Trial Outcomes & Findings for Immunogenicity and Safety of GSK Biologicals' Infanrix/Hib in Children (NCT NCT00696423)
NCT ID: NCT00696423
Last Updated: 2018-06-06
Results Overview
Geometric mean concentrations are given in microgram per milliliter (μg/mL).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
467 participants
Primary outcome timeframe
One month after booster vaccination
Results posted on
2018-06-06
Participant Flow
Participant milestones
| Measure |
Infanrix/Hib Single Injection Group
Subjects received 1 dose of Infanrix extemporaneously mixed with Hiberix.
|
Infanrix + Hiberix Separate Injection Group
Subjects received two separate injections, one of Infanrix and one of Hiberix.
|
|---|---|---|
|
Overall Study
STARTED
|
244
|
223
|
|
Overall Study
COMPLETED
|
244
|
218
|
|
Overall Study
NOT COMPLETED
|
0
|
5
|
Reasons for withdrawal
| Measure |
Infanrix/Hib Single Injection Group
Subjects received 1 dose of Infanrix extemporaneously mixed with Hiberix.
|
Infanrix + Hiberix Separate Injection Group
Subjects received two separate injections, one of Infanrix and one of Hiberix.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
5
|
Baseline Characteristics
Immunogenicity and Safety of GSK Biologicals' Infanrix/Hib in Children
Baseline characteristics by cohort
| Measure |
Infanrix/Hib Single Injection Group
n=244 Participants
Subjects received 1 dose of Infanrix extemporaneously mixed with Hiberix.
|
Infanrix + Hiberix Separate Injection Group
n=223 Participants
Subjects received two separate injections, one of Infanrix and one of Hiberix.
|
Total
n=467 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
19.2 months
STANDARD_DEVIATION 0.79 • n=5 Participants
|
19.2 months
STANDARD_DEVIATION 0.75 • n=7 Participants
|
19.2 months
STANDARD_DEVIATION 0.77 • n=5 Participants
|
|
Sex: Female, Male
Female
|
113 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
224 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
131 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
243 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One month after booster vaccinationPopulation: Analysis was performed on the According To Protocol (ATP) cohort for immunogenicity.
Geometric mean concentrations are given in microgram per milliliter (μg/mL).
Outcome measures
| Measure |
Infanrix/Hib Single Injection Group
n=238 Participants
Subjects received 1 dose of Infanrix extemporaneously mixed with Hiberix.
|
Infanrix + Hiberix Separate Injection Group
n=216 Participants
Subjects received two separate injections, one of Infanrix and one of Hiberix.
|
|---|---|---|
|
Anti-polyribosyl-ribitol-phosphate (PRP) Antibody Concentrations
|
34.428 μg/mL
Interval 29.452 to 40.244
|
132.075 μg/mL
Interval 112.563 to 154.97
|
PRIMARY outcome
Timeframe: One month after booster vaccinationPopulation: Analysis was performed on the ATP cohort for immunogenicity.
Geometric mean concentrations are given in international Unit per milliliter (IU/mL).
Outcome measures
| Measure |
Infanrix/Hib Single Injection Group
n=237 Participants
Subjects received 1 dose of Infanrix extemporaneously mixed with Hiberix.
|
Infanrix + Hiberix Separate Injection Group
n=214 Participants
Subjects received two separate injections, one of Infanrix and one of Hiberix.
|
|---|---|---|
|
Anti-diphtheria Toxoid Antibody Concentrations
|
0.945 IU/mL
Interval 0.905 to 0.987
|
0.926 IU/mL
Interval 0.887 to 0.966
|
PRIMARY outcome
Timeframe: One month after booster vaccinationPopulation: Analysis was performed on the ATP cohort for immunogenicity.
Geometric mean concentrations are given in IU/mL.
Outcome measures
| Measure |
Infanrix/Hib Single Injection Group
n=237 Participants
Subjects received 1 dose of Infanrix extemporaneously mixed with Hiberix.
|
Infanrix + Hiberix Separate Injection Group
n=214 Participants
Subjects received two separate injections, one of Infanrix and one of Hiberix.
|
|---|---|---|
|
Anti-tetanus Toxoid Antibody Concentrations
|
7.455 IU/mL
Interval 6.881 to 8.077
|
10.104 IU/mL
Interval 9.08 to 11.242
|
PRIMARY outcome
Timeframe: One month after booster vaccinationPopulation: Analysis was performed on the ATP cohort for immunogenicity.
Geometric mean concentrations are given in Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).
