Diphtheria, Tetanus, Pertussis, Hepatitis B, Poliomyelitis, Haemophilus Influenzae Type B Infection
Conditions
Keywords
Diphtheria, Tetanus, Pertussis, Hepatitis B, Poliomyelitis, Invasive Haemophilus influenzae type b., Haemophilus Influenzae Type B Infection
Brief summary
This is a follow-up of Study A3L11 (NCT00404651). Immunogenicity * To describe the antibody persistence following a primary series vaccination of either DTaP-IPV-Hep B-PRP\ T or Infanrix hexa™. * To describe the immunogenicity of a booster dose of DTaP-IPV-HepB-PRP\ T in a subset of subjects. Safety \- To describe the safety profile after a booster dose of DTacP-IPV-HepB-PRP\ T.
Interventions
BIOLOGICALDTaP-IPV-Hep B-PRP~T vaccine (Batch 1)
0.5 mL, Intramuscular
BIOLOGICALDTaP-IPV-Hep B-PRP~T vaccine (Batch 2)
0.5 mL, Intramuscular
BIOLOGICALDTaP-IPV-Hep B-PRP~T vaccine (Batch 3)
0.5 mL, Intramuscular
BIOLOGICALInfanrix Hexa™
0.5 mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Months to 18 Months
Healthy volunteers
Yes
Inclusion criteria
* Toddlers previously included in Study A3L11 (NCT00404651) who completed the three-dose primary series vaccination of either DTaP-IPV-HepB-PRP-T or Infanrix hexa™ at 2, 4 and 6 months of age * Toddlers of 15 to 18 months (456 to 578 days) of age, inclusive * Informed Consent Form signed by at least one parent or legal representative and two mandatory witnesses * Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion criteria
* Participation in another clinical trial in the 4 weeks preceding the booster vaccination. * Planned participation in another clinical trial during the present trial period. * Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroid therapy. * Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to a vaccine containing the same substances. * Chronic illness at a stage that could interfere with trial conduct or completion. * Blood or blood-derived products received in the last 3 months. * Any vaccination in the 4 weeks preceding the booster vaccination. * Any vaccination planned until the next visit. * History of documented pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b or hepatitis B (HB) infection(s) (confirmed either clinically, serologically or microbiologically). * Administration of a vaccine against pertussis, tetanus, diphtheria, polio, Hib, and/or hepatitis B infection(s) since the end of participation in Study A3L11. * Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination. * Known maternal history of human immunodeficiency virus (HIV), Hepatitis B surface antigen (HbsAg) or Hepatitis C seropositivity. * Subjects with any related serious adverse event that occurred following the three-dose primary series administration of the investigational vaccine or of the reference vaccine in Study A3L11. * History of seizures. * Febrile (temperature ≥38.0°C) or acute illness on the day of inclusion * Known contraindication to further vaccination with a pertussis vaccine, i.e.: Encephalopathy; Temperature \>40.0°C within 48 hours following a vaccine injection, not due to another identifiable cause during the primary series; Inconsolable crying that occurred for \>3 hours within 48 hours following vaccine injection during the primary series; Hypotonic hyporesponsive episode within 48 hours following vaccine injection during the primary series; Seizures with or without fever within 3 days following vaccine injection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Day 0 (pre-booster) and Day 30 (one month post-booster) | Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for diphtheria by toxin neutralization test, and for tetanus by enzyme linked immunosorbent assay (ELISA). Antibody titers were measured for poliovirus types 1, 2, and 3 by neutralization assay. Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by ELISA. |
| Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Day 0 (pre-booster) and Day 30 (one month post-booster) | Antibody persistence and immunogenicity response: Level 1: ≥ 10 mIU/mL for hepatitis B (Hep B), ≥ 0.15 µg/mL for Haemophilus influenzae type b (PRP), and ≥ 0.01 IU/mL for diphtheria (D) and tetanus (T). Level 2: ≥ 100 mIU/mL (Hep B), ≥ 1.0 µg/mL (PRP), and ≥ 0.1 IU/mL (D and T) Level 3, ≥ 1.0 IU/mL (D and T). Anti-polio titers were defined as ≥ 8 (1.dil), and pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by a 4 fold increase from Day 0. |
| Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Days 0 up to 7 after any injection | Solicited Injection Site Reactions: Pain, Erythema, Swelling, Extensive Swelling of Vaccinated Limb. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Grade 3 reactions were defined as: Pain, cries when injected limb is moved or movement of injected limb reduced; Erythema and swelling, ≥ 5cm; Extensive swelling of limb; Pyrexia, ≥ 39.6ºC; Vomiting ≥ 6 episodes/24 hours or requiring parenteral hydration; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ feeds or most feeds; Irritability, inconsolable. |
Countries
Mexico
Participant flow
Recruitment details
Participants were enrolled from 25 March 2008 to 28 November 2008 at 5 clinical centers in Mexico.
