Tetanus, Diphtheria, Acellular Pertussis
Conditions
Brief summary
This study will compare GSK Biologicals' DTPa/Hib vaccine to separately administered DTPa and Hib vaccines in Chinese infants 3, 4 & 5 months of age, in terms of safety and immunogenicity.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
90 Days to 120 Days
Healthy volunteers
Yes
Inclusion criteria
* A male or female between, and including, 90 and 120 days of age at the time of the first vaccination, * written informed consent obtained from the parent or guardian of the subject
Exclusion criteria
* Subjects with known exposure to diphtheria, tetanus, pertussis and/or Haemophilus influenzae disease can not participate, * Subjects who have received previous vaccination against diphtheria, tetanus, acellular pertussis and/or Haemophilus influenzae type b diseases can not participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroprotected Subjects Against Diphteria Toxoid (D) and Tetanus Toxoid (T) | At Month 3 | 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). |
| Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP) | At Month 3 | 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). |
| Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies | At Month 3 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies | At Month 3 | 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). |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses | 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. |
| Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1.0 µg/mL | At Month 3 | The number of subjects with anti-PRP antibody concentrations higher than or equal to (≥) 1.0 µg/mL post primary vaccination is reported. |
| Number of Subjects With Unsolicited Adverse Events (AEs) | During the 31-day (Day 0-30) follow-up period after each vaccination | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. |
| Number of Subjects With Serious Adverse Events (SAEs) | From receipt of first dose of study vaccine (Day 0) to study end (Month 3) | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses | 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. |
| Concentrations for Anti-D and Anti-T Antibodies | At Month 0 and Month 3 | Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International units per milliliter (IU/mL). |
| Concentrations for Anti-PRP Antibodies | At Month 0 and Month 3 | Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram/milliliter (µg/mL). |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 330 |
| 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. | 330 |
| Total | 660 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawn due to adverse events | 1 | 5 |
| Overall Study | Withdrawn for other reasons | 13 | 11 |
Baseline characteristics
| Characteristic | Infanrix/Hib Group | Infanrix+Hiberix Group | Total |
|---|---|---|---|
| Age, Continuous | 14.2 Weeks STANDARD_DEVIATION 1.12 | 14.2 Weeks STANDARD_DEVIATION 1.18 | 14.2 Weeks STANDARD_DEVIATION 1.15 |
| Sex: Female, Male Female | 149 Participants | 167 Participants | 316 Participants |
| Sex: Female, Male Male | 181 Participants | 163 Participants | 344 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 278 / 330 | 290 / 330 |
| serious Total, serious adverse events | 4 / 330 | 7 / 328 |
Outcome results
Primary
Number of Seroprotected Subjects Against Diphteria Toxoid (D) and Tetanus Toxoid (T)
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).
Time frame: At Month 3
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infanrix/Hib Group | Number of Seroprotected Subjects Against Diphteria Toxoid (D) and Tetanus Toxoid (T) | Anti-D | 162 Subjects |
| Infanrix/Hib Group | Number of Seroprotected Subjects Against Diphteria Toxoid (D) and Tetanus Toxoid (T) | Anti-T | 163 Subjects |
| Infanrix+Hiberix Group | Number of Seroprotected Subjects Against Diphteria Toxoid (D) and Tetanus Toxoid (T) | Anti-D | 164 Subjects |
| Infanrix+Hiberix Group | Number of Seroprotected Subjects Against Diphteria Toxoid (D) and Tetanus Toxoid (T) | Anti-T | 164 Subjects |
Comparison: Difference in seroprotection rates against diphteria toxoid:~To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose primary vaccination course.95% CI: [-1.68, 3.39]
Comparison: Difference in seroprotection rates against tetanus toxoid:~To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose vaccination course.95% CI: [-2.29, 2.3]
Primary
Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP)
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).
Time frame: At Month 3
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Infanrix/Hib Group | Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP) | 158 Subjects |
| Infanrix+Hiberix Group | Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP) | 164 Subjects |
Comparison: Difference in seroprotection rates against PRP:~To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose vaccination course.95% CI: [0.15, 6.18]
Primary
Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies
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.
Time frame: At Month 3
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infanrix/Hib Group | Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies | Anti-PT | 163 Subjects |
| Infanrix/Hib Group | Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies | Anti-FHA | 163 Subjects |
| Infanrix/Hib Group | Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies | Anti-PRN | 159 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies | Anti-PT | 164 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies | Anti-FHA | 164 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies | Anti-PRN | 162 Subjects |
Comparison: Difference in vaccine response rates against PT:~To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose vaccination course.95% CI: [-2.29, 2.3]
Comparison: Difference in vaccine response rates against FHA:~To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose vaccination course.95% CI: [-2.29, 2.3]
Comparison: Difference in vaccine response rates against PRN:~To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose vaccination course.95% CI: [-2.17, 5.07]
Secondary
Concentrations for Anti-D and Anti-T Antibodies
Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International units per milliliter (IU/mL).
Time frame: At Month 0 and Month 3
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix/Hib Group | Concentrations for Anti-D and Anti-T Antibodies | Anti-D (Month 0) | 0.050 IU/mL |
| Infanrix/Hib Group | Concentrations for Anti-D and Anti-T Antibodies | Anti-D (Month 3) | 0.545 IU/mL |
| Infanrix/Hib Group | Concentrations for Anti-D and Anti-T Antibodies | Anti-T (Month 0) | 0.050 IU/mL |
| Infanrix/Hib Group | Concentrations for Anti-D and Anti-T Antibodies | Anti-T (Month 3) | 2.990 IU/mL |
| Infanrix+Hiberix Group | Concentrations for Anti-D and Anti-T Antibodies | Anti-T (Month 3) | 3.214 IU/mL |
| Infanrix+Hiberix Group | Concentrations for Anti-D and Anti-T Antibodies | Anti-D (Month 0) | 0.051 IU/mL |
| Infanrix+Hiberix Group | Concentrations for Anti-D and Anti-T Antibodies | Anti-T (Month 0) | 0.050 IU/mL |
| Infanrix+Hiberix Group | Concentrations for Anti-D and Anti-T Antibodies | Anti-D (Month 3) | 0.567 IU/mL |
Secondary
Concentrations for Anti-PRP Antibodies
Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram/milliliter (µg/mL).
Time frame: At Month 0 and Month 3
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix/Hib Group | Concentrations for Anti-PRP Antibodies | Anti-PRP, Month 0 (N=163;164) | 0.083 µg/mL |
| Infanrix/Hib Group | Concentrations for Anti-PRP Antibodies | Anti-PRP, Month 3 (N=162;164) | 3.559 µg/mL |
| Infanrix+Hiberix Group | Concentrations for Anti-PRP Antibodies | Anti-PRP, Month 0 (N=163;164) | 0.083 µg/mL |
| Infanrix+Hiberix Group | Concentrations for Anti-PRP Antibodies | Anti-PRP, Month 3 (N=162;164) | 6.120 µg/mL |
Secondary
Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies
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).
Time frame: At Month 3
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix/Hib Group | Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PT | 66.0 EL.U/mL |
| Infanrix/Hib Group | Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-FHA | 207.2 EL.U/mL |
| Infanrix/Hib Group | Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PRN | 172.4 EL.U/mL |
| Infanrix+Hiberix Group | Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PT | 67.0 EL.U/mL |
| Infanrix+Hiberix Group | Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-FHA | 198.1 EL.U/mL |
| Infanrix+Hiberix Group | Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PRN | 177.5 EL.U/mL |
Secondary
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1.0 µg/mL
The number of subjects with anti-PRP antibody concentrations higher than or equal to (≥) 1.0 µg/mL post primary vaccination is reported.
Time frame: At Month 3
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Infanrix/Hib Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1.0 µg/mL | 145 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1.0 µg/mL | 156 Subjects |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
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.
Time frame: During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infanrix/Hib Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 (N=317;313) | 23 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 (N=323;326) | 2 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 (N=323;326) | 5 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 (N=323;326) | 0 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 (N=323;326) | 3 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 (N=323;326) | 1 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 (N=323;326) | 44 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 (N=317;313) | 0 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 (N=317;313) | 3 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 (N=317;313) | 2 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 (N=317;313) | 9 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 (N=317;313) | 1 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 3 (N=316;312) | 19 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 3 (N=316;312) | 1 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 3 (N=316;312) | 7 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 3 (N=316;312) | 1 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 3 (N=316;312) | 8 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 3 (N=316;312) | 2 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses (N=323;326) | 59 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses (N=323;326) | 3 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses (N=323;326) | 14 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses (N=323;326) | 2 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses (N=323;326) | 17 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses (N=323;326) | 4 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses (N=323;326) | 13 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 (N=323;326) | 46 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 3 (N=316;312) | 25 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 (N=323;326) | 3 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses (N=323;326) | 71 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 (N=323;326) | 11 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 3 (N=316;312) | 0 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 (N=323;326) | 0 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses (N=323;326) | 0 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 (N=323;326) | 1 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 3 (N=316;312) | 8 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 (N=323;326) | 0 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses (N=323;326) | 3 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 (N=317;313) | 32 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 3 (N=316;312) | 0 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 (N=317;313) | 0 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses (N=323;326) | 0 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 (N=317;313) | 11 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 3 (N=316;312) | 6 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 (N=317;313) | 0 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses (N=323;326) | 24 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 (N=317;313) | 7 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 3 (N=316;312) | 0 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 (N=317;313) | 0 Subjects |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
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.
