Diphtheria, Hepatitis B, Pertussis, Poliomyelitis, Tetanus
Conditions
Keywords
Diphtheria, Tetanus, Pertussis, whooping cough, Haemophilus influenzae type b, Hepatitis B, Poliomyelitis
Brief summary
This study will assess both the antibody persistence of the investigational vaccine and the immune response and safety of a booster dose of PENTAXIM™ vaccine in 18 months-old toddlers who participated in an earlier study in order to determine if they are still protected before they receive a booster dose of D, T, IPV, pertussis or Hib vaccines and also to assess the quality of the induced immune memory in response to a booster dose of the same vaccine as in the primary series. Primary Objective: To describe the antibody persistence at 18 months of age and the booster effect of a dose of PENTAXIM™ on immunogenicity. Secondary objective: To describe the safety profile of the booster dose PENTAXIM™ in each vaccine group defined by the vaccines received during the primary series.
Interventions
BIOLOGICALDTaP-IPV//PRP~T combined vaccine
0.5 mL, Intramuscular
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
510 Days to 578 Days
Healthy volunteers
Yes
Inclusion criteria
* Toddler at 18 months of age (range: 510 days to 578 days of age inclusive) * Participated in study A3L02 (NCT00831311) and has completed the three-dose primary series with either diphtheria, tetanus, pertussis (2-component acellular), recombinant Hepatitis B Hansenula and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\ T) or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 months of age * Written informed consent form signed by at least one parent or by a legal representative and an independent witness * Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion criteria
* Participation in another clinical trial in the four weeks preceding the trial vaccination * Planned participation in another clinical trial during the present trial period * Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months or long-term systemic corticosteroids 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 six months * Any vaccination in the four weeks preceding the trial * Vaccination with a vaccine containing diphtheria, tetanus, pertussis, Haemophilus influenzae type b, polio, or hepatitis B antigen, since the end of the primary series * History of documented diphtheria, tetanus, pertussis, Haemophilus influenzae type b, polio, or hepatitis B infection(s) (confirmed either clinically, serologically, or microbiologically) * Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination * History of seizures * Fever (axillary temperature ≥37.4°C or equivalent rectal temperature ≥38.0°C) or acute illness on the day of inclusion * Known contraindication to further vaccination with a pertussis vaccine such as: * Encephalopathy; Inconsolable crying for \>3 hours within 48 hours following vaccine injection * Hypotonic hyporesponsive episode within 48 hours following vaccine injection * Seizures with or without fever within three days following vaccine injection * Axillary temperature \>39.4°C or equivalent rectal temperature \> 40.0°C within 48 hours following vaccine injection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Day 0 (Before booster vaccination) | Antibody persistence (pre-booster) were defined as titers ≥ 10 mIU/mL for hepatitis B (Hep B;); ≥ 0.15 µg/mL for Haemophilus influenzae type b (PRP); ≥ 0.01 IU/mL for Diphtheria and Tetanus; ≥ 8 (1/dil) for polio types 1, 2, and 3; and ≥ 4 EU/mL for Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA). |
| Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Day 30 Post-booster Vaccination | Booster response were defined as titers ≥ 1.0 µg/mL for Haemophilus influenzae type b (PRP); ≥ 0.1 IU/mL for Diphtheria and Tetanus; ≥ 8 (1/dil) for Polio types 1, 2, and 3; and for Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) ≥ 4 EU/mL and a ≥ 4 fold increase from pre-booster to post-booster value. |
| Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Day 0 (pre-booster) and Day 30 post-booster | Antibody titers determination: Hepatitis B (Hep B) by enhanced chemiluminescence assay; Haemophilus influenzae type b (PRP), Tetanus, Pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA); Diphtheria by neutralization test; Poliovirus types 1,2, and 3 by microneutralization assay. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™ | Day 0 up to Day 30 post-booster vaccination | Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Grade 3 was defined as: Pain, cries when injected limb is moved or movement of limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia, ≥ 39.6ºC; Vomiting, ≥ 6 episodes/24 hour or requiring parenteral hydration; Crying, \> 3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refuses ≥ 3 feeds/meals or refuses most feeds/meals; and Irritability, inconsolable. |
Countries
Argentina
Participant flow
Recruitment details
Participants were enrolled from 15 February 2006 to 03 October 2006 at 1 clinical center in Argentina.
