Trial Outcomes & Findings for Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants (NCT NCT00753649)
NCT ID: NCT00753649
Last Updated: 2019-11-27
Results Overview
A seroprotected subject was a subject whose anti-PRP antibody concentration was greater or equal to (≥) 0.15 microgram per milliliter (µg/mL).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
224 participants
Primary outcome timeframe
One month after (POST) Dose 3.
Results posted on
2019-11-27
Participant Flow
Study started on 23-Sep-2008 and enrolled 224 subjects from Canada.
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participant milestones
| Measure |
Infanrix Hexa Aboriginal Group
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.
|
Infanrix Hexa Non-Aboriginal Group
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.
|
|---|---|---|
|
Overall Study
STARTED
|
112
|
112
|
|
Overall Study
COMPLETED
|
105
|
112
|
|
Overall Study
NOT COMPLETED
|
7
|
0
|
Reasons for withdrawal
| Measure |
Infanrix Hexa Aboriginal Group
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.
|
Infanrix Hexa Non-Aboriginal Group
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.
|
|---|---|---|
|
Overall Study
Migrated/moved from study area
|
1
|
0
|
|
Overall Study
Lost to follow-up-incomplete vaccination
|
3
|
0
|
|
Overall Study
Lost to follow-up-complete vaccination
|
1
|
0
|
|
Overall Study
Protocol Violation
|
2
|
0
|
Baseline Characteristics
Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants
Baseline characteristics by cohort
| Measure |
Infanrix Hexa Aboriginal Group
n=112 Participants
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.
|
Infanrix Hexa Non-Aboriginal Group
n=112 Participants
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
n=224 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.3 Weeks
STANDARD_DEVIATION 1.38 • n=99 Participants
|
9.2 Weeks
STANDARD_DEVIATION 1.3 • n=107 Participants
|
9.25 Weeks
STANDARD_DEVIATION 1.34 • n=206 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
114 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
110 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: One month after (POST) Dose 3.Population: 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.
A seroprotected subject was a subject whose anti-PRP antibody concentration was greater or equal to (≥) 0.15 microgram per milliliter (µg/mL).
Outcome measures
| Measure |
Infanrix Hexa Aboriginal Group
n=94 Participants
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.
|
Infanrix Hexa Non-Aboriginal Group
n=107 Participants
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.
|
|---|---|---|
|
Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (Anti-PRP)
|
92 Subjects
|
106 Subjects
|
SECONDARY outcome
Timeframe: One month after (POST) Dose 3.Population: 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.
For this assay, 1 μg/mL was considered as the seropositivity cut-off.
Outcome measures
| Measure |
Infanrix Hexa Aboriginal Group
n=94 Participants
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.
|
Infanrix Hexa Non-Aboriginal Group
n=107 Participants
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.
|
|---|---|---|
|
Number of Subjects With Anti-PRP Antibody Concentrations ≥1µg/mL
|
83 Subjects
|
91 Subjects
|
SECONDARY outcome
Timeframe: One month after (POST) Dose 3.Population: 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.
Anti-PRP antibody concentrations were presented as Geometric mean Concentrations (GMC), expressed as micrograms per milliliter (μg/mL).
Outcome measures
| Measure |
Infanrix Hexa Aboriginal Group
n=94 Participants
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.
|
Infanrix Hexa Non-Aboriginal Group
n=107 Participants
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.
|
|---|---|---|
|
Anti-PRP Antibody Concentrations
|
6.123 µg/mL
Interval 4.498 to 8.334
|
3.51 µg/mL
Interval 2.745 to 4.488
|
SECONDARY outcome
Timeframe: One month after (POST) Dose 3.Population: 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.
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.
Outcome measures
| Measure |
Infanrix Hexa Aboriginal Group
n=91 Participants
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.
|
Infanrix Hexa Non-Aboriginal Group
n=103 Participants
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.
|
|---|---|---|
|
Number of Seroprotected Subjects Against Hepatitis B (Anti-HBs)
|
91 Subjects
|
103 Subjects
|
SECONDARY outcome
Timeframe: One month after (POST) Dose 3.Population: 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.
The testing was done using the Enzyme-Linked Immunosorbent assay (ELISA) assay.
Outcome measures
| Measure |
Infanrix Hexa Aboriginal Group
n=91 Participants
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.
|
Infanrix Hexa Non-Aboriginal Group
n=103 Participants
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.
|
|---|---|---|
|
Number of Subjects With Anti-HBs Antibody Concentrations ≥100 mIU/mL
|
89 Subjects
|
100 Subjects
|
SECONDARY outcome
Timeframe: One month after (POST) Dose 3.Population: 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.
Anti-HBs antibody concentrations were assessed by Enzyme-Linked Immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs).
Outcome measures
| Measure |
Infanrix Hexa Aboriginal Group
n=91 Participants
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.
|
Infanrix Hexa Non-Aboriginal Group
n=103 Participants
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.
|
|---|---|---|
|
Anti-HBs Antibody Concentrations
|
1797.9 mIU/mL
Interval 1375.1 to 2350.7
|
1544.4 mIU/mL
Interval 1210.4 to 1970.5
|
SECONDARY outcome
Timeframe: During the 31 day (Days 0-30) post vaccinationPopulation: The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one dose of Infanrix hexa administration documented.