Time frame: During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever (Axillary), Dose 1 (N=323;327) | 93 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 3 (N=316;312) | 29 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 2 (N=317;313) | 49 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 3 (N=316;312) | 0 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 1 (N=323;327) | 0 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 3 (N=316;312) | 26 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 2 (N=317;313) | 0 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever (Axillary), Dose 3 (N=316;312) | 81 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 1 (N=323;327) | 125 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever (Axillary), Dose 3 (N=316;312) | 1 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 2 (N=317;313) | 45 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever (Axillary), Dose 3 (N=316;312) | 72 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 1 (N=323;327) | 1 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 3 (N=316;312) | 55 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever (Axillary), Dose 2 (N=317;313) | 82 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 3 (N=316;312) | 1 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever (Axillary), Dose 1 (N=323;327) | 105 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 3 (N=316;312) | 51 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever (Axillary), Dose 2 (N=317;313) | 0 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 3 (N=316;312) | 45 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 1 (N=323;327) | 111 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 3 (N=316;312) | 0 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever (Axillary), Dose 2 (N=317;313) | 79 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 3 (N=316;312) | 39 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 1 (N=323;327) | 71 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Across doses (N=323;327) | 104 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 2 (N=317;313) | 78 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Across doses (N=323;327) | 0 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 1 (N=323;327) | 69 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Across doses (N=323;327) | 93 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 2 (N=317;313) | 1 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever (Axillary), Across doses (N=323;327) | 174 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever (Axillary), Dose 1 (N=323;327) | 0 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever (Axillary), Across doses (N=323;327) | 1 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 2 (N=317;313) | 74 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever (Axillary), Across doses (N=323;327) | 164 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Across doses (N=323;327) | 161 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 1 (N=323;327) | 0 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Across doses (N=323;327) | 3 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 2 (N=317;313) | 55 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Across doses (N=323;327) | 150 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 1 (N=323;327) | 59 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Across doses (N=323;327) | 120 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 2 (N=317;313) | 0 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Across doses (N=323;327) | 0 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 1 (N=323;327) | 53 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Across doses (N=323;327) | 103 Subjects |
| Infanrix/Hib Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 2 (N=317;313) | 48 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever (Axillary), Dose 3 (N=316;312) | 84 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 1 (N=323;327) | 84 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 1 (N=323;327) | 3 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 1 (N=323;327) | 72 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever (Axillary), Dose 1 (N=323;327) | 141 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever (Axillary), Dose 1 (N=323;327) | 0 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever (Axillary), Dose 1 (N=323;327) | 130 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 1 (N=323;327) | 123 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 1 (N=323;327) | 2 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 1 (N=323;327) | 107 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 1 (N=323;327) | 79 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 1 (N=323;327) | 2 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 1 (N=323;327) | 63 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 2 (N=317;313) | 45 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 2 (N=317;313) | 1 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 2 (N=317;313) | 42 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever (Axillary), Dose 2 (N=317;313) | 106 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever (Axillary), Dose 2 (N=317;313) | 0 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever (Axillary), Dose 2 (N=317;313) | 104 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 2 (N=317;313) | 84 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 2 (N=317;313) | 3 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 2 (N=317;313) | 82 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 2 (N=317;313) | 51 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 2 (N=317;313) | 0 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 2 (N=317;313) | 47 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 3 (N=316;312) | 25 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 3 (N=316;312) | 1 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 3 (N=316;312) | 22 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever (Axillary), Dose 3 (N=316;312) | 91 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever (Axillary), Dose 3 (N=316;312) | 0 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever (Axillary), Across doses (N=323;327) | 193 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 3 (N=316;312) | 67 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 3 (N=316;312) | 1 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 3 (N=316;312) | 60 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 3 (N=316;312) | 41 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 3 (N=316;312) | 0 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 3 (N=316;312) | 38 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Across doses (N=323;327) | 109 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Across doses (N=323;327) | 5 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Across doses (N=323;327) | 99 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever (Axillary), Across doses (N=323;327) | 201 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever (Axillary), Across doses (N=323;327) | 0 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Across doses (N=323;327) | 170 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Across doses (N=323;327) | 6 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Across doses (N=323;327) | 154 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Across doses (N=323;327) | 120 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Across doses (N=323;327) | 2 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Across doses (N=323;327) | 105 Subjects |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Infanrix/Hib Group | Number of Subjects With Serious Adverse Events (SAEs) | 4 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Serious Adverse Events (SAEs) | 7 Subjects |
Secondary
Number of Subjects With Unsolicited Adverse Events (AEs)
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.
Time frame: During the 31-day (Day 0-30) follow-up period after each vaccination
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine administration documented.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Infanrix/Hib Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 171 Subjects |
| Infanrix+Hiberix Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 189 Subjects |