Pre-assignment details
A total of 458 participants who met all the inclusion and none of the exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| DTacP-IPV-Hep B-PRP~T Group Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses 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-HepB-PRP\
T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311). | 232 |
| PENTAXIM™ and ENGERIX B® Group Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311). | 226 |
| Total | 458 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Total | DTacP-IPV-Hep B-PRP~T Group | PENTAXIM™ and ENGERIX B® Group |
|---|---|---|---|
| Age, Categorical <=18 years | 458 Participants | 232 Participants | 226 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 17.6 Months STANDARD_DEVIATION 0.465 | 17.6 Months STANDARD_DEVIATION 0.436 | 17.7 Months STANDARD_DEVIATION 0.492 |
| Region of Enrollment Argentina | 458 Participants | 232 Participants | 226 Participants |
| Sex: Female, Male Female | 214 Participants | 107 Participants | 107 Participants |
| Sex: Female, Male Male | 244 Participants | 125 Participants | 119 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 134 / 231 | 137 / 223 |
| serious Total, serious adverse events | 3 / 231 | 1 / 223 |
Outcome results
Primary
Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Antibody titers determination: Hepatitis B (Hep B) by enhanced chemiluminescence assay; Haemophilus influenzae type b (PRP), Tetanus, Pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA); Diphtheria by neutralization test; Poliovirus types 1,2, and 3 by microneutralization assay.
Time frame: Day 0 (pre-booster) and Day 30 post-booster
Population: Geometric mean titers were assessed in all participants with endpoint data who received the booster vaccine (Intent-to-Treat Analysis Set for immunogenicity).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| DTacP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Diphtheria Pre-booster (N = 228, 221) | 0.022 Titers |
| DTacP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Polio 1 Post-booster (N = 211, 209) | 7243 Titers |
| DTacP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-PRP Pre-booster (N = 224, 217) | 0.399 Titers |
| DTacP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Polio 2 Pre-booster (N = 217, 204) | 370 Titers |
| DTacP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Diphtheria Post-booster (N = 225, 221) | 1.92 Titers |
| DTacP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Polio 2 Post-booster (N = 208, 210) | 8512 Titers |
| DTacP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Hepatitis B Pre-booster (N = 228, 222) | 87.6 Titers |
| DTacP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Polio 3 Pre-booster (N = 214, 203) | 257 Titers |
| DTacP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Tetanus Pre-booster (N = 229, 216) | 0.287 Titers |
| DTacP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Polio 3 Post-booster (N = 205, 205) | 10975 Titers |
| DTacP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-PRP Post-booster (N = 223, 216) | 27.4 Titers |
| DTacP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-PT Pre-booster (N = 216, 212) | 10.7 Titers |
| DTacP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Tetanus Post-booster (N = 222, 219) | 4.81 Titers |
| DTacP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-PT Post-booster (N = 226, 220) | 226 Titers |
| DTacP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-FHA Pre-booster (N = 230, 220) | 28.2 Titers |
| DTacP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-FHA Post-booster (N = 227, 221) | 335 Titers |
| DTacP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Polio 1 Pre-booster (N= 214, 205) | 303 Titers |
| PENTAXIM™ and ENGERIX B® Group | Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-FHA Post-booster (N = 227, 221) | 333 Titers |
| PENTAXIM™ and ENGERIX B® Group | Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Hepatitis B Pre-booster (N = 228, 222) | 197 Titers |
| PENTAXIM™ and ENGERIX B® Group | Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-PRP Pre-booster (N = 224, 217) | 0.326 Titers |
| PENTAXIM™ and ENGERIX B® Group | Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-PRP Post-booster (N = 223, 216) | 41.4 Titers |
| PENTAXIM™ and ENGERIX B® Group | Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Diphtheria Pre-booster (N = 228, 221) | 0.018 Titers |
| PENTAXIM™ and ENGERIX B® Group | Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Diphtheria Post-booster (N = 225, 221) | 2.11 Titers |
| PENTAXIM™ and ENGERIX B® Group | Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Tetanus Pre-booster (N = 229, 216) | 0.171 Titers |
