Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b, Poliomyelitis
Conditions
Keywords
Diphtheria, Tetanus, Pertussis, Whooping cough, Hepatitis B, Poliomyelitis, Haemophilus influenzae type b
Brief summary
Primary Objective: * To demonstrate that the immune response of the DTaP-IPV-Hep B-PRP\ T is non-inferior for all valences to those of the association of PENTAXIM™ and ENGERIX B® PEDIATRICO one month after a three-dose primary series. Secondary Objectives: * To describe in each group the immunogenicity parameters one month after the three-dose primary series. * To describe safety profile after each vaccination in both groups.
Interventions
BIOLOGICALDTaP-IPV-HB-PRP~T
0.5 mL, Intramuscular
BIOLOGICALDTaP-IPV//PRP~T combined vaccine & Recombinant hep B vaccine
0.5 mL, Intramuscular (right and left thighs, respectively)
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Days to 70 Days
Healthy volunteers
Yes
Inclusion criteria
: * Infant of either gender, aged 50 to 70 days inclusive * Mother is negative for HBsAg * Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg * Written informed consent form signed by at least one parent or by another legal representative and an independent witness * Parent/legal representative able to attend scheduled visits and to comply with the trial procedures during the entire duration of the trial.
Exclusion criteria
: * Axillary temperature ≥37.1°C on the day of inclusion * Current or planned enrolment in another clinical trial during the clinical trial period * Known mother's history of Human Immunodeficiency Virus (HIV) infection * Known immunodeficiency (congenital or acquired) or induced by immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy since birth, or systemic corticosteroids in the last 4 weeks (≥0.5 mg per kilogram and per day equivalent prednisolone and lasting more than 7 days) * Receipt of blood-derived products since birth * Acute symptoms or severe chronic illness (e.g. cardiac, renal insufficiency, diabetes, auto immune disorders, congenital defect) that may interfere with conduct or completion of trial * Occurrence of seizures since birth * Hypersensitivity to any of the vaccine components * Coagulopathy contraindicating intramuscular injection * History of (documented) clinical or serological/microbiological confirmed infection due to pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b (Hib) or hepatitis B (HB) diseases * History of vaccination against pertussis, tetanus, diphtheria, polio, Hib or HB infections * Vaccination within the last 4 weeks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Seroconversion for Anti-pertussis Toxoid and Anti-filamentous Hemagglutinin Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | 1 month post last vaccination | Seroconversion was assessed by means of enzyme immunoassay (EIA) for anti-pertussis toxoid (PT) and anti-filamentous hemagglutinin (FHA) antibodies. Seroconversion was defined as ≥ 4 fold increase in antibody titers from Day 0 to 30 days after the third vaccination. |
| Percentage of Participants With Seroprotection for Anti-Hepatitis B, Anti-Polyribosyl Ribitol Phosphate (PRP), Anti-Tetanus, Anti-Diphtheria, and Anti-Polio Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Day 150 (1 month post-vaccination 3) | Immunogenicity was assessed by radioimmunoassay (RIA) for anti-hepatitis B (HBs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-tetanus, serum neutralization (SN) for anti-diphtheria, and microneutralization for anti-polio type 1, 2, and 3 antibodies. Seroprotection was defined as titers ≥ 10 mIU/mL for anti-Hepatitis Bs, ≥ 0.15 μg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-tetanus and anti-diphtheria, and ≥ 8 1/dil for anti-polio types 1, 2, and 3 at 30 days after the third vaccination. |
| Geometric Mean Titers of Anti-Tetanus Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Day 150 (1 month post-vaccination 3) | Geometric mean titers to Tetanus antigen was assessed by means of enzyme immunoassay (EIA) before the first vaccination (at Day 0) and 1 month after the third vaccination (Day 150). |
| Geometric Mean Titers of Anti-Polio Types 1, 2, and 3 Antibodies Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Day 150 (1 month post-vaccination 3) | Geometric mean titers to the Polio Antigens were assessed by means of microneutralization assay for anti-polio types 1, 2, and 3 before the first vaccination (at Day 0) and 1 month post-vaccination 3 (Day 150). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Day 0 up to Day 7 post-vaccination | Solicited injection site reactions - erythema, edema, induration, and pain were assessed in each participant at the DTaP-IPV-Hep B-PRP\ T and ENGERIX B® injection sites. |
| Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Day 0 up to Day 7 post-vaccination | Solicited systemic reactions: Pyrexia (temperature), Somnolence, Irritability, Anorexia, Vomiting not otherwise specified (NOS), Diarrhea NOS, and Crying were assessed in each participant following vaccination. Grade 3 reactions defined as: Pyrexia (temperature), ≥ 39.1°C; Somnolence, sleeping most of the time; Irritability, continuously irritable for ≥ 3 hours; Anorexia, refused most or all feeds; Vomiting NOS, frequent vomiting and inability to have any oral intake; Diarrhea NOS, multiple liquid stools without any solid material; and Crying, persistent, inconsolable cry ≥ 3 hours and/or high-pitched cry. |
| Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Day 0 up to Day 7 post-vaccination | Solicited injection site reactions - erythema, edema, induration, and pain were assessed in each participant at the DTaP-IPV-Hep B-PRP\ T and PENTAXIM™ injection sites |
Countries
Argentina
Participant flow
Recruitment details
Participants were enrolled and treated from 26 October 2004 to 10 November 2005 in 1 clinical center in Argentina.
Pre-assignment details
A total of 624 participants who met the inclusion but no exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: DTaP-IPV-Hep B-PRP~T Participants received 3 doses of the DTaP-IPV-Hep B-PRP\
T vaccine, 1 dose each at 2, 4, and 6 months of age. | 312 |
| Group 2: PENTAXIM™ and ENGERIX B® Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age. | 312 |
| Total | 624 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Definitive Contraindication | 3 | 3 |
| Overall Study | Lost to Follow-up | 3 | 0 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 6 | 4 |
Baseline characteristics
| Characteristic | Group 2: PENTAXIM™ and ENGERIX B® | Group 1: DTaP-IPV-Hep B-PRP~T | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 312 Participants | 312 Participants | 624 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 | 1.77 Months STANDARD_DEVIATION 0.11 | 1.76 Months STANDARD_DEVIATION 0.12 | 1.76 Months STANDARD_DEVIATION 0.11 |
| Region of Enrollment Argentina | 312 Participants | 312 Participants | 624 Participants |
| Sex: Female, Male Female | 147 Participants | 148 Participants | 295 Participants |
| Sex: Female, Male Male | 165 Participants | 164 Participants | 329 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 305 / 311 | 307 / 312 |
| serious Total, serious adverse events | 19 / 311 | 22 / 312 |
Outcome results
Primary
Geometric Mean Titers of Anti-Polio Types 1, 2, and 3 Antibodies Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Geometric mean titers to the Polio Antigens were assessed by means of microneutralization assay for anti-polio types 1, 2, and 3 before the first vaccination (at Day 0) and 1 month post-vaccination 3 (Day 150).
