Study to Evaluate the Safety of Co-administration of GSK Biologicals' Poliorix and Infanrix in Healthy Children in Russia

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01094171
• Collaborator: (none)
• Enrollment: 400
• Locations: 2
• Arm: 1
• Actual Duration (Months): 22.8
• Patients Per Site: 200
• Patients Per Site Per Month: 8.8

Study Details

Study Description

Brief Summary

The purpose of this study is to assess reactogenicity and safety of simultaneous administration of GSK Biologicals' inactivated poliomyelitis vaccine Poliorix and GSK Biologicals' DTPa-vaccine Infanrix vaccines in healthy children in Russian Federation in their first year of life according to National Calendar of Prophylactic Immunisation of Russian Federation.

Condition or Disease	Intervention/Treatment	Phase
Poliomyelitis	Biological: Poliorix TM; Biological: Infanrix TM	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 400 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Phase IV (Not Interventional), Open-label, Multicentre Study to Evaluate the Reactogenicity and Safety of Co-administration of GlaxoSmithKline Biologicals' DTPa (Infanrix) and IPV (Poliorix) Vaccines Administered as Three-dose Primary Immunisation Course at 3, 4.5 and 6 Months of Age in Healthy Children in Russian Federation
• Actual Study Start Date: Dec 3, 2010
• Actual Primary Completion Date: Oct 27, 2012
• Actual Study Completion Date: Oct 27, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Poliorix Group Subjects received 3 primary doses of PoliorixTM and InfanrixTM vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).	Biological: Poliorix TM; Intramuscular administration, 3 doses; Biological: Infanrix TM; Intramuscular administration, 3 doses

Outcome Measures

Primary Outcome Measures

1. Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms [During the 4-day (Days 0 - 3) post vaccination period]

   Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as considerable pain that prevented normal everyday activities. Grade 3 redness and swelling were defined as redness and swelling greater than (>) 20 millimeters (mm)

2. Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms [During the 4-day (Days 0 - 3) post vaccination period]

   Solicited general symptoms assessed were Drowsiness, Irritability, Loss of appetite and Fever [Axillary temperature greater than or equal to (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination. Any fever = oral temperature ≥ 37.5 degrees Celsius (°C). Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature > 39.0°C.

3. Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) [During the 31-day (Days 0 - 30) post vaccination period]

   Unsolicited AE covers any AE 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.

4. Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs). [During the entire study period (Day 0 - Month 4)]

   SAEs assessed included medical occurrences 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: 3 Months to 6 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.

• A male or female aged 3 months including at the time of the vaccination.

• Written informed consent obtained from the parent of the subject.

• Healthy subjects as established by medical history and clinical examination and thermometry before entering into the study, that don't have contraindications for vaccination against diphtheria, tetanus, pertussis and poliomyelitis

Exclusion Criteria:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the booster dose of study vaccine, or planned use during the study period.

• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs from birth.

• Administration of immunoglobulins and/or any blood products from birth or planned administration during the study period.

• Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the vaccination, except recombinant hepatitis B vaccine, Haemophilus influenzae type B vaccine and seasonal/pandemic influenza prophylactic.

• Participation in another clinical study at any time during the study, in which the subject has been or will be exposed to an investigational or a non-registered product (pharmaceutical product or device).

• Previous vaccination against diphtheria, tetanus, pertussis and poliomyelitis if by any reasons it was made in timeframe not stated by National Calendar of Prophylactic Vaccines of Russian Federation.

• Medical history of convulsions and progressive neurological disease.

• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination (no laboratory testing required).

• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.

• Chronic diseases and serious congenital defects.