Outcome measures
| Measure |
Infanrix/Hib Single Injection Group
n=239 Participants
Subjects received 1 dose of Infanrix extemporaneously mixed with Hiberix.
|
Infanrix + Hiberix Separate Injection Group
n=216 Participants
Subjects received two separate injections, one of Infanrix and one of Hiberix.
|
|---|---|---|
|
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations
Anti-PT
|
52.2 EL.U/mL
Interval 48.1 to 56.7
|
55.8 EL.U/mL
Interval 51.7 to 60.3
|
|
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations
Anti-FHA
|
93.3 EL.U/mL
Interval 82.6 to 105.4
|
92.8 EL.U/mL
Interval 83.3 to 103.4
|
|
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations
Anti-PRN
|
235.9 EL.U/mL
Interval 208.7 to 266.5
|
241.6 EL.U/mL
Interval 213.6 to 273.2
|
PRIMARY outcome
Timeframe: One month after booster vaccinationPopulation: Analysis was performed on the ATP cohort for immunogenicity.
Assay cut-offs indicating seroprotection or seropositivity for the different antigens were the following: anti-PRP antibody concentrations ≥ 0.15 µg/mL, anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/mL, anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 20 EL.U/mL.
Outcome measures
| Measure |
Infanrix/Hib Single Injection Group
n=239 Participants
Subjects received 1 dose of Infanrix extemporaneously mixed with Hiberix.
|
Infanrix + Hiberix Separate Injection Group
n=216 Participants
Subjects received two separate injections, one of Infanrix and one of Hiberix.
|
|---|---|---|
|
The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies
Seroprotection against PRP (n=238, 216)
|
238 subjects
|
216 subjects
|
|
The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies
Seroprotection against diphtheria (n=237, 214)
|
237 subjects
|
214 subjects
|
|
The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies
Seroprotection against tetanus (n=237, 214)
|
237 subjects
|
214 subjects
|
|
The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies
Seropositivity for anti-PT (n=239, 216)
|
226 subjects
|
213 subjects
|
|
The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies
Seropositivity for anti-FHA (n=239, 216)
|
238 subjects
|
216 subjects
|
|
The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies
Seropositivity for anti-PRN (n=239, 216)
|
239 subjects
|
215 subjects
|
SECONDARY outcome
Timeframe: Before booster vaccinationPopulation: Analysis was performed on the ATP cohort for immunogenicity.
Geometric mean concentrations are given in μg/mL.
Outcome measures
| Measure |
Infanrix/Hib Single Injection Group
n=237 Participants
Subjects received 1 dose of Infanrix extemporaneously mixed with Hiberix.
|
Infanrix + Hiberix Separate Injection Group
n=216 Participants
Subjects received two separate injections, one of Infanrix and one of Hiberix.
|
|---|---|---|
|
Anti-PRP Antibody Concentrations
|
1.240 μg/mL
Interval 1.085 to 1.418
|
2.461 μg/mL
Interval 2.136 to 2.837
|
SECONDARY outcome
Timeframe: Before booster vaccinationPopulation: Analysis was performed on the ATP cohort for immunogenicity.
Geometric mean concentrations are given in IU/mL.
Outcome measures
| Measure |
Infanrix/Hib Single Injection Group
n=237 Participants
Subjects received 1 dose of Infanrix extemporaneously mixed with Hiberix.
|
Infanrix + Hiberix Separate Injection Group
n=214 Participants
Subjects received two separate injections, one of Infanrix and one of Hiberix.
|
|---|---|---|
|
Anti-diphtheria Toxoid Antibody Concentrations
|
0.055 IU/mL
Interval 0.053 to 0.058
|
0.054 IU/mL
Interval 0.052 to 0.057
|
SECONDARY outcome
Timeframe: Before booster vaccinationPopulation: Analysis was performed on the ATP cohort for immunogenicity.
Geometric mean concentrations are given in IU/mL.
Outcome measures
| Measure |
Infanrix/Hib Single Injection Group
n=237 Participants
Subjects received 1 dose of Infanrix extemporaneously mixed with Hiberix.
|
Infanrix + Hiberix Separate Injection Group
n=214 Participants
Subjects received two separate injections, one of Infanrix and one of Hiberix.
|
|---|---|---|
|
Anti-tetanus Toxoid Antibody Concentrations
|
0.219 IU/mL
Interval 0.195 to 0.247
|
0.311 IU/mL
Interval 0.274 to 0.353
|
SECONDARY outcome
Timeframe: Before booster vaccinationPopulation: Analysis was performed on the ATP cohort for immunogenicity.
Geometric mean concentrations are given in EL.U/mL.
Outcome measures
| Measure |
Infanrix/Hib Single Injection Group
n=239 Participants
Subjects received 1 dose of Infanrix extemporaneously mixed with Hiberix.
|
Infanrix + Hiberix Separate Injection Group
n=216 Participants
Subjects received two separate injections, one of Infanrix and one of Hiberix.
|
|---|---|---|
|
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Anti-PT
|
10.0 EL.U/mL
Interval 10.0 to 10.0
|
10.0 EL.U/mL
Interval 10.0 to 10.1
|
|
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Anti-FHA
|
10.1 EL.U/mL
Interval 10.0 to 10.2
|
10.3 EL.U/mL
Interval 9.9 to 10.7
|
|
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Anti-PRN
|
10.2 EL.U/mL
Interval 10.0 to 10.4
|
10.3 EL.U/mL
Interval 10.0 to 10.5
|
SECONDARY outcome
Timeframe: Before booster vaccinationPopulation: Analysis was performed on the ATP cohort for immunogenicity.