Time frame: Day 150 (1 month post-vaccination 3)
Population: Geometric mean titers to the Polio Antigens were assessed in the per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: DTaP-IPV-Hep B-PRP~T | Geometric Mean Titers of Anti-Polio Types 1, 2, and 3 Antibodies Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Anti-Polio Type 1 Day 0 (N = 250, 258) | 7.41 Titers |
| Group 1: DTaP-IPV-Hep B-PRP~T | Geometric Mean Titers of Anti-Polio Types 1, 2, and 3 Antibodies Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Anti-Polio Type 1 Day 150 (N = 259, 268) | 4091 Titers |
| Group 1: DTaP-IPV-Hep B-PRP~T | Geometric Mean Titers of Anti-Polio Types 1, 2, and 3 Antibodies Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Anti-Polio Type 2 Day 0 (N = 249, 261) | 11.5 Titers |
| Group 1: DTaP-IPV-Hep B-PRP~T | Geometric Mean Titers of Anti-Polio Types 1, 2, and 3 Antibodies Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Anti-Polio Type 2 Day 150 (N = 257, 269) | 3244 Titers |
| Group 1: DTaP-IPV-Hep B-PRP~T | Geometric Mean Titers of Anti-Polio Types 1, 2, and 3 Antibodies Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Anti-Polio Type 3 Day 0 (N = 246, 254) | 6.89 Titers |
| Group 1: DTaP-IPV-Hep B-PRP~T | Geometric Mean Titers of Anti-Polio Types 1, 2, and 3 Antibodies Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Anti-Polio Type 3 Day 150 (N = 257, 263) | 3839 Titers |
| Group 2: PENTAXIM™ and ENGERIX B® | Geometric Mean Titers of Anti-Polio Types 1, 2, and 3 Antibodies Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Anti-Polio Type 3 Day 0 (N = 246, 254) | 6.77 Titers |
| Group 2: PENTAXIM™ and ENGERIX B® | Geometric Mean Titers of Anti-Polio Types 1, 2, and 3 Antibodies Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Anti-Polio Type 1 Day 0 (N = 250, 258) | 7.04 Titers |
| Group 2: PENTAXIM™ and ENGERIX B® | Geometric Mean Titers of Anti-Polio Types 1, 2, and 3 Antibodies Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Anti-Polio Type 2 Day 150 (N = 257, 269) | 3223 Titers |
| Group 2: PENTAXIM™ and ENGERIX B® | Geometric Mean Titers of Anti-Polio Types 1, 2, and 3 Antibodies Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Anti-Polio Type 1 Day 150 (N = 259, 268) | 4198 Titers |
| Group 2: PENTAXIM™ and ENGERIX B® | Geometric Mean Titers of Anti-Polio Types 1, 2, and 3 Antibodies Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Anti-Polio Type 3 Day 150 (N = 257, 263) | 5502 Titers |
| Group 2: PENTAXIM™ and ENGERIX B® | Geometric Mean Titers of Anti-Polio Types 1, 2, and 3 Antibodies Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Anti-Polio Type 2 Day 0 (N = 249, 261) | 10.5 Titers |
Primary
Geometric Mean Titers of Anti-Tetanus Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Geometric mean titers to Tetanus antigen was assessed by means of enzyme immunoassay (EIA) before the first vaccination (at Day 0) and 1 month after the third vaccination (Day 150).
Time frame: Day 150 (1 month post-vaccination 3)
Population: Geometric mean titers to the vaccine antigens were assessed in the per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: DTaP-IPV-Hep B-PRP~T | Geometric Mean Titers of Anti-Tetanus Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Day 0 (N = 256, 267) | 1.14 Titers |
| Group 1: DTaP-IPV-Hep B-PRP~T | Geometric Mean Titers of Anti-Tetanus Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Day 150 (N = 260, 271) | 2.29 Titers |
| Group 2: PENTAXIM™ and ENGERIX B® | Geometric Mean Titers of Anti-Tetanus Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Day 0 (N = 256, 267) | 1.16 Titers |
| Group 2: PENTAXIM™ and ENGERIX B® | Geometric Mean Titers of Anti-Tetanus Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Day 150 (N = 260, 271) | 1.79 Titers |
Primary
Percentage of Participants With Seroconversion for Anti-pertussis Toxoid and Anti-filamentous Hemagglutinin Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Seroconversion was assessed by means of enzyme immunoassay (EIA) for anti-pertussis toxoid (PT) and anti-filamentous hemagglutinin (FHA) antibodies. Seroconversion was defined as ≥ 4 fold increase in antibody titers from Day 0 to 30 days after the third vaccination.
Time frame: 1 month post last vaccination
Population: Seroconversion for anti-pertussis toxoid and anti-filamentous hemagglutinin antibodies was assessed in the per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: DTaP-IPV-Hep B-PRP~T | Percentage of Participants With Seroconversion for Anti-pertussis Toxoid and Anti-filamentous Hemagglutinin Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Anti-Pertussis toxoid (N = 233, 241) | 92 Percentage of Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Percentage of Participants With Seroconversion for Anti-pertussis Toxoid and Anti-filamentous Hemagglutinin Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Anti-Filamentous hemagglutinin (N = 250, 249) | 93 Percentage of Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Percentage of Participants With Seroconversion for Anti-pertussis Toxoid and Anti-filamentous Hemagglutinin Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Anti-Pertussis toxoid (N = 233, 241) | 93 Percentage of Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Percentage of Participants With Seroconversion for Anti-pertussis Toxoid and Anti-filamentous Hemagglutinin Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Anti-Filamentous hemagglutinin (N = 250, 249) | 90 Percentage of Participants |
Primary
Percentage of Participants With Seroprotection for Anti-Hepatitis B, Anti-Polyribosyl Ribitol Phosphate (PRP), Anti-Tetanus, Anti-Diphtheria, and Anti-Polio Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Immunogenicity was assessed by radioimmunoassay (RIA) for anti-hepatitis B (HBs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-tetanus, serum neutralization (SN) for anti-diphtheria, and microneutralization for anti-polio type 1, 2, and 3 antibodies. Seroprotection was defined as titers ≥ 10 mIU/mL for anti-Hepatitis Bs, ≥ 0.15 μg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-tetanus and anti-diphtheria, and ≥ 8 1/dil for anti-polio types 1, 2, and 3 at 30 days after the third vaccination.
Time frame: Day 150 (1 month post-vaccination 3)
Population: Seroprotection to the vaccine antigens was assessed in the per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: DTaP-IPV-Hep B-PRP~T | Percentage of Participants With Seroprotection for Anti-Hepatitis B, Anti-Polyribosyl Ribitol Phosphate (PRP), Anti-Tetanus, Anti-Diphtheria, and Anti-Polio Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Anti-Tetanus (N = 260, 271) | 100 Percentage of Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Percentage of Participants With Seroprotection for Anti-Hepatitis B, Anti-Polyribosyl Ribitol Phosphate (PRP), Anti-Tetanus, Anti-Diphtheria, and Anti-Polio Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Anti-Polio Type 1 (N = 259, 268) | 100 Percentage of Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Percentage of Participants With Seroprotection for Anti-Hepatitis B, Anti-Polyribosyl Ribitol Phosphate (PRP), Anti-Tetanus, Anti-Diphtheria, and Anti-Polio Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Anti-PRP (N = 260, 270) | 95 Percentage of Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Percentage of Participants With Seroprotection for Anti-Hepatitis B, Anti-Polyribosyl Ribitol Phosphate (PRP), Anti-Tetanus, Anti-Diphtheria, and Anti-Polio Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Anti-Polio Type 2 (N = 257, 269) | 100 Percentage of Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Percentage of Participants With Seroprotection for Anti-Hepatitis B, Anti-Polyribosyl Ribitol Phosphate (PRP), Anti-Tetanus, Anti-Diphtheria, and Anti-Polio Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Anti-Diphtheria (N = 260, 271) | 100 Percentage of Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Percentage of Participants With Seroprotection for Anti-Hepatitis B, Anti-Polyribosyl Ribitol Phosphate (PRP), Anti-Tetanus, Anti-Diphtheria, and Anti-Polio Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Anti-Polio Type 3 (N = 257, 263) | 100 Percentage of Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Percentage of Participants With Seroprotection for Anti-Hepatitis B, Anti-Polyribosyl Ribitol Phosphate (PRP), Anti-Tetanus, Anti-Diphtheria, and Anti-Polio Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Anti-Hepatitis B (N = 258, 271) | 99 Percentage of Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Percentage of Participants With Seroprotection for Anti-Hepatitis B, Anti-Polyribosyl Ribitol Phosphate (PRP), Anti-Tetanus, Anti-Diphtheria, and Anti-Polio Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Anti-Polio Type 3 (N = 257, 263) | 100 Percentage of Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Percentage of Participants With Seroprotection for Anti-Hepatitis B, Anti-Polyribosyl Ribitol Phosphate (PRP), Anti-Tetanus, Anti-Diphtheria, and Anti-Polio Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Anti-Hepatitis B (N = 258, 271) | 100 Percentage of Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Percentage of Participants With Seroprotection for Anti-Hepatitis B, Anti-Polyribosyl Ribitol Phosphate (PRP), Anti-Tetanus, Anti-Diphtheria, and Anti-Polio Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Anti-PRP (N = 260, 270) | 97 Percentage of Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Percentage of Participants With Seroprotection for Anti-Hepatitis B, Anti-Polyribosyl Ribitol Phosphate (PRP), Anti-Tetanus, Anti-Diphtheria, and Anti-Polio Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Anti-Tetanus (N = 260, 271) | 100 Percentage of Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Percentage of Participants With Seroprotection for Anti-Hepatitis B, Anti-Polyribosyl Ribitol Phosphate (PRP), Anti-Tetanus, Anti-Diphtheria, and Anti-Polio Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Anti-Diphtheria (N = 260, 271) | 100 Percentage of Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Percentage of Participants With Seroprotection for Anti-Hepatitis B, Anti-Polyribosyl Ribitol Phosphate (PRP), Anti-Tetanus, Anti-Diphtheria, and Anti-Polio Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Anti-Polio Type 1 (N = 259, 268) | 100 Percentage of Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Percentage of Participants With Seroprotection for Anti-Hepatitis B, Anti-Polyribosyl Ribitol Phosphate (PRP), Anti-Tetanus, Anti-Diphtheria, and Anti-Polio Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Anti-Polio Type 2 (N = 257, 269) | 100 Percentage of Participants |
Secondary
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B®
Solicited injection site reactions - erythema, edema, induration, and pain were assessed in each participant at the DTaP-IPV-Hep B-PRP\ T and ENGERIX B® injection sites.
Time frame: Day 0 up to Day 7 post-vaccination
Population: Safety was assessed on the safety analysis (intend-to-treat) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Any Injection site Induration Post-vaccination 3 | 125 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Any Injection site Pain Post-vaccination 3 | 126 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Grade 3 Pain (Cries when moved) Post-vaccination 3 | 15 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Any Injection site Erythema Post-vaccination 1 | 120 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Grade 3 Erythema (≥5 cm) Post-vaccination 1 | 6 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Any Injection site Erythema Post-vaccination 2 | 138 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Grade 3 Erythema (≥5 cm) Post-vaccination 2 | 6 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Any Injection site Erythema Post-vaccination 3 | 143 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Grade 3 Erythema (≥5 cm) Post-vaccination 3 | 7 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Any Injection site Edema Post-vaccination 1 | 97 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Grade 3 Edema (≥ 5 cm) Post-vaccination 1 | 10 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Any Injection site Edema Post-vaccination 2 | 88 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Grade 3 Edema (≥5 cm) Post-vaccination 2 | 4 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Any Injection site Edema Post-vaccination 3 | 100 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Any Injection site Induration Post-vaccination 1 | 140 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Grade 3 Induration (≥ 5 cm) Post-vaccination 1 | 6 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Any Injection site Induration Post-vaccination 2 | 123 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Grade 3 Induration (≥ 5 cm) Post-vaccination 2 | 3 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Grade 3 Edema (≥ 5 cm) Post-vaccination 3 | 3 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Grade 3 Induration (≥5 cm) Post-vaccination 3 | 2 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Any Injection site Pain Post-vaccination 1 | 195 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Grade 3 Pain (Cries when moved) Post-vaccination 1 | 83 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Any Injection site Pain Post-vaccination 2 | 139 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Grade 3 Pain (Cries when moved) Post-vaccination 2 | 36 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Grade 3 Pain (Cries when moved) Post-vaccination 2 | 11 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Any Injection site Edema Post-vaccination 3 | 42 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Any Injection site Pain Post-vaccination 3 | 84 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Grade 3 Edema (≥ 5 cm) Post-vaccination 3 | 0 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Grade 3 Induration (≥5 cm) Post-vaccination 3 | 0 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Any Injection site Erythema Post-vaccination 1 | 59 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Any Injection site Induration Post-vaccination 1 | 45 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Grade 3 Erythema (≥5 cm) Post-vaccination 1 | 0 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Any Injection site Pain Post-vaccination 2 | 88 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Any Injection site Erythema Post-vaccination 2 | 56 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Grade 3 Induration (≥ 5 cm) Post-vaccination 1 | 0 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Grade 3 Erythema (≥5 cm) Post-vaccination 2 | 1 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Any Injection site Pain Post-vaccination 1 | 123 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Any Injection site Erythema Post-vaccination 3 | 67 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Any Injection site Induration Post-vaccination 2 | 41 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Grade 3 Erythema (≥5 cm) Post-vaccination 3 | 0 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Grade 3 Pain (Cries when moved) Post-vaccination 3 | 6 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Any Injection site Edema Post-vaccination 1 | 43 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Grade 3 Induration (≥ 5 cm) Post-vaccination 2 | 0 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Grade 3 Edema (≥ 5 cm) Post-vaccination 1 | 0 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Grade 3 Pain (Cries when moved) Post-vaccination 1 | 26 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Any Injection site Edema Post-vaccination 2 | 37 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Any Injection site Induration Post-vaccination 3 | 51 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B® | Grade 3 Edema (≥5 cm) Post-vaccination 2 | 0 Participants |
Secondary
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™
Solicited injection site reactions - erythema, edema, induration, and pain were assessed in each participant at the DTaP-IPV-Hep B-PRP\ T and PENTAXIM™ injection sites
Time frame: Day 0 up to Day 7 post-vaccination
