Phase 2
N=624
Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO in Argentinean Infants
Diphtheria · Tetanus · Pertussis · Haemophilus Influenzae Type b · Poliomyelitis
Bottom Line
View on ClinicalTrials.gov: NCT00831311 ↗Enrolled (actual)
624
Serious AEs
6.6%
Results posted
Nov 2013
Primary outcome: 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® — 92; 93; 93; 90 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- DTaP-IPV-HB-PRP~T (Biological); DTaP-IPV//PRP~T combined vaccine & Recombinant hep B vaccine (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Primary completion
- Nov 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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® |
92; 93; 93; 90 | — |
| 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® |
99; 100; 95; 97; 100; 100 | — |
| PRIMARY Geometric Mean Titers of Anti-Tetanus Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® |
1.14; 1.16; 2.29; 1.79 | — |
| 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® |
7.41; 7.04; 4091; 4198; 11.5; 10.5 | — |
| 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™ |
120; 89; 6; 2; 138; 107 | — |
| 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® |
120; 59; 6; 0; 138; 56 | — |
| 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® |
116; 71; 0; 0; 95; 84 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00831311). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.