Assay cut-offs indicating seroprotection or seropositivity for the different antigens were the following: anti-PRP antibody concentrations ≥ 0.15 µg/mL, anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/mL, anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 20 EL.U/mL.
Outcome measures
| Measure |
Infanrix/Hib Single Injection Group
n=239 Participants
Subjects received 1 dose of Infanrix extemporaneously mixed with Hiberix.
|
Infanrix + Hiberix Separate Injection Group
n=216 Participants
Subjects received two separate injections, one of Infanrix and one of Hiberix.
|
|---|---|---|
|
The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies
Seroprotection against PRP (n= 237, 216)
|
236 subjects
|
216 subjects
|
|
The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies
Seroprotection against diphtheria (n= 237, 214)
|
21 subjects
|
16 subjects
|
|
The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies
Seroprotection against tetanus (n= 237, 214)
|
209 subjects
|
198 subjects
|
|
The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies
Seropositivity for anti-PT (n= 239, 216)
|
0 subjects
|
1 subjects
|
|
The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies
Seropositivity for anti-FHA (n= 239, 216)
|
2 subjects
|
3 subjects
|
|
The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies
Seropositivity for anti-PRN (n= 239, 216)
|
3 subjects
|
4 subjects
|
SECONDARY outcome
Timeframe: During the 4-day follow-up period after booster vaccinationPopulation: Analysis was performed on subjects from the Total Vaccinated Cohort with a documented dose.
Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability, and loss of appetite.
Outcome measures
| Measure |
Infanrix/Hib Single Injection Group
n=244 Participants
Subjects received 1 dose of Infanrix extemporaneously mixed with Hiberix.
|
Infanrix + Hiberix Separate Injection Group
n=220 Participants
Subjects received two separate injections, one of Infanrix and one of Hiberix.
|
|---|---|---|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Pain
|
26 subjects
|
26 subjects
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Redness
|
16 subjects
|
8 subjects
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Swelling
|
9 subjects
|
1 subjects
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Drowsiness
|
26 subjects
|
20 subjects
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Fever
|
73 subjects
|
93 subjects
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Irritability
|
43 subjects
|
46 subjects
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Loss of appetite
|
40 subjects
|
39 subjects
|
SECONDARY outcome
Timeframe: During the 31-day follow-up period after booster vaccinationAn AE is 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.
Outcome measures
| Measure |
Infanrix/Hib Single Injection Group
n=244 Participants
Subjects received 1 dose of Infanrix extemporaneously mixed with Hiberix.
|
Infanrix + Hiberix Separate Injection Group
n=223 Participants
Subjects received two separate injections, one of Infanrix and one of Hiberix.
|
|---|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events (AE)
|
66 subjects
|
56 subjects
|
SECONDARY outcome
Timeframe: During the 31-day follow-up period after booster vaccinationAn SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in isability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Outcome measures
| Measure |
Infanrix/Hib Single Injection Group
n=244 Participants
Subjects received 1 dose of Infanrix extemporaneously mixed with Hiberix.
|
Infanrix + Hiberix Separate Injection Group
n=223 Participants
Subjects received two separate injections, one of Infanrix and one of Hiberix.
|
|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events (SAE)
|
1 subjects
|
3 subjects
|
Adverse Events
Infanrix/Hib Single Injection Group
Serious events: 1 serious events
Other events: 133 other events
Deaths: 0 deaths
Infanrix + Hiberix Separate Injection Group
Serious events: 3 serious events
Other events: 127 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Infanrix/Hib Single Injection Group
n=244 participants at risk
Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
|
Infanrix + Hiberix Separate Injection Group
n=223 participants at risk
Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
|
|---|---|---|
|
Infections and infestations
Bronchopneumonia
|
0.42%
1/240
|
0.90%
2/223
|
|
Infections and infestations
Bronchitis
|
0.00%
0/240
|
0.45%
1/223
|
Other adverse events
| Measure |
Infanrix/Hib Single Injection Group
n=244 participants at risk
Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
|
Infanrix + Hiberix Separate Injection Group
n=223 participants at risk
Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
|
|---|---|---|
|
General disorders
Pain at injection site
|
10.7%
26/244
|
11.7%
26/223
|
|
General disorders
Redness at injection site
|
6.6%
16/244
|
3.6%
8/223
|
|
General disorders
Drowsiness
|
10.7%
26/244
|
9.0%
20/223
|
|
General disorders
Fever
|
29.9%
73/244
|
41.7%
93/223
|
|
General disorders
Irritability
|
17.6%
43/244
|
20.6%
46/223
|
|
General disorders
Loss of appetite
|
16.4%
40/244
|
17.5%
39/223
|
|
Infections and infestations
Nasopharyngitis
|
16.0%
39/244
|
10.8%
24/223
|
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