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.
Outcome measures
| Measure |
Infanrix Hexa Aboriginal Group
n=112 Participants
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.
|
Infanrix Hexa Non-Aboriginal Group
n=112 Participants
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.
|
|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
|
26 Subjects
|
19 Subjects
|
SECONDARY outcome
Timeframe: During the entire study period up to Last subject last visit on 03/12/2013Population: The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one dose of Infanrix hexa administration documented.
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.
Outcome measures
| Measure |
Infanrix Hexa Aboriginal Group
n=112 Participants
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.
|
Infanrix Hexa Non-Aboriginal Group
n=112 Participants
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.
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
6 Subjects
|
0 Subjects
|
Adverse Events
Infanrix Hexa Aboriginal Group
Serious events: 6 serious events
Other events: 6 other events
Deaths: 0 deaths
Infanrix Hexa Non-Aboriginal Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Infanrix Hexa Aboriginal Group
n=112 participants at risk
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.
|
Infanrix Hexa Non-Aboriginal Group
n=112 participants at risk
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.
|
|---|---|---|
|
Nervous system disorders
Convulsion
|
1.8%
2/112 • Number of events 2 • Unsolicited AEs during the 31-day post-vaccination period, SAEs during the entire period up to Last subject last visit on 03/12/2013.
During this study, no solicited adverse events were collected, therefore none are reported.
|
0.00%
0/112 • Unsolicited AEs during the 31-day post-vaccination period, SAEs during the entire period up to Last subject last visit on 03/12/2013.
During this study, no solicited adverse events were collected, therefore none are reported.
|
|
Nervous system disorders
Febrile convulsion
|
0.89%
1/112 • Number of events 1 • Unsolicited AEs during the 31-day post-vaccination period, SAEs during the entire period up to Last subject last visit on 03/12/2013.
During this study, no solicited adverse events were collected, therefore none are reported.
|
0.00%
0/112 • Unsolicited AEs during the 31-day post-vaccination period, SAEs during the entire period up to Last subject last visit on 03/12/2013.
During this study, no solicited adverse events were collected, therefore none are reported.
|
|
General disorders
Pyrexia
|
0.89%
1/112 • Number of events 1 • Unsolicited AEs during the 31-day post-vaccination period, SAEs during the entire period up to Last subject last visit on 03/12/2013.
During this study, no solicited adverse events were collected, therefore none are reported.
|
0.00%
0/112 • Unsolicited AEs during the 31-day post-vaccination period, SAEs during the entire period up to Last subject last visit on 03/12/2013.
During this study, no solicited adverse events were collected, therefore none are reported.
|
|
Infections and infestations
Bronchiolitis
|
0.89%
1/112 • Number of events 1 • Unsolicited AEs during the 31-day post-vaccination period, SAEs during the entire period up to Last subject last visit on 03/12/2013.
During this study, no solicited adverse events were collected, therefore none are reported.
|
0.00%
0/112 • Unsolicited AEs during the 31-day post-vaccination period, SAEs during the entire period up to Last subject last visit on 03/12/2013.
During this study, no solicited adverse events were collected, therefore none are reported.
|
|
Infections and infestations
Pneumonia bacterial
|
0.89%
1/112 • Number of events 1 • Unsolicited AEs during the 31-day post-vaccination period, SAEs during the entire period up to Last subject last visit on 03/12/2013.
During this study, no solicited adverse events were collected, therefore none are reported.
|
0.00%
0/112 • Unsolicited AEs during the 31-day post-vaccination period, SAEs during the entire period up to Last subject last visit on 03/12/2013.
During this study, no solicited adverse events were collected, therefore none are reported.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.89%
1/112 • Number of events 1 • Unsolicited AEs during the 31-day post-vaccination period, SAEs during the entire period up to Last subject last visit on 03/12/2013.
During this study, no solicited adverse events were collected, therefore none are reported.
|
0.00%
0/112 • Unsolicited AEs during the 31-day post-vaccination period, SAEs during the entire period up to Last subject last visit on 03/12/2013.
During this study, no solicited adverse events were collected, therefore none are reported.
|
Other adverse events
| Measure |
Infanrix Hexa Aboriginal Group
n=112 participants at risk
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.
|
Infanrix Hexa Non-Aboriginal Group
n=112 participants at risk
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.
|
|---|---|---|
|
General disorders
Pyrexia
|
5.4%
6/112 • Number of events 6 • Unsolicited AEs during the 31-day post-vaccination period, SAEs during the entire period up to Last subject last visit on 03/12/2013.
During this study, no solicited adverse events were collected, therefore none are reported.
|
0.00%
0/112 • Unsolicited AEs during the 31-day post-vaccination period, SAEs during the entire period up to Last subject last visit on 03/12/2013.
During this study, no solicited adverse events were collected, therefore none are reported.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER