Trial Outcomes & Findings for Study to Evaluate Antibody Persistence in Children Previously Vaccinated With Infanrix Hexa™ or Infanrix-IPV/Hib™ (NCT NCT01358825)
NCT ID: NCT01358825
Last Updated: 2021-01-19
Results Overview
A seroprotected subject is a subject with anti-D/anti-T antibody concentrations greater than (≥) or equal to 0.1 international units per milliliter (IU/mL)
COMPLETED
PHASE4
58 participants
At Day 0
2021-01-19
Participant Flow
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 Group
Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
|
Infanrix-IPV/Hib Group
Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
46
|
|
Overall Study
COMPLETED
|
12
|
45
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Infanrix Hexa Group
Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
|
Infanrix-IPV/Hib Group
Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
|
|---|---|---|
|
Overall Study
Blood sample not drawn
|
0
|
1
|
Baseline Characteristics
Study to Evaluate Antibody Persistence in Children Previously Vaccinated With Infanrix Hexa™ or Infanrix-IPV/Hib™
Baseline characteristics by cohort
| Measure |
Infanrix Hexa Group
n=12 Participants
Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
|
Infanrix-IPV/Hib Group
n=46 Participants
Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
5.0 Years
STANDARD_DEVIATION 0.0 • n=99 Participants
|
5.0 Years
STANDARD_DEVIATION 0.0 • n=107 Participants
|
5.0 Years
STANDARD_DEVIATION 0.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: At Day 0Population: The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.
A seroprotected subject is a subject with anti-D/anti-T antibody concentrations greater than (≥) or equal to 0.1 international units per milliliter (IU/mL)
Outcome measures
| Measure |
Infanrix Hexa Group
n=12 Participants
Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
|
Infanrix-IPV/Hib Group
n=45 Participants
Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
|
|---|---|---|
|
Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T).
Anti-D
|
7 Participants
|
28 Participants
|
|
Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T).
Anti-T
|
10 Participants
|
34 Participants
|
PRIMARY outcome
Timeframe: At Day 0Population: The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.
Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL).
Outcome measures
| Measure |
Infanrix Hexa Group
n=12 Participants
Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
|
Infanrix-IPV/Hib Group
n=45 Participants
Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
|
|---|---|---|
|
Concentrations of Antibodies Against Anti-D and Anti-T
Anti-D
|
0.13 IU/mL
Interval 0.072 to 0.235
|
0.196 IU/mL
Interval 0.114 to 0.338
|
|
Concentrations of Antibodies Against Anti-D and Anti-T
Anti-T
|
0.29 IU/mL
Interval 0.135 to 0.624
|
0.352 IU/mL
Interval 0.207 to 0.599
|
PRIMARY outcome
Timeframe: At Day 0Population: The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.
Cut-off values assessed were greater than or equal to 5 ELISA units per millilitre (EL.U/mL) in the sera of subjects seronegative before vaccination.
Outcome measures
| Measure |
Infanrix Hexa Group
n=12 Participants
Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
|
Infanrix-IPV/Hib Group
n=45 Participants
Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
|
|---|---|---|
|
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Antifilamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations ≥5 ELISA Units Per Milliliter (EL.U/mL).
Anti-PT
|
0 Participants
|
9 Participants
|
|
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Antifilamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations ≥5 ELISA Units Per Milliliter (EL.U/mL).
Anti-FHA
|
12 Participants
|
41 Participants
|
|
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Antifilamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations ≥5 ELISA Units Per Milliliter (EL.U/mL).
Anti-PRN
|
8 Participants
|
34 Participants
|
PRIMARY outcome
Timeframe: At Day 0Population: The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.
Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL).
Outcome measures
| Measure |
Infanrix Hexa Group
n=12 Participants
Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
|
Infanrix-IPV/Hib Group
n=45 Participants
Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
|
|---|---|---|
|
Concentrations of Antibodies Against Anti-PT, Anti-FHA and Anti-PRN.
Anti-PRN
|
6.2 EL.U/mL
Interval 3.9 to 9.9
|
11.9 EL.U/mL
Interval 8.4 to 16.8
|
|
Concentrations of Antibodies Against Anti-PT, Anti-FHA and Anti-PRN.
Anti-PT
|
2.5 EL.U/mL
Interval 2.5 to 2.5
|
4.2 EL.U/mL
Interval 2.9 to 6.0
|
|
Concentrations of Antibodies Against Anti-PT, Anti-FHA and Anti-PRN.
Anti-FHA
|
32.6 EL.U/mL
Interval 11.5 to 92.5
|
50.7 EL.U/mL
Interval 30.6 to 84.1
|
PRIMARY outcome
Timeframe: At Day 0Population: The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.
Seroprotection = anti-HBs antibody concentration ≥ 10 milli-international units per milliliter (mIU/mL).
Outcome measures
| Measure |
Infanrix Hexa Group
n=12 Participants
Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
|
Infanrix-IPV/Hib Group
Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
|
|---|---|---|
|
Number of Seroprotected Subjects Against Anti-hepatitis B Surface Antigen (Anti-HBs).
|
5 Participants
|
—
|
PRIMARY outcome
Timeframe: At Day 0Population: The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.
Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL).
Outcome measures
| Measure |
Infanrix Hexa Group
n=12 Participants
Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
|
Infanrix-IPV/Hib Group
Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
|
|---|---|---|
|
Concentrations of Antibodies Against Anti-HBs.
|
9 mIU/mL
Interval 3.9 to 20.9
|
—
|
PRIMARY outcome
Timeframe: At Day 0Population: The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.
A seroprotected subject is a subject with anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (μg/mL)
Outcome measures
| Measure |
Infanrix Hexa Group
n=12 Participants
Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
|
Infanrix-IPV/Hib Group
n=45 Participants
Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
|
|---|---|---|
|
Number of Seroprotected Subjects Against Anti-polyribosyl Ribitol Phosphate (Anti-PRP).
|
10 Participants
|
40 Participants
|
PRIMARY outcome
Timeframe: At Day 0Population: The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.
Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per millilitre (μg/mL).
Outcome measures
| Measure |
Infanrix Hexa Group
n=12 Participants
Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
|
Infanrix-IPV/Hib Group
n=45 Participants
Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
|
|---|---|---|
|
Concentrations of Antibodies Against Anti-PRP.
|
0.404 μg/mL
Interval 0.22 to 0.743
|
0.886 μg/mL
Interval 0.558 to 1.407
|
PRIMARY outcome
Timeframe: During the entire study period (up to Day 46)Population: The analysis was performed on the Total Cohort, which included all subjects enrolled in the study.
Assessed SAEs 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 Group
n=12 Participants
Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
|
Infanrix-IPV/Hib Group
n=46 Participants
Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs).
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 0Population: The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.
Cut-off values assessed were greater than or equal to 6.2 milliinternational units per millilitre ( mIU/mL) in the sera of subjects seronegative before vaccination.
Outcome measures
| Measure |
Infanrix Hexa Group
n=12 Participants
Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
|
Infanrix-IPV/Hib Group
Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
|
|---|---|---|
|
Number of Subjects With Anti-HBs Antibody Concentrations ≥ 6.2 mIU/mL
|
6 Participants
|
—
|
Adverse Events
Infanrix Hexa Group
Infanrix-IPV/Hib Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
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