Study of a Single Dose or Two Doses of a Quadrivalent Influenza Vaccine in Subjects Aged 6 Months or Older in India

• Sponsor: Sanofi Pasteur, a Sanofi Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02451358
• Collaborator: (none)
• Enrollment: 400
• Locations: 8
• Arms: 4
• Duration (Months): 18.1
• Patients Per Site: 50
• Patients Per Site Per Month: 2.8

Study Details

Study Description

Brief Summary

The aim of the study was to generate immunogenicity and safety data in the whole population to support registration of the Quadrivalent Influenza Vaccine (QIV) in India:

Primary objective:

• To describe in each age group the immune response induced by a single injection (participants aged >9 years) or 2 injections (participants aged 6 months to 8 years) of QIV.

Secondary objective:

• To describe in each age group the safety profile of QIV.

Condition or Disease	Intervention/Treatment	Phase
Influenza	Biological: Quadrivalent Inactivated Influenza Vaccine (2016-2017 NH formulation), No Preservative; Biological: Quadrivalent Inactivated Influenza Vaccine (2016 SH formulation), No Preservative; Biological: Quadrivalent Inactivated Influenza Vaccine (2015-2016 NH formulation), No Preservative; Biological: Quadrivalent Inactivated Influenza Vaccine (2015 SH formulation), No Preservative	Phase 3

Detailed Description

All participants were vaccinated with the QIV (split-virion, inactivated) Northern Hemisphere (NH) or Southern Hemisphere (SH) formulations by the intramuscular (IM) route. Immunogenicity of the vaccine was assessed at baseline (Day 0) and 28 days after the last injection. Safety data were collected up to 28 days after each injection. Serious adverse events (SAEs) were collected throughout the trial.

Study Design

• Study Type: Interventional
• Actual Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Immunogenicity and Safety of a Single Dose or Two Doses Given 28 Days Apart of a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route in Subjects Aged 6 Months or Older in India
• Study Start Date: Jul 27, 2015
• Actual Primary Completion Date: Jan 28, 2017
• Actual Study Completion Date: Jan 28, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months Participants aged 6 to 35 months received 2 doses of 0.25 mL QIV (2016-2017 NH formulation) intramuscularly, 1 injection each at Day 0 and 28.	Biological: Quadrivalent Inactivated Influenza Vaccine (2016-2017 NH formulation), No Preservative; 0.25 mL, Intramuscular; Other Names: QIV, No Preservative
Experimental: Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 SH formulation) intramuscularly, 1 injection each at Day 0 and 28.	Biological: Quadrivalent Inactivated Influenza Vaccine (2016 SH formulation), No Preservative; 0.5 mL, Intramuscular; Other Names: QIV, No Preservative
Experimental: Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0.	Biological: Quadrivalent Inactivated Influenza Vaccine (2015-2016 NH formulation), No Preservative; 0.5 mL, Intramuscular; Other Names: QIV, No Preservative
Experimental: Quadrivalent Influenza Vaccine Group 4: >=18 Years Participants aged >=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.	Biological: Quadrivalent Inactivated Influenza Vaccine (2015 SH formulation), No Preservative; 0.5 mL, Intramuscular; Other Names: QIV, No Preservative

Outcome Measures

Primary Outcome Measures

1. Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies [Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination)]

   Anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, B Victoria, B Yamagata.

2. Number of Participants With Seroprotection to Influenza Vaccine Antigens [Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination)]

   Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, B Victoria and B Yamagata. Seroprotection was defined as an antibody titer >=40 (1/dilution[dil]) at pre-vaccination and at post-final vaccination.

3. Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens [28 days post-final vaccination (post-vaccination)]

   Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, B Victoria and B Yamagata. Seroconversion was defined as pre-vaccination titer <10 (1/dil) and post-vaccination titer >=40 (1/dil), and Significant increase was defined as pre-vaccination titer >=10 (1/dil) and >= 4-fold increase of post-vaccination titer.

