Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00753649
• Collaborator: (none)
• Enrollment: 224
• Locations: 3
• Arms: 2
• Actual Duration (Months): 53.6
• Patients Per Site: 74.7
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

This study will evaluate GSK Biologicals' DTPa-HBV-IPV/Hib vaccine given as a three-dose primary vaccination course at 2, 4 and 6 months of age, in terms of safety and immunogenicity in different population of infants residing in Canada.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B; Tetanus; Poliomyelitis; Diphtheria; Haemophilus Influenzae Type b; Acellular Pertussis	Biological: Infanrix™ hexa	Phase 4

Detailed Description

This protocol posting has been updated following Protocol amendment 1 (19-MAY-2010).

Study Design

• Study Type: Interventional
• Actual Enrollment: 224 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Infanrix Hexa Vaccine in Healthy Infants
• Actual Study Start Date: Sep 23, 2008
• Actual Primary Completion Date: Mar 12, 2013
• Actual Study Completion Date: Mar 12, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aboriginal infants group	Biological: Infanrix™ hexa; Intramuscular, three doses; Other Names: DTPa-HBV-IPV/Hib
Active Comparator: Other Non-Aboriginal infants	Biological: Infanrix™ hexa; Intramuscular, three doses; Other Names: DTPa-HBV-IPV/Hib

Outcome Measures

Primary Outcome Measures

1. Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (Anti-PRP) [One month after (POST) Dose 3.]

   A seroprotected subject was a subject whose anti-PRP antibody concentration was greater or equal to (≥) 0.15 microgram per milliliter (µg/mL).

Secondary Outcome Measures

1. Number of Subjects With Anti-PRP Antibody Concentrations ≥1µg/mL [One month after (POST) Dose 3.]

   For this assay, 1 μg/mL was considered as the seropositivity cut-off.

2. Anti-PRP Antibody Concentrations [One month after (POST) Dose 3.]

   Anti-PRP antibody concentrations were presented as Geometric mean Concentrations (GMC), expressed as micrograms per milliliter (μg/mL).

3. Number of Seroprotected Subjects Against Hepatitis B (Anti-HBs) [One month after (POST) Dose 3.]

   A seroprotected subject was a subject with anti-HBs antibody concentrations ≥ 10 milli-International Units ler milliliter (mIU/mL). A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Some of the available blood samples initially tested with ELISA were re-tested using the new assay, CLIA.

4. Number of Subjects With Anti-HBs Antibody Concentrations ≥100 mIU/mL [One month after (POST) Dose 3.]

   The testing was done using the Enzyme-Linked Immunosorbent assay (ELISA) assay.

5. Anti-HBs Antibody Concentrations [One month after (POST) Dose 3.]

   Anti-HBs antibody concentrations were assessed by Enzyme-Linked Immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs).

6. Number of Subjects With Unsolicited Adverse Events (AEs) [During the 31 day (Days 0-30) post vaccination]

   An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the 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.

7. Number of Subjects With Serious Adverse Events (SAEs) [During the entire study period up to Last subject last visit on 03/12/2013]

   Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Weeks to 12 Weeks
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

• A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.

• Born after a gestation period of 36 to 42 weeks inclusive.

• Healthy subjects as established by medical history before entering into the study.

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

Exclusion Criteria:

• Use of any investigational or non-registered product within 30 days preceding the first dose of study vaccine, or planned use during the study period.

• Chronic administration of immunosuppressants or other immune-modifying drugs from birth until first primary vaccination dose..

• Administration of immunoglobulins and/or any blood products since birth or planned administration 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.

• Major congenital defects or serious chronic illness.

• Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Hib vaccination or disease.

• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.

