Trial Outcomes & Findings for Study to Assess Safety & Immunogenicity of GSK Biologicals' DTPa/Hib Vaccine vs Separate Administration of DTPa and Hib. (NCT NCT00412854)
NCT ID: NCT00412854
Last Updated: 2018-06-06
Results Overview
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations higher than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
660 participants
Primary outcome timeframe
At Month 3
Results posted on
2018-06-06
Participant Flow
Participant milestones
| Measure |
Infanrix/Hib Group
Healthy male and female infants who received Infanrix/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
|
Infanrix+Hiberix Group
Healthy male and female infants who received Infanrix and Hiberix vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
|
|---|---|---|
|
Overall Study
STARTED
|
330
|
330
|
|
Overall Study
COMPLETED
|
316
|
314
|
|
Overall Study
NOT COMPLETED
|
14
|
16
|
Reasons for withdrawal
| Measure |
Infanrix/Hib Group
Healthy male and female infants who received Infanrix/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
|
Infanrix+Hiberix Group
Healthy male and female infants who received Infanrix and Hiberix vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
|
|---|---|---|
|
Overall Study
Withdrawn due to adverse events
|
1
|
5
|
|
Overall Study
Withdrawn for other reasons
|
13
|
11
|
Baseline Characteristics
Study to Assess Safety & Immunogenicity of GSK Biologicals' DTPa/Hib Vaccine vs Separate Administration of DTPa and Hib.
Baseline characteristics by cohort
| Measure |
Infanrix/Hib Group
n=330 Participants
Healthy male and female infants who received Infanrix/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
|
Infanrix+Hiberix Group
n=330 Participants
Healthy male and female infants who received Infanrix and Hiberix vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
|
Total
n=660 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.2 Weeks
STANDARD_DEVIATION 1.12 • n=99 Participants
|
14.2 Weeks
STANDARD_DEVIATION 1.18 • n=107 Participants
|
14.2 Weeks
STANDARD_DEVIATION 1.15 • n=206 Participants
|
|
Sex: Female, Male
Female
|
149 Participants
n=99 Participants
|
167 Participants
n=107 Participants
|
316 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
181 Participants
n=99 Participants
|
163 Participants
n=107 Participants
|
344 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: At Month 3Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations higher than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Outcome measures
| Measure |
Infanrix/Hib Group
n=163 Participants
Healthy male and female infants who received Infanrix/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
|
Infanrix+Hiberix Group
n=164 Participants
Healthy male and female infants who received Infanrix and Hiberix vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
|
|---|---|---|
|
Number of Seroprotected Subjects Against Diphteria Toxoid (D) and Tetanus Toxoid (T)
Anti-D
|
162 Subjects
|
164 Subjects
|
|
Number of Seroprotected Subjects Against Diphteria Toxoid (D) and Tetanus Toxoid (T)
Anti-T
|
163 Subjects
|
164 Subjects
|
PRIMARY outcome
Timeframe: At Month 3Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
A seroprotected subject was defined as a vaccinated subject with an anti-PRP antibody concentration higher than or equal to (≥) 0.15 microgram/milliliter (µg/mL).
Outcome measures
| Measure |
Infanrix/Hib Group
n=162 Participants
Healthy male and female infants who received Infanrix/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
|
Infanrix+Hiberix Group
n=164 Participants
Healthy male and female infants who received Infanrix and Hiberix vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
|
|---|---|---|
|
Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP)
|
158 Subjects
|
164 Subjects
|
PRIMARY outcome
Timeframe: At Month 3Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
The vaccine response was defined as it follows: * for PT and FHA, an antibody concentration higher than or equal to (≥) 20 EL.U/mL at post-vaccination; * for PRN, at least a 4-fold increase in antibody concentration from pre-vaccination to post-vaccination time points.
Outcome measures
| Measure |
Infanrix/Hib Group
n=163 Participants
Healthy male and female infants who received Infanrix/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
|
Infanrix+Hiberix Group
n=164 Participants
Healthy male and female infants who received Infanrix and Hiberix vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
|
|---|---|---|
|
Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies
Anti-PT
|
163 Subjects
|
164 Subjects
|
|
Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies
Anti-FHA
|
163 Subjects
|
164 Subjects
|
|
Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies
Anti-PRN
|
159 Subjects
|
162 Subjects
|
SECONDARY outcome
Timeframe: At Month 3Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
The number of subjects with anti-PRP antibody concentrations higher than or equal to (≥) 1.0 µg/mL post primary vaccination is reported.