Secondary Outcome Measures

1. Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine [Within 7 days after any vaccination]

   Solicited injection site reactions: Age 6-23 months: Tenderness, Erythema and Swelling(Grade 3: Tenderness: cries when injected limb is moved; Erythema and Swelling:>=50 mm) Age >=2 years: Pain, Erythema and Swelling (Grade 3: Pain:unable to perform usual activities [age 2-11 years], significant interference with daily activities [age >=12 years]; Erythema and Swelling >=50 mm [age 2-11 years], >100 mm [age >=12 years]) Solicited systemic reactions: Age 6-23 months: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite loss, Irritability (Grade 3: Fever:>39.5 degree Celsius; Vomiting:>=6 episodes/24 hours; Crying abnormal:>3 hours; Drowsiness:sleeping most of the time or difficult to wake up; Appetite loss: refuses >=3 feeds/meals or most feeds/meals; Irritability: inconsolable) Age >=2 years:Fever, Headache, Malaise, Myalgia and Shivering (Grade 3:Fever>=39.0 degree Celsius; Headache, Malaise, Myalgia and Shivering:significant interference in daily activities)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Aged 6 months or older on the day of inclusion

• For participants aged 6 to 35 months only: born at full term of pregnancy (>=37 weeks) or birth weight >=2.5 kg or both

• Informed consent form had been signed and dated by the participants / participants' parent(s) or another legally acceptable representative and by an independent witness, if required by local regulations. For participants aged 7 to 17 years of age, assent form has been signed and dated by the participants

• Participants / participants' parent/legally acceptable representative were able to attend all scheduled visits and to comply with all trial procedures

Exclusion Criteria:

• For participants aged 9 years or older only: participant was pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination)

• Participation at the time of study enrollment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure

• Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks following any trial vaccination (except Oral Poliomyelitis Vaccine (OPV) received during national immunization days)

• For participants aged 9 years or older only: previous vaccination against influenza (in the previous 9 months) with any influenza vaccine

• For participants aged 6 months to 8 years only: previous priming with any influenza vaccine (i.e., participants who received 2 doses for at least 1 previous influenza season)

• Receipt of immune globulins, blood or blood-derived products in the past 3 months

• Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)

• Self-reported history of seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C, after questioning

• Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances

• Self-reported thrombocytopenia or as reported by the parent/legally acceptable representative, contraindicating intramuscular vaccination

• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination

• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily

• For participants aged 9 years or older only: current alcohol abuse or drug addiction

• Chronic illness that, in the opinion of the Investigator, was at a stage where it might interfere with trial conduct or completion

• Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (axillary temperature >=38.0 degree Celsius). A prospective participants should not be included in the study until the condition had resolved or the febrile event has subsided

• Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Vadodara	Gujarat	India	390001
2		Mandya	Karnataka	India	571401
3		Pune	Maharashtra	India	411043
4		Mumbai	Parel	India	400012
5		Pimpri	Pune	India	411018
6		Ludhiana	Punjab	India	141008
7		Kolkata	West Bengal	India	700017
8		Bangalore		India	560054

Sponsors and Collaborators

• Sanofi Pasteur, a Sanofi Company

Investigators

• Study Director: Medical Director, Sanofi Pasteur SA

Study Documents (Full-Text)

• Study Protocol - Sep 30, 2015
• Statistical Analysis Plan - Mar 4, 2016

More Information

Additional Information:

• Related Info
• Related Info

Publications

None provided.

• Responsible Party: Sanofi Pasteur, a Sanofi Company
• ClinicalTrials.gov Identifier: NCT02451358
• Other Study ID Numbers: QIV06; U1111-1143-8370; CTRI/2015/05/005770
• First Posted: May 22, 2015
• Last Update Posted: Apr 19, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Sanofi Pasteur, a Sanofi Company: Influenza; Quadrivalent Inactivated Influenza Vaccine (QIV)
• Additional relevant MeSH terms: Influenza, Human; Vaccines

Study Results

Participant Flow

Recruitment Details	Study participants were enrolled in 8 centers in India from 27 July 2015 to 26 November 2016.
Pre-assignment Detail	A total of 400 participants (100 in each group) were enrolled and vaccinated in the study.