Pre-assignment details
A total of 881 participants who met the inclusion, but no exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| DTaP-IPV-Hep B-PRP~T Batch 1 Participants had received 3 primary doses of Batch A of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\
T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP\
T) at Day 0 in the present study. | 254 |
| DTaP-IPV-Hep B-PRP~T Batch 2 Participants had received 3 primary doses of Batch B of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\
T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP\
T) at Day 0 in the present study. | 262 |
| DTaP-IPV-Hep B-PRP~T Batch 3 Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\
T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP\
T) at Day 0 in the present study. | 252 |
| Infanrix Hexa™ Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]) (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP\
T at Day 0 in the present study. | 113 |
| Total | 881 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | DTaP-IPV-Hep B-PRP~T Batch 2 | DTaP-IPV-Hep B-PRP~T Batch 3 | DTaP-IPV-Hep B-PRP~T Batch 1 | Infanrix Hexa™ | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 262 Participants | 252 Participants | 254 Participants | 113 Participants | 881 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 17.2 Months STANDARD_DEVIATION 1.47 | 17.4 Months STANDARD_DEVIATION 1.42 | 17.3 Months STANDARD_DEVIATION 1.51 | 17.1 Months STANDARD_DEVIATION 1.51 | 17.3 Months STANDARD_DEVIATION 1.47 |
| Region of Enrollment Mexico | 262 Participants | 252 Participants | 254 Participants | 113 Participants | 881 Participants |
| Sex: Female, Male Female | 125 Participants | 130 Participants | 125 Participants | 58 Participants | 438 Participants |
| Sex: Female, Male Male | 137 Participants | 122 Participants | 129 Participants | 55 Participants | 443 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 188 / 254 | 207 / 262 | 197 / 252 | 92 / 113 |
| serious Total, serious adverse events | 1 / 254 | 1 / 262 | 1 / 252 | 0 / 113 |
Outcome results
Primary
Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T
Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for diphtheria by toxin neutralization test, and for tetanus by enzyme linked immunosorbent assay (ELISA). Antibody titers were measured for poliovirus types 1, 2, and 3 by neutralization assay. Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by ELISA.