Outcome measures
| Measure |
Infanrix/Hib Group
n=162 Participants
Healthy male and female infants who received Infanrix/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
|
Infanrix+Hiberix Group
n=164 Participants
Healthy male and female infants who received Infanrix and Hiberix vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
|
|---|---|---|
|
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1.0 µg/mL
|
145 Subjects
|
156 Subjects
|
SECONDARY outcome
Timeframe: At Month 0 and Month 3Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International units per milliliter (IU/mL).
Outcome measures
| Measure |
Infanrix/Hib Group
n=163 Participants
Healthy male and female infants who received Infanrix/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
|
Infanrix+Hiberix Group
n=164 Participants
Healthy male and female infants who received Infanrix and Hiberix vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
|
|---|---|---|
|
Concentrations for Anti-D and Anti-T Antibodies
Anti-T (Month 0)
|
0.050 IU/mL
Interval 0.05 to 0.05
|
0.050 IU/mL
Interval 0.05 to 0.051
|
|
Concentrations for Anti-D and Anti-T Antibodies
Anti-T (Month 3)
|
2.990 IU/mL
Interval 2.858 to 3.127
|
3.214 IU/mL
Interval 3.091 to 3.341
|
|
Concentrations for Anti-D and Anti-T Antibodies
Anti-D (Month 0)
|
0.050 IU/mL
Interval 0.05 to 0.051
|
0.051 IU/mL
Interval 0.05 to 0.052
|
|
Concentrations for Anti-D and Anti-T Antibodies
Anti-D (Month 3)
|
0.545 IU/mL
Interval 0.505 to 0.588
|
0.567 IU/mL
Interval 0.53 to 0.606
|
SECONDARY outcome
Timeframe: At Month 0 and Month 3Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram/milliliter (µg/mL).
Outcome measures
| Measure |
Infanrix/Hib Group
n=163 Participants
Healthy male and female infants who received Infanrix/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
|
Infanrix+Hiberix Group
n=164 Participants
Healthy male and female infants who received Infanrix and Hiberix vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
|
|---|---|---|
|
Concentrations for Anti-PRP Antibodies
Anti-PRP, Month 0 (N=163;164)
|
0.083 µg/mL
Interval 0.076 to 0.092
|
0.083 µg/mL
Interval 0.078 to 0.088
|
|
Concentrations for Anti-PRP Antibodies
Anti-PRP, Month 3 (N=162;164)
|
3.559 µg/mL
Interval 3.003 to 4.219
|
6.120 µg/mL
Interval 5.355 to 6.995
|
SECONDARY outcome
Timeframe: At Month 3Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Anti-PT, anti-FHA and anti-PRN antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Outcome measures
| Measure |
Infanrix/Hib Group
n=163 Participants
Healthy male and female infants who received Infanrix/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
|
Infanrix+Hiberix Group
n=164 Participants
Healthy male and female infants who received Infanrix and Hiberix vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
|
|---|---|---|
|
Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies
Anti-PT
|
66.0 EL.U/mL
Interval 61.5 to 70.8
|
67.0 EL.U/mL
Interval 62.5 to 71.8
|
|
Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies
Anti-FHA
|
207.2 EL.U/mL
Interval 192.2 to 223.4
|
198.1 EL.U/mL
Interval 182.7 to 214.8
|
|
Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies
Anti-PRN
|
172.4 EL.U/mL
Interval 157.9 to 188.3
|
177.5 EL.U/mL
Interval 163.3 to 192.9
|
SECONDARY outcome
Timeframe: During the 4-day (Day 0-3) follow-up period after each vaccine dose and across dosesPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented and with the symptoms sheet filled in.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Outcome measures
| Measure |
Infanrix/Hib Group
n=323 Participants
Healthy male and female infants who received Infanrix/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
|
Infanrix+Hiberix Group
n=326 Participants
Healthy male and female infants who received Infanrix and Hiberix vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
|
|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 1 (N=323;326)
|
44 Subjects
|
46 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 1 (N=323;326)
|
2 Subjects
|
3 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 1 (N=323;326)
|
5 Subjects
|
11 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 1 (N=323;326)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 1 (N=323;326)
|
3 Subjects
|
1 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 1 (N=323;326)
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 2 (N=317;313)
|
23 Subjects
|
32 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 2 (N=317;313)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 2 (N=317;313)
|
3 Subjects
|
11 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 2 (N=317;313)
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 2 (N=317;313)
|
9 Subjects
|
7 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 2 (N=317;313)
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 3 (N=316;312)
|
19 Subjects
|
25 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 3 (N=316;312)
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 3 (N=316;312)
|
7 Subjects
|
8 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 3 (N=316;312)
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 3 (N=316;312)
|
8 Subjects
|
6 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 3 (N=316;312)
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Across doses (N=323;326)
|
59 Subjects
|
71 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Across doses (N=323;326)
|
3 Subjects
|
3 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Across doses (N=323;326)
|
14 Subjects
|
24 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Across doses (N=323;326)
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Across doses (N=323;326)
|
17 Subjects
|
13 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Across doses (N=323;326)
|
4 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: During the 4-day (Day 0-3) follow-up period after each vaccine dose and across dosesPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented and with the symptoms sheet filled in.
Assessed solicited general symptoms were drowsiness, fever \[defined as axillary temperature equal to or above (≥) 37.1 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever above (\>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
Infanrix/Hib Group
n=323 Participants
Healthy male and female infants who received Infanrix/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
|
Infanrix+Hiberix Group
n=327 Participants
Healthy male and female infants who received Infanrix and Hiberix vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
|
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness, Dose 1 (N=323;327)
|
71 Subjects
|
84 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness, Dose 1 (N=323;327)
|
0 Subjects
|
3 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness, Dose 1 (N=323;327)
|
59 Subjects
|
72 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever (Axillary), Dose 1 (N=323;327)
|
105 Subjects
|
141 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever (Axillary), Dose 1 (N=323;327)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever (Axillary), Dose 1 (N=323;327)
|
93 Subjects
|
130 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability, Dose 1 (N=323;327)
|
125 Subjects
|
123 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability, Dose 1 (N=323;327)
|
1 Subjects
|
2 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability, Dose 1 (N=323;327)
|
111 Subjects
|
107 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite, Dose 1 (N=323;327)
|
69 Subjects
|
79 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite, Dose 1 (N=323;327)
|
0 Subjects
|
2 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite, Dose 1 (N=323;327)
|
53 Subjects
|
63 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness, Dose 2 (N=317;313)
|
49 Subjects
|
45 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness, Dose 2 (N=317;313)
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness, Dose 2 (N=317;313)
|
45 Subjects
|
42 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever (Axillary), Dose 2 (N=317;313)
|
82 Subjects
|
106 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever (Axillary), Dose 2 (N=317;313)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever (Axillary), Dose 2 (N=317;313)
|
79 Subjects
|
104 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability, Dose 2 (N=317;313)
|
78 Subjects
|
84 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability, Dose 2 (N=317;313)
|
1 Subjects
|
3 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability, Dose 2 (N=317;313)
|
74 Subjects
|
82 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite, Dose 2 (N=317;313)
|
55 Subjects
|
51 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite, Dose 2 (N=317;313)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite, Dose 2 (N=317;313)
|
48 Subjects
|
47 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness, Dose 3 (N=316;312)
|
29 Subjects
|
25 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness, Dose 3 (N=316;312)
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness, Dose 3 (N=316;312)
|
26 Subjects
|
22 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever (Axillary), Dose 3 (N=316;312)
|
81 Subjects
|
91 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever (Axillary), Dose 3 (N=316;312)
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever (Axillary), Dose 3 (N=316;312)
|
72 Subjects
|
84 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability, Dose 3 (N=316;312)
|
55 Subjects
|
67 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability, Dose 3 (N=316;312)
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability, Dose 3 (N=316;312)
|
51 Subjects
|
60 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite, Dose 3 (N=316;312)
|
45 Subjects
|
41 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite, Dose 3 (N=316;312)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite, Dose 3 (N=316;312)
|
39 Subjects
|
38 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness, Across doses (N=323;327)
|
104 Subjects
|
109 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness, Across doses (N=323;327)
|
0 Subjects
|
5 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness, Across doses (N=323;327)
|
93 Subjects
|
99 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever (Axillary), Across doses (N=323;327)
|
174 Subjects
|
201 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever (Axillary), Across doses (N=323;327)
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever (Axillary), Across doses (N=323;327)
|
164 Subjects
|
193 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability, Across doses (N=323;327)
|
161 Subjects
|
170 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability, Across doses (N=323;327)
|
3 Subjects
|
6 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability, Across doses (N=323;327)
|
150 Subjects
|
154 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite, Across doses (N=323;327)
|
120 Subjects
|
120 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite, Across doses (N=323;327)
|
0 Subjects
|
2 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite, Across doses (N=323;327)
|
103 Subjects
|
105 Subjects
|
SECONDARY outcome
Timeframe: During the 31-day (Day 0-30) follow-up period after each vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
Infanrix/Hib Group
n=330 Participants
Healthy male and female infants who received Infanrix/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
|
Infanrix+Hiberix Group
n=328 Participants
Healthy male and female infants who received Infanrix and Hiberix vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
|
|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
|
171 Subjects
|
189 Subjects
|
SECONDARY outcome
Timeframe: From receipt of first dose of study vaccine (Day 0) to study end (Month 3)Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented.
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/Hib Group
n=330 Participants
Healthy male and female infants who received Infanrix/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
|
Infanrix+Hiberix Group
n=328 Participants
Healthy male and female infants who received Infanrix and Hiberix vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
4 Subjects
|
7 Subjects
|
Adverse Events
Infanrix/Hib Group
Serious events: 4 serious events
Other events: 278 other events
Deaths: 0 deaths
Infanrix+Hiberix Group
Serious events: 7 serious events
Other events: 290 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Infanrix/Hib Group
n=330 participants at risk
Healthy male and female infants who received Infanrix/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
|
Infanrix+Hiberix Group
n=330 participants at risk；n=328 participants at risk
Healthy male and female infants who received Infanrix and Hiberix vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
|
|---|---|---|
|
Infections and infestations
Bronchopneumonia
|
0.30%
1/330 • Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period; Unsolicited AEs: within 31 days (Day 0-30) post-vaccination; SAEs: during the entire study period (from Day 0 to Month 3).
|
0.91%
3/328 • Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period; Unsolicited AEs: within 31 days (Day 0-30) post-vaccination; SAEs: during the entire study period (from Day 0 to Month 3).
|
|
Infections and infestations
Bronchitis
|
0.61%
2/330 • Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period; Unsolicited AEs: within 31 days (Day 0-30) post-vaccination; SAEs: during the entire study period (from Day 0 to Month 3).
|
0.30%
1/328 • Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period; Unsolicited AEs: within 31 days (Day 0-30) post-vaccination; SAEs: during the entire study period (from Day 0 to Month 3).
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/330 • Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period; Unsolicited AEs: within 31 days (Day 0-30) post-vaccination; SAEs: during the entire study period (from Day 0 to Month 3).
|
0.30%
1/328 • Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period; Unsolicited AEs: within 31 days (Day 0-30) post-vaccination; SAEs: during the entire study period (from Day 0 to Month 3).
|
|
Nervous system disorders
Epilepsy
|
0.30%
1/330 • Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period; Unsolicited AEs: within 31 days (Day 0-30) post-vaccination; SAEs: during the entire study period (from Day 0 to Month 3).
|
0.00%
0/328 • Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period; Unsolicited AEs: within 31 days (Day 0-30) post-vaccination; SAEs: during the entire study period (from Day 0 to Month 3).
|
|
Vascular disorders
Hemorrhage
|
0.00%
0/330 • Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period; Unsolicited AEs: within 31 days (Day 0-30) post-vaccination; SAEs: during the entire study period (from Day 0 to Month 3).
|
0.30%
1/328 • Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period; Unsolicited AEs: within 31 days (Day 0-30) post-vaccination; SAEs: during the entire study period (from Day 0 to Month 3).
|
|
Blood and lymphatic system disorders
Idiopathic thrombocytopenic purpura
|
0.00%
0/330 • Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period; Unsolicited AEs: within 31 days (Day 0-30) post-vaccination; SAEs: during the entire study period (from Day 0 to Month 3).
|
0.30%
1/328 • Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period; Unsolicited AEs: within 31 days (Day 0-30) post-vaccination; SAEs: during the entire study period (from Day 0 to Month 3).
|
Other adverse events
| Measure |
Infanrix/Hib Group
n=330 participants at risk
Healthy male and female infants who received Infanrix/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
|
Infanrix+Hiberix Group
n=330 participants at risk；n=328 participants at risk
Healthy male and female infants who received Infanrix and Hiberix vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
|
|---|---|---|
|
General disorders
Pain
|
18.3%
59/323 • Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period; Unsolicited AEs: within 31 days (Day 0-30) post-vaccination; SAEs: during the entire study period (from Day 0 to Month 3).
|
21.5%
71/330 • Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period; Unsolicited AEs: within 31 days (Day 0-30) post-vaccination; SAEs: during the entire study period (from Day 0 to Month 3).
|
|
General disorders
Redness
|
4.3%
14/323 • Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period; Unsolicited AEs: within 31 days (Day 0-30) post-vaccination; SAEs: during the entire study period (from Day 0 to Month 3).
|
7.3%
24/330 • Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period; Unsolicited AEs: within 31 days (Day 0-30) post-vaccination; SAEs: during the entire study period (from Day 0 to Month 3).
|
|
General disorders
Swelling
|
5.3%
17/323 • Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period; Unsolicited AEs: within 31 days (Day 0-30) post-vaccination; SAEs: during the entire study period (from Day 0 to Month 3).
|
3.9%
13/330 • Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period; Unsolicited AEs: within 31 days (Day 0-30) post-vaccination; SAEs: during the entire study period (from Day 0 to Month 3).
|
|
General disorders
Drowsiness
|
32.2%
104/323 • Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period; Unsolicited AEs: within 31 days (Day 0-30) post-vaccination; SAEs: during the entire study period (from Day 0 to Month 3).
|
33.0%
109/330 • Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period; Unsolicited AEs: within 31 days (Day 0-30) post-vaccination; SAEs: during the entire study period (from Day 0 to Month 3).
|
|
General disorders
Fever (Axillary)
|
53.9%
174/323 • Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period; Unsolicited AEs: within 31 days (Day 0-30) post-vaccination; SAEs: during the entire study period (from Day 0 to Month 3).
|
60.9%
201/330 • Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period; Unsolicited AEs: within 31 days (Day 0-30) post-vaccination; SAEs: during the entire study period (from Day 0 to Month 3).
|
|
General disorders
Irritability
|
49.8%
161/323 • Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period; Unsolicited AEs: within 31 days (Day 0-30) post-vaccination; SAEs: during the entire study period (from Day 0 to Month 3).
|
51.5%
170/330 • Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period; Unsolicited AEs: within 31 days (Day 0-30) post-vaccination; SAEs: during the entire study period (from Day 0 to Month 3).
|
|
General disorders
Loss of appetite
|
37.2%
120/323 • Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period; Unsolicited AEs: within 31 days (Day 0-30) post-vaccination; SAEs: during the entire study period (from Day 0 to Month 3).
|
36.4%
120/330 • Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period; Unsolicited AEs: within 31 days (Day 0-30) post-vaccination; SAEs: during the entire study period (from Day 0 to Month 3).
|
|
Infections and infestations
Nasopharyngitis
|
36.1%
119/330 • Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period; Unsolicited AEs: within 31 days (Day 0-30) post-vaccination; SAEs: during the entire study period (from Day 0 to Month 3).
|
38.5%
127/330 • Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period; Unsolicited AEs: within 31 days (Day 0-30) post-vaccination; SAEs: during the entire study period (from Day 0 to Month 3).
|
|
Gastrointestinal disorders
Diarrhea
|
11.5%
38/330 • Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period; Unsolicited AEs: within 31 days (Day 0-30) post-vaccination; SAEs: during the entire study period (from Day 0 to Month 3).
|
11.8%
39/330 • Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period; Unsolicited AEs: within 31 days (Day 0-30) post-vaccination; SAEs: during the entire study period (from Day 0 to Month 3).
|
|
General disorders
Pyrexia
|
5.2%
17/330 • Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period; Unsolicited AEs: within 31 days (Day 0-30) post-vaccination; SAEs: during the entire study period (from Day 0 to Month 3).
|
7.0%
23/330 • Solicited local and general symptoms: during the 4-day (Day 0-3) follow-up period; Unsolicited AEs: within 31 days (Day 0-30) post-vaccination; SAEs: during the entire study period (from Day 0 to Month 3).
|
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