Population: Safety was assessed on the safety analysis (intent-to- treat) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Grade 3 Erythema (≥ 5 cm) Post-vaccination 2 | 6 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Any Injection site Erythema Post-vaccination 3 | 143 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Any Injection site Edema Post-vaccination 3 | 100 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Grade 3 Edema (≥ 5 cm) Post-vaccination 3 | 3 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Any Injection site Erythema Post-vaccination 1 | 120 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Grade 3 Erythema (≥ 5 cm) Post-vaccination 1 | 6 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Any Injection site Erythema Post-vaccination 2 | 138 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Grade 3 Erythema (≥ 5 cm) Post-vaccination 3 | 7 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Any Injection site Edema Post-vaccination 1 | 97 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Grade 3 Edema (≥ 5 cm) Post-vaccination 1 | 10 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Any Injection site Edema Post-vaccination 2 | 88 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Grade 3 Edema (≥ 5 cm) Post-vaccination 2 | 4 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Any Injection site Induration Post-vaccination 1 | 140 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Grade 3 Induration (≥ 5 cm) Post-vaccination 1 | 6 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Any Injection site Induration Post-vaccination 2 | 123 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Grade 3 Induration (≥ 5 cm) Post-vaccination 2 | 3 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Any Injection site Induration Post-vaccination 3 | 125 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Grade 3 Induration (≥ 5 cm) Post-vaccination 3 | 2 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Any Injection site Pain Post-vaccination 1 | 195 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Grade 3 Pain (Cries when moved) Post-vaccination 1 | 83 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Any Injection site Pain Post-vaccination 2 | 139 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Grade 3 Pain (Cries when moved) Post-vaccination 2 | 36 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Any Injection site Pain Post-vaccination 3 | 126 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Grade 3 Pain (Cries when moved) Post-vaccination 3 | 15 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Any Injection site Pain Post-vaccination 3 | 105 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Grade 3 Erythema (≥ 5 cm) Post-vaccination 2 | 0 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Any Injection site Induration Post-vaccination 1 | 100 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Any Injection site Pain Post-vaccination 1 | 138 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Any Injection site Edema Post-vaccination 3 | 73 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Grade 3 Induration (≥ 5 cm) Post-vaccination 1 | 0 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Grade 3 Pain (Cries when moved) Post-vaccination 2 | 13 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Any Injection site Erythema Post-vaccination 1 | 89 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Any Injection site Induration Post-vaccination 2 | 99 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Grade 3 Erythema (≥ 5 cm) Post-vaccination 1 | 2 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Grade 3 Pain (Cries when moved) Post-vaccination 1 | 34 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Any Injection site Erythema Post-vaccination 2 | 107 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Any Injection site Erythema Post-vaccination 3 | 115 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Grade 3 Induration (≥ 5 cm) Post-vaccination 2 | 1 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Grade 3 Erythema (≥ 5 cm) Post-vaccination 3 | 4 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Grade 3 Pain (Cries when moved) Post-vaccination 3 | 8 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Any Injection site Edema Post-vaccination 1 | 62 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Any Injection site Induration Post-vaccination 3 | 106 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Grade 3 Edema (≥ 5 cm) Post-vaccination 1 | 0 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Any Injection site Pain Post-vaccination 2 | 115 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Any Injection site Edema Post-vaccination 2 | 72 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Grade 3 Induration (≥ 5 cm) Post-vaccination 3 | 4 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Grade 3 Edema (≥ 5 cm) Post-vaccination 2 | 1 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ | Grade 3 Edema (≥ 5 cm) Post-vaccination 3 | 3 Participants |
Secondary
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Solicited systemic reactions: Pyrexia (temperature), Somnolence, Irritability, Anorexia, Vomiting not otherwise specified (NOS), Diarrhea NOS, and Crying were assessed in each participant following vaccination. Grade 3 reactions defined as: Pyrexia (temperature), ≥ 39.1°C; Somnolence, sleeping most of the time; Irritability, continuously irritable for ≥ 3 hours; Anorexia, refused most or all feeds; Vomiting NOS, frequent vomiting and inability to have any oral intake; Diarrhea NOS, multiple liquid stools without any solid material; and Crying, persistent, inconsolable cry ≥ 3 hours and/or high-pitched cry.