Arm/Group Title	Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months	Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years	Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years	Quadrivalent Influenza Vaccine Group 4: >=18 Years
Arm/Group Description	Participants aged 6 to 35 months received 2 doses of 0.25 mL Quadrivalent Influenza Vaccine (QIV) (2016-2017 Northern Hemisphere (NH) formulation) intramuscularly, 1 injection each at Day 0 and 28.	Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 Southern Hemisphere (SH) formulation) intramuscularly, 1 injection each at Day 0 and 28.	Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0.	Participants aged >=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.
Period Title: Overall Study
STARTED	100	100	100	100
Vaccinated at Day 0	100	100	100	100
Vaccinated at Day 28	99	98	0	0
COMPLETED	99	98	99	100
NOT COMPLETED	1	2	1	0

Baseline Characteristics

Arm/Group Title	Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months	Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years	Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years	Quadrivalent Influenza Vaccine Group 4: >=18 Years	Total
Arm/Group Description	Participants aged 6 to 35 months received 2 doses of 0.25 mL QIV (2016-2017 NH formulation) intramuscularly, 1 injection each at Day 0 and 28.	Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 SH formulation) intramuscularly, 1 injection each at Day 0 and 28.	Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0.	Participants aged >=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.	Total of all reporting groups
Overall Participants	99	98	99	100	396
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	1.0 (0.8)	4.9 (1.5)	11.7 (2.2)	48.5 (18.8)	16.6 (21.2)
Sex: Female, Male (Count of Participants)
Female	45 45.5%	60 61.2%	50 50.5%	34 34%	189 47.7%
Male	54 54.5%	38 38.8%	49 49.5%	66 66%	207 52.3%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
India	99 100%	98 100%	99 100%	100 100%	396 100%

Outcome Measures

1. Primary Outcome

Title	Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies
Description	Anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, B Victoria, B Yamagata.
Time Frame	Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination)

Outcome Measure Data

Analysis Population Description

Analysis was performed using Full Analysis Set (FAS) which included all participants who received at least 1 dose of vaccine and had at least 1 valid post-vaccination serology result. Here, 'Number Analyzed' = those participants with available data for specified categories.

Arm/Group Title	Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months	Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years	Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years	Quadrivalent Influenza Vaccine Group 4: >=18 Years
Arm/Group Description	Participants aged 6 to 35 months received 2 doses of 0.25 mL QIV (2016-2017 NH formulation) intramuscularly, 1 injection each at Day 0 and 28.	Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 SH formulation) intramuscularly, 1 injection each at Day 0 and 28.	Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0.	Participants aged >=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.
Measure Participants	99	98	99	100
Pre-Vaccination: A/H1N1	14.4	84.1	107	44.3
Pre-Vaccination: A/H3N2	44.4	416	204	20.8
Pre-Vaccination: B Victoria	21.5	37.5	54.1	41.9
Pre-Vaccination: B Yamagata	12.0	81.1	91.7	107
Post-Vaccination: A/H1N1	723	1895	1641	1232
Post-Vaccination: A/H3N2	1016	3458	2379	980
Post-Vaccination: B Victoria	658	2222	2061	1150
Post-Vaccination: B Yamagata	951	3582	2273	1836

2. Primary Outcome

Title	Number of Participants With Seroprotection to Influenza Vaccine Antigens
Description	Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, B Victoria and B Yamagata. Seroprotection was defined as an antibody titer >=40 (1/dilution[dil]) at pre-vaccination and at post-final vaccination.
Time Frame	Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination)

Outcome Measure Data

Analysis Population Description

Analysis was performed using FAS which included all participants who received at least 1 dose of vaccine and had at least 1 valid post-vaccination serology result. Here, 'Number Analyzed' = those participants with available data for specified categories.

Arm/Group Title	Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months	Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years	Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years	Quadrivalent Influenza Vaccine Group 4: >=18 Years
Arm/Group Description	Participants aged 6 to 35 months received 2 doses of 0.25 mL QIV (2016-2017 NH formulation) intramuscularly, 1 injection each at Day 0 and 28.	Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 SH formulation) intramuscularly, 1 injection each at Day 0 and 28.	Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0.	Participants aged >=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.
Measure Participants	99	98	99	100
Pre-Vaccination: A/H1N1	23 23.2%	62 63.3%	86 86.9%	60 60%
Pre-Vaccination: A/H3N2	40 40.4%	94 95.9%	85 85.9%	34 34%
Pre-Vaccination: B Victoria	30 30.3%	47 48%	63 63.6%	53 53%
Pre-Vaccination: B Yamagata	18 18.2%	65 66.3%	74 74.7%	83 83%
Post-Vaccination: A/H1N1	93 93.9%	98 100%	99 100%	99 99%
Post-Vaccination: A/H3N2	96 97%	98 100%	99 100%	96 96%
Post-Vaccination: B Victoria	88 88.9%	98 100%	98 99%	99 99%
Post-Vaccination: B Yamagata	93 93.9%	98 100%	98 99%	97 97%

3. Primary Outcome

Title	Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens
Description	Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, B Victoria and B Yamagata. Seroconversion was defined as pre-vaccination titer <10 (1/dil) and post-vaccination titer >=40 (1/dil), and Significant increase was defined as pre-vaccination titer >=10 (1/dil) and >= 4-fold increase of post-vaccination titer.
Time Frame	28 days post-final vaccination (post-vaccination)

Outcome Measure Data

Analysis Population Description

Analysis was performed using FAS which included all participants who received at least 1 dose of vaccine and had at least 1 valid post-vaccination serology result. Here, 'Number Analyzed' = those participants with available data for specified categories.

Arm/Group Title	Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months	Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years	Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years	Quadrivalent Influenza Vaccine Group 4: >=18 Years
Arm/Group Description	Participants aged 6 to 35 months received 2 doses of 0.25 mL QIV (2016-2017 NH formulation) intramuscularly, 1 injection each at Day 0 and 28.	Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 SH formulation) intramuscularly, 1 injection each at Day 0 and 28.	Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0.	Participants aged >=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.
Measure Participants	99	98	99	100
A/H1N1	86 86.9%	87 88.8%	84 84.8%	90 90%
A/H3N2	85 85.9%	77 78.6%	71 71.7%	90 90%
B Victoria	84 84.8%	87 88.8%	95 96%	92 92%
B Yamagata	91 91.9%	91 92.9%	86 86.9%	86 86%

4. Secondary Outcome

Title	Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine
Description	Solicited injection site reactions: Age 6-23 months: Tenderness, Erythema and Swelling(Grade 3: Tenderness: cries when injected limb is moved; Erythema and Swelling:>=50 mm) Age >=2 years: Pain, Erythema and Swelling (Grade 3: Pain:unable to perform usual activities [age 2-11 years], significant interference with daily activities [age >=12 years]; Erythema and Swelling >=50 mm [age 2-11 years], >100 mm [age >=12 years]) Solicited systemic reactions: Age 6-23 months: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite loss, Irritability (Grade 3: Fever:>39.5 degree Celsius; Vomiting:>=6 episodes/24 hours; Crying abnormal:>3 hours; Drowsiness:sleeping most of the time or difficult to wake up; Appetite loss: refuses >=3 feeds/meals or most feeds/meals; Irritability: inconsolable) Age >=2 years:Fever, Headache, Malaise, Myalgia and Shivering (Grade 3:Fever>=39.0 degree Celsius; Headache, Malaise, Myalgia and Shivering:significant interference in daily activities)
Time Frame	Within 7 days after any vaccination

Outcome Measure Data

Analysis Population Description

Analysis was performed using Safety Analysis Set which included all participants who received at least 1 dose of study vaccine. Here, 'Number Analyzed' = those participants with available data for specified categories. 'Number analyzed' = 0 signifies that reported reaction was not analyzed in the specified age group.