| PENTAXIM™ and ENGERIX B® Group | Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Tetanus Post-booster (N = 222, 219) | 4.54 Titers |
| PENTAXIM™ and ENGERIX B® Group | Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Polio 1 Pre-booster (N= 214, 205) | 232 Titers |
| PENTAXIM™ and ENGERIX B® Group | Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Polio 1 Post-booster (N = 211, 209) | 9996 Titers |
| PENTAXIM™ and ENGERIX B® Group | Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Polio 2 Pre-booster (N = 217, 204) | 292 Titers |
| PENTAXIM™ and ENGERIX B® Group | Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Polio 2 Post-booster (N = 208, 210) | 11229 Titers |
| PENTAXIM™ and ENGERIX B® Group | Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Polio 3 Pre-booster (N = 214, 203) | 223 Titers |
| PENTAXIM™ and ENGERIX B® Group | Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Polio 3 Post-booster (N = 205, 205) | 14482 Titers |
| PENTAXIM™ and ENGERIX B® Group | Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-PT Pre-booster (N = 216, 212) | 12.9 Titers |
| PENTAXIM™ and ENGERIX B® Group | Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-FHA Pre-booster (N = 230, 220) | 19.0 Titers |
| PENTAXIM™ and ENGERIX B® Group | Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-PT Post-booster (N = 226, 220) | 325 Titers |
Primary
Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Antibody persistence (pre-booster) were defined as titers ≥ 10 mIU/mL for hepatitis B (Hep B;); ≥ 0.15 µg/mL for Haemophilus influenzae type b (PRP); ≥ 0.01 IU/mL for Diphtheria and Tetanus; ≥ 8 (1/dil) for polio types 1, 2, and 3; and ≥ 4 EU/mL for Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA).
Time frame: Day 0 (Before booster vaccination)
Population: Antibody Persistence was assessed in all enrolled participants with pre-booster vaccination data (Intent-to-Treat population).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTacP-IPV-Hep B-PRP~T Group | Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-PRP (N = 224, 217) | 171 Participants |
| DTacP-IPV-Hep B-PRP~T Group | Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Polio 2 (N = 217, 204) | 215 Participants |
| DTacP-IPV-Hep B-PRP~T Group | Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Tetanus (N = 229, 216) | 229 Participants |
| DTacP-IPV-Hep B-PRP~T Group | Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Polio 3 (N = 214, 203) | 205 Participants |
| DTacP-IPV-Hep B-PRP~T Group | Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Diphtheria (N = 228, 221) | 169 Participants |
| DTacP-IPV-Hep B-PRP~T Group | Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Pertussis Toxoid (N= 216, 212) | 190 Participants |
| DTacP-IPV-Hep B-PRP~T Group | Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Polio 1 (N = 214, 205) | 213 Participants |
| DTacP-IPV-Hep B-PRP~T Group | Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Filamentous Hemagglutinin (N = 230, 220) | 228 Participants |
| DTacP-IPV-Hep B-PRP~T Group | Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Hepatitis B (N = 228, 222) | 195 Participants |
| PENTAXIM™ and ENGERIX B® Group | Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Filamentous Hemagglutinin (N = 230, 220) | 213 Participants |
| PENTAXIM™ and ENGERIX B® Group | Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Hepatitis B (N = 228, 222) | 221 Participants |
| PENTAXIM™ and ENGERIX B® Group | Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-PRP (N = 224, 217) | 164 Participants |
| PENTAXIM™ and ENGERIX B® Group | Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Diphtheria (N = 228, 221) | 165 Participants |
| PENTAXIM™ and ENGERIX B® Group | Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Tetanus (N = 229, 216) | 216 Participants |
| PENTAXIM™ and ENGERIX B® Group | Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Polio 1 (N = 214, 205) | 205 Participants |
| PENTAXIM™ and ENGERIX B® Group | Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Polio 2 (N = 217, 204) | 203 Participants |
| PENTAXIM™ and ENGERIX B® Group | Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Polio 3 (N = 214, 203) | 199 Participants |
| PENTAXIM™ and ENGERIX B® Group | Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Pertussis Toxoid (N= 216, 212) | 190 Participants |
Primary
Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Booster response were defined as titers ≥ 1.0 µg/mL for Haemophilus influenzae type b (PRP); ≥ 0.1 IU/mL for Diphtheria and Tetanus; ≥ 8 (1/dil) for Polio types 1, 2, and 3; and for Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) ≥ 4 EU/mL and a ≥ 4 fold increase from pre-booster to post-booster value.