Time frame: Day 0 up to Day 7 post-vaccination
Population: Safety was assessed on the safety analysis (intent-to- treat) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Any Irritability Post-vaccination 3 (N = 300, 304) | 115 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Grade 3 Pyrexia Post-vaccination 2 (N = 302, 307) | 1 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Grade 3 Irritability Post-vaccination 3; N=300,304 | 11 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Any Pyrexia Post-vaccination 2 (N = 302, 307) | 95 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Any Anorexia Post-vaccination 1 (N = 311, 312) | 78 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Grade 3 Diarrhea NOS Post-vaccination 2: N=302,307 | 2 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Grade 3 Anorexia Post-vaccination 1 (N = 311, 312) | 4 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Any Pyrexia Post-vaccination 3 (N = 300, 304) | 99 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Any Anorexia Post-vaccination 2 (N = 302, 307) | 68 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Grade 3 Anorexia Post-vaccination 2 (N = 302, 307) | 5 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Crying Post-vaccination 1 (N = 311, 312) | 152 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Any Anorexia Post-vaccination 3 (N = 300, 304) | 80 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Grade 3 Pyrexia Post-vaccination 3 (N = 300, 304) | 3 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Any Vomiting NOS Post-vaccination 1 (N = 311, 312) | 56 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Any Somnolence Post-vaccination 2 (N = 302, 307) | 87 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Grade 3 Vomiting NOS Post-vaccination 1: N=311,312 | 2 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Any Vomiting NOS Post-vaccination 2 (N = 302, 307) | 34 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Grade 3 Somnolence Post-vaccination 1 (N=311, 312) | 63 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Grade 3 Vomiting NOS Post-vaccination 2: N=302,307 | 2 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Grade 3 Somnolence Post-vaccination 2 (N=302, 307) | 18 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Any Vomiting NOS Post-vaccination 3 (N = 300, 304) | 42 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Grade 3 Crying Post-vaccination 2 (N = 302, 307) | 1 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Grade 3 Vomiting NOS Post-vaccination 3: N=300,304 | 2 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Any Somnolence Post-vaccination 3 (N = 300, 304) | 85 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Any Diarrhea NOS Post-vaccination 1 (N = 311, 312) | 68 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Grade 3 Crying Post-vaccination 3 (N = 300, 304) | 2 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Grade 3 Diarrhea NOS Post-vaccination 1: N=311,312 | 10 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Grade 3 Somnolence Post-vaccination 3 (N=300, 304) | 22 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Any Diarrhea NOS Post-vaccination 2 (N = 302, 307) | 51 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Grade 3 Anorexia Post-vaccination 3 (N = 300, 304) | 12 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Any Irritability Post-vaccination 1 (N = 311, 312) | 161 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Any Diarrhea NOS Post-vaccination 3 (N = 300, 304) | 33 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Any Pyrexia Post-vaccination 1 (N = 311, 312) | 116 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Grade 3 Diarrhea NOS Post-vaccination 3: N=300,304 | 3 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Grade 3 Irritability Post-vaccination 1; N=311,312 | 0 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Grade 3 Crying Post-vaccination 1 (N = 311, 312) | 9 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Any Somnolence Post-vaccination 1 (N = 311, 312) | 143 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Any Crying Post-vaccination 2 (N = 302, 307) | 104 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Any Irritability Post-vaccination 2 (N = 302, 307) | 129 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Grade 3 Pyrexia Post-vaccination 1 (N = 311, 312) | 0 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Any Crying Post-vaccination 3 (N = 300, 304) | 78 Participants |
