (0%) | 0/410 (0%) | 0/411 (0%) | 0/466 (0%) | 0/474 (0%) | ||||||
Serious Adverse Events |
||||||||||||
| Influsplit Tetra_IP Adult Group | Influsplit Tetra_LP Adult Group | Influsplit Tetra_IP 3-17 y | Influsplit Tetra_LP 3-17 y | Influsplit Tetra_IP 6-35 m | Influsplit Tetra_LP 6-35 m | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/60 (1.7%) | 1/60 (1.7%) | 1/410 (0.2%) | 0/411 (0%) | 7/466 (1.5%) | 11/474 (2.3%) | ||||||
| Infections and infestations | ||||||||||||
| Meningitis viral | 0/60 (0%) | 0/60 (0%) | 1/410 (0.2%) | 0/411 (0%) | 0/466 (0%) | 0/474 (0%) | ||||||
| Gastroenteritis | 0/60 (0%) | 0/60 (0%) | 0/410 (0%) | 0/411 (0%) | 3/466 (0.6%) | 2/474 (0.4%) | ||||||
| Bronchitis | 0/60 (0%) | 0/60 (0%) | 0/410 (0%) | 0/411 (0%) | 2/466 (0.4%) | 2/474 (0.4%) | ||||||
| Bronchiolitis | 0/60 (0%) | 0/60 (0%) | 0/410 (0%) | 0/411 (0%) | 0/466 (0%) | 2/474 (0.4%) | ||||||
| Adenovirus infection | 0/60 (0%) | 0/60 (0%) | 0/410 (0%) | 0/411 (0%) | 0/466 (0%) | 1/474 (0.2%) | ||||||
| Bronchopneumonia | 0/60 (0%) | 0/60 (0%) | 0/410 (0%) | 0/411 (0%) | 1/466 (0.2%) | 0/474 (0%) | ||||||
| Epstein-Barr virus infection | 0/60 (0%) | 0/60 (0%) | 0/410 (0%) | 0/411 (0%) | 0/466 (0%) | 1/474 (0.2%) | ||||||
| Haemophilus infection | 0/60 (0%) | 0/60 (0%) | 0/410 (0%) | 0/411 (0%) | 0/466 (0%) | 1/474 (0.2%) | ||||||
| Otitis media | 0/60 (0%) | 0/60 (0%) | 0/410 (0%) | 0/411 (0%) | 0/466 (0%) | 1/474 (0.2%) | ||||||
| Pneumonia respiratory syncytial viral | 0/60 (0%) | 0/60 (0%) | 0/410 (0%) | 0/411 (0%) | 1/466 (0.2%) | 0/474 (0%) | ||||||
| Pseudocroup | 0/60 (0%) | 0/60 (0%) | 0/410 (0%) | 0/411 (0%) | 0/466 (0%) | 1/474 (0.2%) | ||||||
| Respiratory syncytial virus bronchiolitis | 0/60 (0%) | 0/60 (0%) | 0/410 (0%) | 0/411 (0%) | 0/466 (0%) | 1/474 (0.2%) | ||||||
| Upper respiratory tract infection | 0/60 (0%) | 0/60 (0%) | 0/410 (0%) | 0/411 (0%) | 1/466 (0.2%) | 0/474 (0%) | ||||||
| Viral infection | 0/60 (0%) | 0/60 (0%) | 0/410 (0%) | 0/411 (0%) | 0/466 (0%) | 1/474 (0.2%) | ||||||
| Injury, poisoning and procedural complications | ||||||||||||
| Post procedural inflammation | 0/60 (0%) | 1/60 (1.7%) | 0/410 (0%) | 0/411 (0%) | 0/466 (0%) | 0/474 (0%) | ||||||
| Metabolism and nutrition disorders | ||||||||||||
| Dehydration | 0/60 (0%) | 0/60 (0%) | 0/410 (0%) | 0/411 (0%) | 1/466 (0.2%) | 0/474 (0%) | ||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||
| Back pain | 1/60 (1.7%) | 0/60 (0%) | 0/410 (0%) | 0/411 (0%) | 0/466 (0%) | 0/474 (0%) | ||||||
| Nervous system disorders | ||||||||||||
| Febrile convulsion | 0/60 (0%) | 0/60 (0%) | 0/410 (0%) | 0/411 (0%) | 0/466 (0%) | 1/474 (0.2%) | ||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| Bronchospasm | 0/60 (0%) | 0/60 (0%) | 0/410 (0%) | 0/411 (0%) | 1/466 (0.2%) | 1/474 (0.2%) | ||||||
| Asthma | 0/60 (0%) | 0/60 (0%) | 0/410 (0%) | 0/411 (0%) | 1/466 (0.2%) | 0/474 (0%) | ||||||
Other (Not Including Serious) Adverse Events |
||||||||||||
| Influsplit Tetra_IP Adult Group | Influsplit Tetra_LP Adult Group | Influsplit Tetra_IP 3-17 y | Influsplit Tetra_LP 3-17 y | Influsplit Tetra_IP 6-35 m | Influsplit Tetra_LP 6-35 m | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 51/60 (85%) | 42/60 (70%) | 327/410 (79.8%) | 324/411 (78.8%) | 315/466 (67.6%) | 319/474 (67.3%) | ||||||
| Gastrointestinal disorders | ||||||||||||
| Gastrointestinal disorder | 6/60 (10%) | 6 | 6/60 (10%) | 6 | 38/410 (9.3%) | 38 | 32/411 (7.8%) | 33 | 0/466 (0%) | 0 | 0/474 (0%) | 0 |
| Dysphagia | 3/60 (5%) | 3 | 1/60 (1.7%) | 1 | 0/410 (0%) | 1 | 0/411 (0%) | 1 | 0/466 (0%) | 1 | 0/474 (0%) | 1 |