Time frame: Day 0 (pre-booster) and Day 30 (one month post-booster)
Population: Geometric mean titers were assessed in a subset of participants with endpoint data who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| DTaP-IPV-Hep B-PRP~T Batch 1 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Polio 1 Post-booster (N = 57, 61, 58, 64) | 7037 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Polio 1 Pre-booster (N = 57, 59, 57, 65) | 614 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Diphtheria Post-booster (N = 58, 61, 58, 65) | 7.78 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti FHA Post-booster (N = 58, 60, 58, 65) | 410 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Tetanus Post-booster (N = 58, 61, 58, 65) | 5.26 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Tetanus Pre-booster (N = 58, 60, 57, 65) | 0.330 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti PT Post-booster (N = 58, 61, 58, 64) | 186 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti PT Pre-booster (N = 57, 59, 55, 64) | 15.6 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti PRP Pre-booster (N = 58, 60, 57, 65) | 1.09 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Hep B Pre-booster (N = 58, 60, 58, 65) | 91.1 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Polio 3 Post-booster (N = 56, 60, 58, 64) | 6597 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Polio 3 Pre-booster (N = 58, 59, 56, 65) | 428 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti PRP Post-booster (N = 58, 61, 58, 65) | 64.0 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti FHA Pre-booster (N = 58, 60, 56, 64) | 42.1 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Polio 2 Post-booster (N = 56, 61, 58, 64) | 10756 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Polio 2 Pre-booster (N = 58, 59, 56, 65) | 936 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Diphtheria Pre-booster (N = 58, 60, 57, 64) | 0.116 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Hep B Post-booster (N = 58, 61, 58, 65) | 2167 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti PRP Pre-booster (N = 58, 60, 57, 65) | 1.32 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Hep B Pre-booster (N = 58, 60, 58, 65) | 127 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Hep B Post-booster (N = 58, 61, 58, 65) | 3998 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti PRP Post-booster (N = 58, 61, 58, 65) | 94.8 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Diphtheria Pre-booster (N = 58, 60, 57, 64) | 0.190 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Diphtheria Post-booster (N = 58, 61, 58, 65) | 15.2 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Tetanus Pre-booster (N = 58, 60, 57, 65) | 0.331 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Tetanus Post-booster (N = 58, 61, 58, 65) | 8.49 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Polio 1 Pre-booster (N = 57, 59, 57, 65) | 663 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Polio 1 Post-booster (N = 57, 61, 58, 64) | 9938 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Polio 2 Pre-booster (N = 58, 59, 56, 65) | 839 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Polio 2 Post-booster (N = 56, 61, 58, 64) | 10224 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Polio 3 Pre-booster (N = 58, 59, 56, 65) | 373 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Polio 3 Post-booster (N = 56, 60, 58, 64) | 9575 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti PT Pre-booster (N = 57, 59, 55, 64) | 14.7 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti PT Post-booster (N = 58, 61, 58, 64) | 200 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti FHA Pre-booster (N = 58, 60, 56, 64) | 33.7 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti FHA Post-booster (N = 58, 60, 58, 65) | 455 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Diphtheria Pre-booster (N = 58, 60, 57, 64) | 0.101 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Polio 1 Post-booster (N = 57, 61, 58, 64) | 8907 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Polio 2 Pre-booster (N = 58, 59, 56, 65) | 531 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti PRP Post-booster (N = 58, 61, 58, 65) | 49.7 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti FHA Post-booster (N = 58, 60, 58, 65) | 346 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Polio 2 Post-booster (N = 56, 61, 58, 64) | 9232 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti FHA Pre-booster (N = 58, 60, 56, 64) | 28.3 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Polio 3 Pre-booster (N = 58, 59, 56, 65) | 241 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti PRP Pre-booster (N = 58, 60, 57, 65) | 0.880 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Polio 3 Post-booster (N = 56, 60, 58, 64) | 5296 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Hep B Pre-booster (N = 58, 60, 58, 65) | 69.2 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti PT Pre-booster (N = 57, 59, 55, 64) | 14.5 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Hep B Post-booster (N = 58, 61, 58, 65) | 1877 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Tetanus Pre-booster (N = 58, 60, 57, 65) | 0.231 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Diphtheria Post-booster (N = 58, 61, 58, 65) | 9.31 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Tetanus Post-booster (N = 58, 61, 58, 65) | 5.55 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti PT Post-booster (N = 58, 61, 58, 64) | 171 Titers |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Polio 1 Pre-booster (N = 57, 59, 57, 65) | 551 Titers |