• Acute disease at the time of enrolment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Barnaul		Russian Federation	656056
2	GSK Investigational Site	Ekaterinburg		Russian Federation	620085

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

• Romanenko VV et al. (2016) Safety and reactogenicity of inactivated vaccine for polio prevention (Poliorix ™) output and DTP vaccine (Infanrix ™) in a joint application for trehdozovoy scheme in healthy children in Russia. Ural Med Jq. 9(142):138-144.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT01094171
• Other Study ID Numbers: 113586; 2013-002804-15
• First Posted: Mar 26, 2010
• Last Update Posted: Mar 11, 2019
• Last Verified: Feb 1, 2019

• Keywords provided by GlaxoSmithKline: poliomyelitis; diphtheria; Primary immunization; pertussis; Children; tetanus
• Additional relevant MeSH terms: Poliomyelitis

Study Results

Participant Flow

Arm/Group Title	Poliorix Group
Arm/Group Description	Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
Period Title: Overall Study
STARTED	400
COMPLETED	390
NOT COMPLETED	10

Baseline Characteristics

Arm/Group Title	Poliorix Group
Arm/Group Description	Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
Overall Participants	400
Age (Months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Months]	3.40 (0.50)
Sex: Female, Male (Count of Participants)
Female	178 44.5%
Male	222 55.5%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Description	Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as considerable pain that prevented normal everyday activities. Grade 3 redness and swelling were defined as redness and swelling greater than (>) 20 millimeters (mm)
Time Frame	During the 4-day (Days 0 - 3) post vaccination period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Poliorix Group
Arm/Group Description	Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
Measure Participants	400
[Any Pain]	114
[Grade 3 Pain]	7
[Any Redness]	258
[Grade 3 Redness]	12
[Any Swelling]	152
[Grade 3 Swelling]	8

2. Primary Outcome

Title	Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms
Description	Solicited general symptoms assessed were Drowsiness, Irritability, Loss of appetite and Fever [Axillary temperature greater than or equal to (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination. Any fever = oral temperature ≥ 37.5 degrees Celsius (°C). Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature > 39.0°C.
Time Frame	During the 4-day (Days 0 - 3) post vaccination period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Poliorix Group
Arm/Group Description	Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
Measure Participants	400
[Any Drowsiness]	227
[Grade 3 Drowsiness]	15
[Any Irritability]	240
[Grade 3 Irritability]	20
[Any Loss of appetite]	133
[Grade 3 Loss of appetite]	10
[Any Fever]	69
[Grade 3 Fever]	1

3. Primary Outcome

Title	Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
Description	Unsolicited AE covers any AE 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 31-day (Days 0 - 30) post vaccination period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Poliorix Group
Arm/Group Description	Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
Measure Participants	400
Number [Subjects]	91

4. Primary Outcome

Title	Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).
Description	SAEs assessed included medical occurrences 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 (Day 0 - Month 4)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Poliorix Group
Arm/Group Description	Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
Measure Participants	400
[Any SAEs]	4
[Related SAEs]	0

Adverse Events

Time Frame	Serious Adverse Events: From Day 0 to Month 4; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
Adverse Event Reporting Description	For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Arm/Group Title	Poliorix Group
Arm/Group Description	Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
All Cause Mortality
	Poliorix Group
	Affected / at Risk (%)	# Events
Total	0/400 (0%)
Serious Adverse Events
	Poliorix Group
	Affected / at Risk (%)	# Events
Total	4/400 (1%)
Gastrointestinal disorders
Periproctitis	1/400 (0.3%)
Diarrhoea	1/400 (0.3%)
General disorders
Body temperature increased	1/400 (0.3%)
Respiratory, thoracic and mediastinal disorders
Respiratory disorder	1/400 (0.3%)
Other (Not Including Serious) Adverse Events
	Poliorix Group
	Affected / at Risk (%)	# Events
Total	258/400 (64.5%)
General disorders
Pain	114/400 (28.5%)
Redness	258/400 (64.5%)
Swelling	152/400 (38%)
Drowsiness	227/400 (56.8%)
Irritability	240/400 (60%)
Loss of appetite	133/400 (33.3%)
Fever	69/400 (17.3%)
Body temperature increased	20/400 (5%)
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea	27/400 (6.8%)
Cough	23/400 (5.8%)

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.