| Group 1: DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Grade 3 Irritability Post-vaccination 2; N=302,307 | 13 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Any Crying Post-vaccination 3 (N = 300, 304) | 71 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Grade 3 Pyrexia Post-vaccination 3 (N = 300, 304) | 2 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Any Somnolence Post-vaccination 1 (N = 311, 312) | 109 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Grade 3 Somnolence Post-vaccination 1 (N=311, 312) | 48 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Grade 3 Irritability Post-vaccination 2; N=302,307 | 7 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Any Anorexia Post-vaccination 2 (N = 302, 307) | 52 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Grade 3 Anorexia Post-vaccination 3 (N = 300, 304) | 2 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Grade 3 Vomiting NOS Post-vaccination 1: N=311,312 | 3 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Crying Post-vaccination 1 (N = 311, 312) | 113 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Grade 3 Crying Post-vaccination 3 (N = 300, 304) | 1 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Any Pyrexia Post-vaccination 1 (N = 311, 312) | 71 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Grade 3 Pyrexia Post-vaccination 1 (N = 311, 312) | 0 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Grade 3 Pyrexia Post-vaccination 2 (N = 302, 307) | 1 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Any Pyrexia Post-vaccination 3 (N = 300, 304) | 83 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Any Somnolence Post-vaccination 2 (N = 302, 307) | 73 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Grade 3 Somnolence Post-vaccination 2 (N=302, 307) | 13 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Any Somnolence Post-vaccination 3 (N = 300, 304) | 65 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Grade 3 Somnolence Post-vaccination 3 (N=300, 304) | 14 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Any Irritability Post-vaccination 1 (N = 311, 312) | 134 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Grade 3 Irritability Post-vaccination 1; N=311,312 | 0 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Any Irritability Post-vaccination 2 (N = 302, 307) | 112 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Any Irritability Post-vaccination 3 (N = 300, 304) | 97 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Grade 3 Irritability Post-vaccination 3; N=300,304 | 6 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Any Anorexia Post-vaccination 1 (N = 311, 312) | 72 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Grade 3 Anorexia Post-vaccination 1 (N = 311, 312) | 2 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Grade 3 Anorexia Post-vaccination 2 (N = 302, 307) | 4 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Any Anorexia Post-vaccination 3 (N = 300, 304) | 53 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Any Vomiting NOS Post-vaccination 1 (N = 311, 312) | 61 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Any Vomiting NOS Post-vaccination 2 (N = 302, 307) | 41 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Grade 3 Vomiting NOS Post-vaccination 2: N=302,307 | 1 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Any Vomiting NOS Post-vaccination 3 (N = 300, 304) | 23 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Grade 3 Vomiting NOS Post-vaccination 3: N=300,304 | 0 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Any Diarrhea NOS Post-vaccination 1 (N = 311, 312) | 60 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Grade 3 Diarrhea NOS Post-vaccination 1: N=311,312 | 6 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Any Diarrhea NOS Post-vaccination 2 (N = 302, 307) | 43 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Grade 3 Diarrhea NOS Post-vaccination 2: N=302,307 | 2 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Any Diarrhea NOS Post-vaccination 3 (N = 300, 304) | 31 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Grade 3 Diarrhea NOS Post-vaccination 3: N=300,304 | 2 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Grade 3 Crying Post-vaccination 1 (N = 311, 312) | 1 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Any Crying Post-vaccination 2 (N = 302, 307) | 89 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Grade 3 Crying Post-vaccination 2 (N = 302, 307) | 2 Participants |
| Group 2: PENTAXIM™ and ENGERIX B® | Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® | Any Pyrexia Post-vaccination 2 (N = 302, 307) | 84 Participants |