Time frame: Day 30 Post-booster Vaccination
Population: Booster responses were assessed in all vaccinated participants with endpoint data following the booster vaccination (Intent-to-Treat population).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTacP-IPV-Hep B-PRP~T Group | Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Diphtheria (N = 225, 221) | 216 Participants |
| DTacP-IPV-Hep B-PRP~T Group | Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Polio 2 (N = 208, 210) | 208 Participants |
| DTacP-IPV-Hep B-PRP~T Group | Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-PRP (N = 223, 216) | 220 Participants |
| DTacP-IPV-Hep B-PRP~T Group | Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Polio 3 (N = 205, 205) | 205 Participants |
| DTacP-IPV-Hep B-PRP~T Group | Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Pertussis Toxoid (4-Fold Rise: N = 211, 208) | 202 Participants |
| DTacP-IPV-Hep B-PRP~T Group | Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Tetanus (N = 222, 219) | 222 Participants |
| DTacP-IPV-Hep B-PRP~T Group | Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Filamentous Hemagglutinin (N = 227, 221) | 227 Participants |
| DTacP-IPV-Hep B-PRP~T Group | Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Pertussis Toxoid (N = 226, 220) | 226 Participants |
| DTacP-IPV-Hep B-PRP~T Group | Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-FHA (4-Fold Rise: N = 225, 215) | 198 Participants |
| DTacP-IPV-Hep B-PRP~T Group | Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Polio 1 (N = 211, 209) | 211 Participants |
| PENTAXIM™ and ENGERIX B® Group | Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-FHA (4-Fold Rise: N = 225, 215) | 202 Participants |
| PENTAXIM™ and ENGERIX B® Group | Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Pertussis Toxoid (N = 226, 220) | 220 Participants |
| PENTAXIM™ and ENGERIX B® Group | Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-PRP (N = 223, 216) | 215 Participants |
| PENTAXIM™ and ENGERIX B® Group | Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Diphtheria (N = 225, 221) | 214 Participants |
| PENTAXIM™ and ENGERIX B® Group | Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Tetanus (N = 222, 219) | 219 Participants |
| PENTAXIM™ and ENGERIX B® Group | Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Polio 1 (N = 211, 209) | 209 Participants |
| PENTAXIM™ and ENGERIX B® Group | Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Polio 2 (N = 208, 210) | 210 Participants |
| PENTAXIM™ and ENGERIX B® Group | Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Pertussis Toxoid (4-Fold Rise: N = 211, 208) | 199 Participants |
| PENTAXIM™ and ENGERIX B® Group | Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Filamentous Hemagglutinin (N = 227, 221) | 221 Participants |
| PENTAXIM™ and ENGERIX B® Group | Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Anti-Polio 3 (N = 205, 205) | 205 Participants |
Secondary
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™
Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Grade 3 was defined as: Pain, cries when injected limb is moved or movement of limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia, ≥ 39.6ºC; Vomiting, ≥ 6 episodes/24 hour or requiring parenteral hydration; Crying, \> 3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refuses ≥ 3 feeds/meals or refuses most feeds/meals; and Irritability, inconsolable.