| Infanrix Hexa™ | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Tetanus Pre-booster (N = 58, 60, 57, 65) | 0.297 Titers |
| Infanrix Hexa™ | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti PT Post-booster (N = 58, 61, 58, 64) | 162 Titers |
| Infanrix Hexa™ | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Polio 3 Post-booster (N = 56, 60, 58, 64) | 13337 Titers |
| Infanrix Hexa™ | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Polio 1 Post-booster (N = 57, 61, 58, 64) | 10173 Titers |
| Infanrix Hexa™ | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti PRP Post-booster (N = 58, 61, 58, 65) | 102 Titers |
| Infanrix Hexa™ | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Hep B Pre-booster (N = 58, 60, 58, 65) | 127 Titers |
| Infanrix Hexa™ | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Hep B Post-booster (N = 58, 61, 58, 65) | 4757 Titers |
| Infanrix Hexa™ | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Polio 2 Pre-booster (N = 58, 59, 56, 65) | 1267 Titers |
| Infanrix Hexa™ | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Diphtheria Pre-booster (N = 58, 60, 57, 64) | 0.081 Titers |
| Infanrix Hexa™ | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti FHA Post-booster (N = 58, 60, 58, 65) | 291 Titers |
| Infanrix Hexa™ | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti PT Pre-booster (N = 57, 59, 55, 64) | 15.3 Titers |
| Infanrix Hexa™ | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Polio 2 Post-booster (N = 56, 61, 58, 64) | 13482 Titers |
| Infanrix Hexa™ | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti PRP Pre-booster (N = 58, 60, 57, 65) | 1.33 Titers |
| Infanrix Hexa™ | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Diphtheria Post-booster (N = 58, 61, 58, 65) | 6.01 Titers |
| Infanrix Hexa™ | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Polio 1 Pre-booster (N = 57, 59, 57, 65) | 887 Titers |
| Infanrix Hexa™ | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Polio 3 Pre-booster (N = 58, 59, 56, 65) | 896 Titers |
| Infanrix Hexa™ | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti Tetanus Post-booster (N = 58, 61, 58, 65) | 6.98 Titers |
| Infanrix Hexa™ | Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Anti FHA Pre-booster (N = 58, 60, 56, 64) | 25.9 Titers |
Primary
Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Antibody persistence and immunogenicity response: Level 1: ≥ 10 mIU/mL for hepatitis B (Hep B), ≥ 0.15 µg/mL for Haemophilus influenzae type b (PRP), and ≥ 0.01 IU/mL for diphtheria (D) and tetanus (T). Level 2: ≥ 100 mIU/mL (Hep B), ≥ 1.0 µg/mL (PRP), and ≥ 0.1 IU/mL (D and T) Level 3, ≥ 1.0 IU/mL (D and T). Anti-polio titers were defined as ≥ 8 (1.dil), and pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by a 4 fold increase from Day 0.
Time frame: Day 0 (pre-booster) and Day 30 (one month post-booster)
Population: Antibody persistence and immunogenicity response were assessed in all participants with endpoint data who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per Protocol Population).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-FHA Post-booster (N=58, 59, 56, 64) | 48 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-D Level 2 Post-booster (N=58, 61, 58, 65) | 56 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-D Level 1 Post-booster (N=58, 61, 58, 65) | 58 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-PRP Level 2 Pre-booster (N=58, 60, 57, 65) | 27 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-Polio 2 Pre-booster (N=58, 59, 56, 65) | 58 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-D Level 2 Pre-booster (N=58, 60, 57, 64) | 31 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-D Level 1 Pre-booster (N=58, 60, 57, 64) | 51 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-PRP Level 1 Post-booster (N=58, 61, 58, 65) | 58 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-Hep B Level 1 Pre-booster (N=58, 60, 58, 65) | 51 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-PRP Level 2 Post booster (N=58, 61, 58, 65) | 58 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-Polio 3 Post-booster (N=56, 60, 58, 64) | 56 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-Polio 1 Post-booster (N=57, 61, 58, 64) | 57 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-Polio 1 Pre-booster (N=57, 59, 57, 65) | 57 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-Hep B Level 2 Pre-booster (N=58, 60, 58, 65) | 29 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-Polio 3 Pre-booster (N=58, 59, 56, 65) | 57 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-T