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

• The following condition is temporary or self limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met:

• Current febrile illness or axillary temperature of ≥ 37.5 ºC or other moderate to severe illness within 24 hours of study vaccine administration.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Edmonton	Alberta	Canada	T5M 3Z7
2	GSK Investigational Site	Vancouver	British Columbia	Canada	V5Z 4H4
3	GSK Investigational Site	Truro	Nova Scotia	Canada	B2N 1L2

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

• Scheifele DW, Ferguson M, Predy G, Dawar M, Assudani D, Kuriyakose S, Van Der Meeren O, Han HH. Immunogenicity and safety of 3-dose primary vaccination with combined DTPa-HBV-IPV/Hib vaccine in Canadian Aboriginal and non-Aboriginal infants. Vaccine. 2015 Apr 15;33(16):1897-900. doi: 10.1016/j.vaccine.2015.02.015. Epub 2015 Feb 18.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00753649
• Other Study ID Numbers: 103506; 2013-003428-34
• First Posted: Sep 16, 2008
• Last Update Posted: Nov 27, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: Infant; First nation; Aboriginal; Canada
• Additional relevant MeSH terms: Hepatitis B; Diphtheria; Poliomyelitis

Study Results

Participant Flow

Recruitment Details	Study started on 23-Sep-2008 and enrolled 224 subjects from Canada.
Pre-assignment Detail	During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

Arm/Group Title	Infanrix Hexa Aboriginal Group	Infanrix Hexa Non-Aboriginal Group
Arm/Group Description	Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.	Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
Period Title: Overall Study
STARTED	112	112
COMPLETED	105	112
NOT COMPLETED	7	0

Baseline Characteristics

Arm/Group Title	Infanrix Hexa Aboriginal Group	Infanrix Hexa Non-Aboriginal Group	Total
Arm/Group Description	Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.	Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.	Total of all reporting groups
Overall Participants	112	112	224
Age (Weeks) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Weeks]	9.3 (1.38)	9.2 (1.3)	9.25 (1.34)
Sex: Female, Male (Count of Participants)
Female	62 55.4%	52 46.4%	114 50.9%
Male	50 44.6%	60 53.6%	110 49.1%

Outcome Measures

1. Primary Outcome

Title	Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (Anti-PRP)
Description	A seroprotected subject was a subject whose anti-PRP antibody concentration was greater or equal to (≥) 0.15 microgram per milliliter (µg/mL).
Time Frame	One month after (POST) Dose 3.

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received 3 doses of Infanrix Hexa vaccine and for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Infanrix Hexa Aboriginal Group	Infanrix Hexa Non-Aboriginal Group
Arm/Group Description	Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.	Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
Measure Participants	94	107
Number [Subjects]	92	106

2. Secondary Outcome

Title	Number of Subjects With Anti-PRP Antibody Concentrations ≥1µg/mL
Description	For this assay, 1 μg/mL was considered as the seropositivity cut-off.
Time Frame	One month after (POST) Dose 3.

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received 3 doses of Infanrix Hexa vaccine and for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Infanrix Hexa Aboriginal Group	Infanrix Hexa Non-Aboriginal Group
Arm/Group Description	Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.	Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
Measure Participants	94	107
Number [Subjects]	83	91

3. Secondary Outcome

Title	Anti-PRP Antibody Concentrations
Description	Anti-PRP antibody concentrations were presented as Geometric mean Concentrations (GMC), expressed as micrograms per milliliter (μg/mL).
Time Frame	One month after (POST) Dose 3.

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received 3 doses of Infanrix Hexa vaccine and for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Infanrix Hexa Aboriginal Group	Infanrix Hexa Non-Aboriginal Group
Arm/Group Description	Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.	Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
Measure Participants	94	107
Geometric Mean (95% Confidence Interval) [µg/mL]	6.123	3.51

4. Secondary Outcome

Title	Number of Seroprotected Subjects Against Hepatitis B (Anti-HBs)
Description	A seroprotected subject was a subject with anti-HBs antibody concentrations ≥ 10 milli-International Units ler milliliter (mIU/mL). A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Some of the available blood samples initially tested with ELISA were re-tested using the new assay, CLIA.
Time Frame	One month after (POST) Dose 3.