| General disorders | ||||||||||||
| Chills | 9/60 (15%) | 9 | 7/60 (11.7%) | 7 | 21/410 (5.1%) | 22 | 31/411 (7.5%) | 31 | 1/466 (0.2%) | 1 | 0/474 (0%) | 0 |
| Fatigue | 32/60 (53.3%) | 32 | 20/60 (33.3%) | 20 | 97/410 (23.7%) | 102 | 101/411 (24.6%) | 103 | 0/466 (0%) | 0 | 0/474 (0%) | 0 |
| Pain | 41/60 (68.3%) | 41 | 32/60 (53.3%) | 32 | 252/410 (61.5%) | 279 | 264/411 (64.2%) | 294 | 89/466 (19.1%) | 117 | 98/474 (20.7%) | 125 |
| Pyrexia | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 21/410 (5.1%) | 22 | 24/411 (5.8%) | 25 | 95/466 (20.4%) | 112 | 92/474 (19.4%) | 111 |
| Swelling | 2/60 (3.3%) | 2 | 4/60 (6.7%) | 4 | 109/410 (26.6%) | 118 | 110/411 (26.8%) | 117 | 50/466 (10.7%) | 65 | 51/474 (10.8%) | 69 |
| Infections and infestations | ||||||||||||
| Bronchitis | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 5/410 (1.2%) | 5 | 4/411 (1%) | 4 | 39/466 (8.4%) | 49 | 56/474 (11.8%) | 64 |
| Gastroenteritis | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 2/410 (0.5%) | 2 | 4/411 (1%) | 4 | 31/466 (6.7%) | 33 | 37/474 (7.8%) | 44 |
| Nasopharyngitis | 1/60 (1.7%) | 1 | 4/60 (6.7%) | 4 | 4/410 (1%) | 4 | 6/411 (1.5%) | 6 | 26/466 (5.6%) | 27 | 29/474 (6.1%) | 30 |
| Upper respiratory tract infection | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 13/410 (3.2%) | 14 | 17/411 (4.1%) | 18 | 62/466 (13.3%) | 80 | 73/474 (15.4%) | 82 |
| Metabolism and nutrition disorders | ||||||||||||
| Decreased appetite | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 13/410 (3.2%) | 13 | 16/411 (3.9%) | 20 | 127/466 (27.3%) | 158 | 116/474 (24.5%) | 145 |
| Musculoskeletal and connective tissue disorders | ||||||||||||
| Arthralgia | 8/60 (13.3%) | 8 | 5/60 (8.3%) | 5 | 35/410 (8.5%) | 36 | 42/411 (10.2%) | 43 | 0/466 (0%) | 0 | 0/474 (0%) | 0 |
| Myalgia | 21/60 (35%) | 21 | 13/60 (21.7%) | 13 | 72/410 (17.6%) | 74 | 90/411 (21.9%) | 96 | 0/466 (0%) | 0 | 0/474 (0%) | 0 |
| Nervous system disorders | ||||||||||||
| Headache | 31/60 (51.7%) | 32 | 16/60 (26.7%) | 17 | 85/410 (20.7%) | 89 | 84/411 (20.4%) | 88 | 0/466 (0%) | 0 | 1/474 (0.2%) | 1 |
| Somnolence | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 16/410 (3.9%) | 19 | 11/411 (2.7%) | 13 | 115/466 (24.7%) | 150 | 103/474 (21.7%) | 135 |
| Psychiatric disorders | ||||||||||||
| Irritability | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 10/410 (2.4%) | 11 | 16/411 (3.9%) | 20 | 155/466 (33.3%) | 211 | 141/474 (29.7%) | 183 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| Cough | 3/60 (5%) | 3 | 2/60 (3.3%) | 2 | 43/410 (10.5%) | 46 | 44/411 (10.7%) | 51 | 86/466 (18.5%) | 99 | 100/474 (21.1%) | 124 |
| Dyspnoea | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 6/410 (1.5%) | 6 | 13/411 (3.2%) | 13 | 31/466 (6.7%) | 34 | 25/474 (5.3%) | 30 |
| Oropharyngeal pain | 4/60 (6.7%) | 4 | 3/60 (5%) | 3 | 16/410 (3.9%) | 17 | 23/411 (5.6%) | 23 | 13/466 (2.8%) | 14 | 18/474 (3.8%) | 20 |
| Wheezing | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 1/410 (0.2%) | 1 | 7/411 (1.7%) | 7 | 19/466 (4.1%) | 20 | 26/474 (5.5%) | 28 |
| Skin and subcutaneous tissue disorders | ||||||||||||
| Erythema | 0/60 (0%) | 0 | 0/60 (0%) | 0 | 131/410 (32%) | 145 | 128/411 (31.1%) | 140 | 106/466 (22.7%) | 149 | 107/474 (22.6%) | 153 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
| Name/Title | GSK Response Center |
|---|---|
| Organization | GlaxoSmithKline |
| Phone | 866-435-7343 |
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT02207413
Other Study ID Numbers:
- 201251
First Posted:
Aug 4, 2014
Last Update Posted:
Jun 6, 2018
Last Verified:
May 1, 2018