Arm/Group Title	Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months	Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years	Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years	Quadrivalent Influenza Vaccine Group 4: >=18 Years
Arm/Group Description	Participants aged 6 to 35 months received 2 doses of 0.25 mL QIV (2016-2017 NH formulation) intramuscularly, 1 injection each at Day 0 and 28.	Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 SH formulation) intramuscularly, 1 injection each at Day 0 and 28.	Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0.	Participants aged >=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.
Measure Participants	100	100	100	100
Injection site Pain / Tenderness	12 12.1%	40 40.8%	35 35.4%	24 24%
Grade 3: Injection site Pain / Tenderness	0 0%	0 0%	0 0%	0 0%
Injection site Erythema	1 1%	3 3.1%	4 4%	0 0%
Grade 3 Injection site Erythema	0 0%	0 0%	0 0%	0 0%
Injection site Swelling	2 2%	3 3.1%	4 4%	0 0%
Grade 3 Injection site Swelling	0 0%	0 0%	0 0%	0 0%
Fever	9 9.1%	8 8.2%	2 2%	0 0%
Grade 3 Fever	0 0%	2 2%	0 0%	0 0%
Vomiting	2 2%
Grade 3 Vomiting	2 2%
Crying abnormal	1 1%
Grade 3 Crying abnormal	0 0%
Drowsiness	1 1%
Grade 3 Drowsiness	0 0%
Appetite lost	3 3%
Grade 3 Appetite lost	0 0%
Irritability	5 5.1%
Grade 3 Irritability	0 0%	0 0%
Headache	0 0%	4 4.1%	6 6.1%	1 1%
Grade 3 Headache	0 0%	1 1%	0 0%	0 0%
Malaise	0 0%	4 4.1%	7 7.1%	1 1%
Grade 3 Malaise	0 0%	0 0%	0 0%	0 0%
Myalgia	1 1%	9 9.2%	16 16.2%	3 3%
Grade 3 Myalgia	0 0%	0 0%	0 0%	0 0%
Shivering	0 0%	2 2%	0 0%	1 1%
Grade 3 Shivering	0 0%	1 1%	0 0%	0 0%

Adverse Events

Time Frame	Adverse events (AE) data were collected from Day 0 (post-vaccination) up to 28 days after the final vaccination (up to Day 56 for Group 1 and 2; Day 28 for Group 3 and 4)
Adverse Event Reporting Description	A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
Arm/Group Title	Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months		Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years		Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years		Quadrivalent Influenza Vaccine Group 4: >=18 Years
Arm/Group Description	Participants aged 6 to 35 months received 2 doses of 0.25 mL QIV (2016-2017 NH formulation) intramuscularly, 1 injection each at Day 0 and 28.		Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 SH formulation) intramuscularly, 1 injection each at Day 0 and 28.		Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0.		Participants aged >=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.
All Cause Mortality
	Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months		Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years		Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years		Quadrivalent Influenza Vaccine Group 4: >=18 Years
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/100 (0%)		0/100 (0%)		0/100 (0%)		0/100 (0%)
Serious Adverse Events
	Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months		Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years		Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years		Quadrivalent Influenza Vaccine Group 4: >=18 Years
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/100 (0%)		0/100 (0%)		0/100 (0%)		0/100 (0%)
Other (Not Including Serious) Adverse Events
	Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months		Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years		Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years		Quadrivalent Influenza Vaccine Group 4: >=18 Years
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	29/100 (29%)		50/100 (50%)		44/100 (44%)		24/100 (24%)
General disorders
Injection site pain	12/100 (12%)		40/100 (40%)		35/100 (35%)		24/100 (24%)
Malaise	0/100 (0%)		4/100 (4%)		7/100 (7%)		1/100 (1%)
Pyrexia	14/100 (14%)		8/100 (8%)		2/100 (2%)		0/100 (0%)
Infections and infestations
Upper respiratory tract infection	5/100 (5%)		3/100 (3%)		0/100 (0%)		0/100 (0%)
Musculoskeletal and connective tissue disorders
Myalgia	1/100 (1%)		9/100 (9%)		16/100 (16%)		3/100 (3%)
Nervous system disorders
Headache	0/100 (0%)		4/100 (4%)		6/100 (6%)		1/100 (1%)
Psychiatric disorders
Irritability	6/100 (6%)		0/100 (0%)		0/100 (0%)		0/100 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	3/100 (3%)		5/100 (5%)		0/100 (0%)		0/100 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.