Level 3 Post-booster (N=58, 61, 58, 65) | 52 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-T Level 2 Post-booster (N=58, 61, 58, 65) | 58 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-Hep B Level 1 Post-booster (N=58, 61, 58, 65) | 58 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-Polio 2 Post-booster (N=56, 61, 58, 64) | 56 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-T Level 1 Post-booster (N=58, 61, 58, 65) | 58 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-T Level 2 Pre-booster (N=58, 60, 57, 65) | 48 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-Hep B Level 2 Post-booster (N=58, 61, 58, 65) | 52 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-PT Post-booster (N=57, 59, 55, 63) | 48 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-T Level 1 Pre-booster (N=58, 60, 57, 65) | 58 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-D Level 3 Post-booster (N=58, 61, 58, 65) | 53 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-PRP Level 1 Pre-booster (N=58, 60, 57, 65) | 51 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-Polio 2 Pre-booster (N=58, 59, 56, 65) | 59 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-PT Post-booster (N=57, 59, 55, 63) | 57 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-FHA Post-booster (N=58, 59, 56, 64) | 50 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-Hep B Level 1 Pre-booster (N=58, 60, 58, 65) | 56 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-Hep B Level 2 Pre-booster (N=58, 60, 58, 65) | 39 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-Hep B Level 1 Post-booster (N=58, 61, 58, 65) | 61 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-Hep B Level 2 Post-booster (N=58, 61, 58, 65) | 58 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-PRP Level 1 Pre-booster (N=58, 60, 57, 65) | 54 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-PRP Level 2 Pre-booster (N=58, 60, 57, 65) | 36 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-PRP Level 1 Post-booster (N=58, 61, 58, 65) | 61 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-PRP Level 2 Post booster (N=58, 61, 58, 65) | 61 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-D Level 1 Pre-booster (N=58, 60, 57, 64) | 59 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-D Level 2 Pre-booster (N=58, 60, 57, 64) | 39 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-D Level 1 Post-booster (N=58, 61, 58, 65) | 60 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-D Level 2 Post-booster (N=58, 61, 58, 65) | 60 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-D Level 3 Post-booster (N=58, 61, 58, 65) | 59 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-T Level 1 Pre-booster (N=58, 60, 57, 65) | 60 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-T Level 2 Pre-booster (N=58, 60, 57, 65) | 52 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-T Level 1 Post-booster (N=58, 61, 58, 65) | 61 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-T Level 2 Post-booster (N=58, 61, 58, 65) | 61 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-T Level 3 Post-booster (N=58, 61, 58, 65) | 58 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-Polio 1 Pre-booster (N=57, 59, 57, 65) | 59 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-Polio 1 Post-booster (N=57, 61, 58, 64) | 61 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-Polio 2 Post-booster (N=56, 61, 58, 64) | 61 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-Polio 3 Pre-booster (N=58, 59, 56, 65) | 57 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-Polio 3 Post-booster (N=56, 60, 58, 64) | 60 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-Polio 3 Post-booster (N=56, 60, 58, 64) | 58 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-T Level 3 Post-booster (N=58, 61, 58, 65) | 55 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-Polio 2 Post-booster (N=56, 61, 58, 64) | 58 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-T Level 2 Pre-booster (N=58, 60, 57, 65) | 41 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-Polio 3 Pre-booster (N=58, 59, 56, 65) | 53 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-Polio 1 Pre-booster (N=57, 59, 57, 65) | 57 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-Hep B Level 2 Post-booster (N=58, 61, 58, 65) | 55 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-Hep B Level 1 Pre-booster (N=58, 60, 58, 65) | 51 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-Hep B Level 1 Post-booster (N=58, 61, 58, 65) | 57 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-Polio 1 Post-booster (N=57, 61, 58, 64) | 58 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-PRP Level 1 Pre-booster (N=58, 60, 57, 65) | 47 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-PRP Level 1 Post-booster (N=58, 61, 58, 65) | 58 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-T Level 1 Post-booster (N=58, 61, 58, 65) | 58 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-PRP Level 2 Post booster (N=58, 61, 58, 65) | 55 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-T Level 1 Pre-booster (N=58, 