Time frame: Day 0 up to Day 30 post-booster vaccination
Population: Solicited injection site and systemic reactions were assessed in the enrolled and vaccinated participants, Safety Analysis Set population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTacP-IPV-Hep B-PRP~T Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™ | Injection site Pain | 112 Participants |
| DTacP-IPV-Hep B-PRP~T Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™ | Grade 3 Injection site Pain | 8 Participants |
| DTacP-IPV-Hep B-PRP~T Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™ | Injection site Erythema | 66 Participants |
| DTacP-IPV-Hep B-PRP~T Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™ | Grade 3 Injection site Erythema | 7 Participants |
| DTacP-IPV-Hep B-PRP~T Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™ | Injection site Swelling | 63 Participants |
| DTacP-IPV-Hep B-PRP~T Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™ | Grade 3 Injection site Swelling | 5 Participants |
| DTacP-IPV-Hep B-PRP~T Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™ | Any Pyrexia | 47 Participants |
| DTacP-IPV-Hep B-PRP~T Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™ | Grade 3 Pyrexia | 9 Participants |
| DTacP-IPV-Hep B-PRP~T Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™ | Any Vomiting | 18 Participants |
| DTacP-IPV-Hep B-PRP~T Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™ | Grade 3 Vomiting | 0 Participants |
| DTacP-IPV-Hep B-PRP~T Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™ | Any Crying | 61 Participants |
| DTacP-IPV-Hep B-PRP~T Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™ | Grade 3 Crying | 3 Participants |
| DTacP-IPV-Hep B-PRP~T Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™ | Any Somnolence | 52 Participants |
| DTacP-IPV-Hep B-PRP~T Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™ | Grade 3 Somnolence | 6 Participants |
| DTacP-IPV-Hep B-PRP~T Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™ | Any Anorexia | 59 Participants |
| DTacP-IPV-Hep B-PRP~T Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™ | Grade 3 Anorexia | 9 Participants |
| DTacP-IPV-Hep B-PRP~T Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™ | Any Irritability | 85 Participants |
| DTacP-IPV-Hep B-PRP~T Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™ | Grade 3 Irritability | 6 Participants |
| PENTAXIM™ and ENGERIX B® Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™ | Grade 3 Somnolence | 2 Participants |
| PENTAXIM™ and ENGERIX B® Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™ | Injection site Pain | 117 Participants |
| PENTAXIM™ and ENGERIX B® Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™ | Grade 3 Vomiting | 0 Participants |
| PENTAXIM™ and ENGERIX B® Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™ | Grade 3 Injection site Pain | 12 Participants |
| PENTAXIM™ and ENGERIX B® Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™ | Grade 3 Irritability | 1 Participants |
| PENTAXIM™ and ENGERIX B® Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™ | Injection site Erythema | 93 Participants |
| PENTAXIM™ and ENGERIX B® Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™ | Any Crying | 53 Participants |
| PENTAXIM™ and ENGERIX B® Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™ | Grade 3 Injection site Erythema | 19 Participants |
| PENTAXIM™ and ENGERIX B® Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™ | Any Anorexia | 52 Participants |
| PENTAXIM™ and ENGERIX B® Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™ | Injection site Swelling | 89 Participants |
| PENTAXIM™ and ENGERIX B® Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™ | Grade 3 Crying | 2 Participants |
| PENTAXIM™ and ENGERIX B® Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™ | Grade 3 Injection site Swelling | 20 Participants |
| PENTAXIM™ and ENGERIX B® Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™ | Any Irritability | 78 Participants |
| PENTAXIM™ and ENGERIX B® Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™ | Any Pyrexia | 44 Participants |
| PENTAXIM™ and ENGERIX B® Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™ | Any Somnolence | 44 Participants |
| PENTAXIM™ and ENGERIX B® Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™ | Grade 3 Pyrexia | 4 Participants |
| PENTAXIM™ and ENGERIX B® Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™ | Grade 3 Anorexia | 3 Participants |
| PENTAXIM™ and ENGERIX B® Group | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™ | Any Vomiting | 18 Participants |