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received 3 doses of Infanrix Hexa vaccine and for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Infanrix Hexa Aboriginal Group	Infanrix Hexa Non-Aboriginal Group
Arm/Group Description	Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.	Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
Measure Participants	91	103
Number [Subjects]	91	103

5. Secondary Outcome

Title	Number of Subjects With Anti-HBs Antibody Concentrations ≥100 mIU/mL
Description	The testing was done using the Enzyme-Linked Immunosorbent assay (ELISA) assay.
Time Frame	One month after (POST) Dose 3.

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received 3 doses of Infanrix Hexa vaccine and for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Infanrix Hexa Aboriginal Group	Infanrix Hexa Non-Aboriginal Group
Arm/Group Description	Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.	Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
Measure Participants	91	103
Number [Subjects]	89	100

6. Secondary Outcome

Title	Anti-HBs Antibody Concentrations
Description	Anti-HBs antibody concentrations were assessed by Enzyme-Linked Immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs).
Time Frame	One month after (POST) Dose 3.

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received 3 doses of Infanrix Hexa vaccine and for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Infanrix Hexa Aboriginal Group	Infanrix Hexa Non-Aboriginal Group
Arm/Group Description	Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.	Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
Measure Participants	91	103
Geometric Mean (95% Confidence Interval) [mIU/mL]	1797.9	1544.4

7. Secondary Outcome

Title	Number of Subjects With Unsolicited Adverse Events (AEs)
Description	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the 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.
Time Frame	During the 31 day (Days 0-30) post vaccination

Outcome Measure Data

Analysis Population Description

The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one dose of Infanrix hexa administration documented.

Arm/Group Title	Infanrix Hexa Aboriginal Group	Infanrix Hexa Non-Aboriginal Group
Arm/Group Description	Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.	Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
Measure Participants	112	112
Number [Subjects]	26	19

8. Secondary Outcome

Title	Number of Subjects With Serious Adverse Events (SAEs)
Description	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame	During the entire study period up to Last subject last visit on 03/12/2013

Outcome Measure Data

Analysis Population Description

The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one dose of Infanrix hexa administration documented.

Arm/Group Title	Infanrix Hexa Aboriginal Group	Infanrix Hexa Non-Aboriginal Group
Arm/Group Description	Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.	Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
Measure Participants	112	112
Number [Subjects]	6	0

Adverse Events

Time Frame	Unsolicited AEs during the 31-day post-vaccination period, SAEs during the entire period up to Last subject last visit on 03/12/2013.
Adverse Event Reporting Description	During this study, no solicited adverse events were collected, therefore none are reported.
Arm/Group Title	Infanrix Hexa Aboriginal Group		Infanrix Hexa Non-Aboriginal Group
Arm/Group Description	Subjects of aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.		Subjects of non-aboriginal origins who received 3 doses of Infanrix Hexa vaccine at 2, 4, and 6 months of age, administered as an intramuscular injection into the right side of the thigh. Subjects also received two doses of Rotarix vaccine at 2 and 4 months of age (administered orally), a pneumococcal conjugate vaccine, meningococcal serogroup C conjugate vaccine and an influenza vaccine according to the recommended provincial infant immunisation schedules.
All Cause Mortality
	Infanrix Hexa Aboriginal Group		Infanrix Hexa Non-Aboriginal Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Infanrix Hexa Aboriginal Group		Infanrix Hexa Non-Aboriginal Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/112 (5.4%)		0/112 (0%)
General disorders
Pyrexia	1/112 (0.9%)	1	0/112 (0%)	0
Infections and infestations
Bronchiolitis	1/112 (0.9%)	1	0/112 (0%)	0
Pneumonia bacterial	1/112 (0.9%)	1	0/112 (0%)	0
Respiratory syncytial virus infection	1/112 (0.9%)	1	0/112 (0%)	0
Nervous system disorders
Convulsion	2/112 (1.8%)	2	0/112 (0%)	0
Febrile convulsion	1/112 (0.9%)	1	0/112 (0%)	0
Other (Not Including Serious) Adverse Events
	Infanrix Hexa Aboriginal Group		Infanrix Hexa Non-Aboriginal Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/112 (5.4%)		0/112 (0%)
General disorders
Pyrexia	6/112 (5.4%)	6	0/112 (0%)	0

Limitations/Caveats

None reported.

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.