60, 57, 65) | 57 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-D Level 3 Post-booster (N=58, 61, 58, 65) | 53 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-PT Post-booster (N=57, 59, 55, 63) | 52 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-D Level 1 Pre-booster (N=58, 60, 57, 64) | 51 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-T Level 2 Post-booster (N=58, 61, 58, 65) | 58 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-PRP Level 2 Pre-booster (N=58, 60, 57, 65) | 25 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-FHA Post-booster (N=58, 59, 56, 64) | 52 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-D Level 2 Pre-booster (N=58, 60, 57, 64) | 29 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-D Level 2 Post-booster (N=58, 61, 58, 65) | 56 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-Hep B Level 2 Pre-booster (N=58, 60, 58, 65) | 25 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-Polio 2 Pre-booster (N=58, 59, 56, 65) | 56 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-D Level 1 Post-booster (N=58, 61, 58, 65) | 58 Participants |
| Infanrix Hexa™ | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-Polio 1 Pre-booster (N=57, 59, 57, 65) | 65 Participants |
| Infanrix Hexa™ | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-Polio 2 Pre-booster (N=58, 59, 56, 65) | 65 Participants |
| Infanrix Hexa™ | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-D Level 2 Post-booster (N=58, 61, 58, 65) | 63 Participants |
| Infanrix Hexa™ | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-Hep B Level 2 Post-booster (N=58, 61, 58, 65) | 63 Participants |
| Infanrix Hexa™ | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-PT Post-booster (N=57, 59, 55, 63) | 51 Participants |
| Infanrix Hexa™ | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-D Level 3 Post-booster (N=58, 61, 58, 65) | 60 Participants |
| Infanrix Hexa™ | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-Polio 3 Post-booster (N=56, 60, 58, 64) | 64 Participants |
| Infanrix Hexa™ | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-T Level 1 Pre-booster (N=58, 60, 57, 65) | 65 Participants |
| Infanrix Hexa™ | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-Hep B Level 1 Post-booster (N=58, 61, 58, 65) | 65 Participants |
| Infanrix Hexa™ | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-T Level 2 Pre-booster (N=58, 60, 57, 65) | 54 Participants |
| Infanrix Hexa™ | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-Polio 2 Post-booster (N=56, 61, 58, 64) | 64 Participants |
| Infanrix Hexa™ | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-T Level 1 Post-booster (N=58, 61, 58, 65) | 65 Participants |
| Infanrix Hexa™ | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-Hep B Level 2 Pre-booster (N=58, 60, 58, 65) | 38 Participants |
| Infanrix Hexa™ | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-T Level 2 Post-booster (N=58, 61, 58, 65) | 64 Participants |
| Infanrix Hexa™ | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-T Level 3 Post-booster (N=58, 61, 58, 65) | 62 Participants |
| Infanrix Hexa™ | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-Hep B Level 1 Pre-booster (N=58, 60, 58, 65) | 62 Participants |
| Infanrix Hexa™ | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-D Level 1 Post-booster (N=58, 61, 58, 65) | 64 Participants |
| Infanrix Hexa™ | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-Polio 3 Pre-booster (N=58, 59, 56, 65) | 64 Participants |
| Infanrix Hexa™ | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-PRP Level 1 Post-booster (N=58, 61, 58, 65) | 65 Participants |
| Infanrix Hexa™ | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-Polio 1 Post-booster (N=57, 61, 58, 64) | 64 Participants |
| Infanrix Hexa™ | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-PRP Level 2 Post booster (N=58, 61, 58, 65) | 64 Participants |
| Infanrix Hexa™ | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-PRP Level 2 Pre-booster (N=58, 60, 57, 65) | 32 Participants |
| Infanrix Hexa™ | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-FHA Post-booster (N=58, 59, 56, 64) | 57 Participants |
| Infanrix Hexa™ | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-D Level 1 Pre-booster (N=58, 60, 57, 64) | 62 Participants |
| Infanrix Hexa™ | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-D Level 2 Pre-booster (N=58, 60, 57, 64) | 32 Participants |
| Infanrix Hexa™ | Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anti-PRP Level 1 Pre-booster (N=58, 60, 57, 65) | 60 Participants |
Primary
Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Solicited Injection Site Reactions: Pain, Erythema, Swelling, Extensive Swelling of Vaccinated Limb. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Grade 3 reactions were defined as: Pain, cries when injected limb is moved or movement of injected limb reduced; Erythema and swelling, ≥ 5cm; Extensive swelling of limb; Pyrexia, ≥ 39.6ºC; Vomiting ≥ 6 episodes/24 hours or requiring parenteral hydration; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ feeds or most feeds; Irritability, inconsolable.
Time frame: Days 0 up to 7 after any injection
Population: Solicited reactions were assessed in all subjects who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Crying | 91 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Grade 3 injection site Swelling | 2 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Injection site Swelling | 51 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Grade 3 injection site Pain | 8 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Grade 3 Somnolence | 5 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Grade 3 injection site Erythema | 3 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Injection site Erythema | 135 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Grade 3 Anorexia | 6 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Grade 3 Crying | 1 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Grade 3 Vomiting | 0 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Vomiting | 44 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Irritability | 145 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anorexia | 95 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Grade 3 Pyrexia | 2 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Pyrexia | 25 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Grade 3 Irritability | 8 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Somnolence | 55 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Grade 3 Extensive Swelling of Vaccinated Limb | 0 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Extensive Swelling of Vaccinated Limb | 0 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 1 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Injection site Pain | 174 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Grade 3 Somnolence | 2 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anorexia | 101 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Grade 3 Anorexia | 5 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Irritability | 166 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Grade 3 Irritability | 3 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Injection site Pain | 193 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Grade 3 injection site Pain | 11 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Injection site Erythema | 127 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Grade 3 injection site Erythema | 4 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Injection site Swelling | 69 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Grade 3 injection site Swelling | 3 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Extensive Swelling of Vaccinated Limb | 1 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Grade 3 Extensive Swelling of Vaccinated Limb | 1 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Pyrexia | 35 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Grade 3 Pyrexia | 0 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Vomiting | 49 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Grade 3 Vomiting | 1 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Crying | 91 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Grade 3 Crying | 2 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 2 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Somnolence | 66 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Crying | 87 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Grade 3 injection site Swelling | 3 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Extensive Swelling of Vaccinated Limb | 0 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Grade 3 Irritability | 3 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Grade 3 Extensive Swelling of Vaccinated Limb | 0 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Somnolence | 54 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Pyrexia | 28 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Irritability | 166 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Grade 3 Crying | 2 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Grade 3 Pyrexia | 2 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Vomiting | 36 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Grade 3 Anorexia | 3 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Grade 3 Somnolence | 0 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Grade 3 Vomiting | 0 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Injection site Erythema | 135 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Grade 3 injection site Pain | 14 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anorexia | 87 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Grade 3 injection site Erythema | 5 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Injection site Swelling | 58 Participants |
| DTaP-IPV-Hep B-PRP~T Batch 3 | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Injection site Pain | 177 Participants |
| Infanrix Hexa™ | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Grade 3 Crying | 2 Participants |
| Infanrix Hexa™ | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Injection site Erythema | 63 Participants |
| Infanrix Hexa™ | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Grade 3 injection site Swelling | 1 Participants |
| Infanrix Hexa™ | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Grade 3 Irritability | 2 Participants |
| Infanrix Hexa™ | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Crying | 42 Participants |
| Infanrix Hexa™ | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Vomiting | 19 Participants |
| Infanrix Hexa™ | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Extensive Swelling of Vaccinated Limb | 0 Participants |
| Infanrix Hexa™ | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Injection site Pain | 80 Participants |
| Infanrix Hexa™ | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Grade 3 Somnolence | 0 Participants |
| Infanrix Hexa™ | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Somnolence | 33 Participants |
| Infanrix Hexa™ | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Grade 3 Extensive Swelling of Vaccinated Limb | 0 Participants |
| Infanrix Hexa™ | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Irritability | 75 Participants |
| Infanrix Hexa™ | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Injection site Swelling | 35 Participants |
| Infanrix Hexa™ | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Anorexia | 42 Participants |
| Infanrix Hexa™ | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Pyrexia | 22 Participants |
| Infanrix Hexa™ | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Grade 3 injection site Pain | 6 Participants |
| Infanrix Hexa™ | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Grade 3 Vomiting | 1 Participants |
| Infanrix Hexa™ | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Grade 3 injection site Erythema | 1 Participants |
| Infanrix Hexa™ | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Grade 3 Pyrexia | 1 Participants |
| Infanrix Hexa™ | Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine | Grade 3 Anorexia | 3 Participants |