Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO in Argentinean Infants

Phase 2

Completed

• Conditions: Poliomyelitis; Diphtheria; Tetanus; Pertussis; Haemophilus Influenzae Type b
• Interventions: Biological: DTaP-IPV-HB-PRP~T; Biological: DTaP-IPV//PRP~T combined vaccine & Recombinant hep B vaccine

• Registration Number: NCT00831311
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Primary Completion: 2005-11
• Study Completion: 2007-03
• Study First Submitted: 2009-01-27
• Study First Submitted QC: 2009-01-27
• Study First Posted: 2009-01-28
• Results First Submitted: 2013-09-19
• Results First Submitted QC: 2013-09-19
• Status Verified: 2013-11
• Results First Posted: 2013-11-21
• Last Update Submitted: 2013-11-21
• Last Update Posted: 2013-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 624

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	DTaP-IPV-HB-PRP~T	DTaP IPV HB-PRP\~T vaccine group
2	DTaP-IPV//PRP~T combined vaccine & Recombinant hep B vaccine	PENTAXIM™ and ENGERIX B® vaccines group

Primary Outcome Measures

Name	Time	Method
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).
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.

Secondary Outcome Measures

Name	Time	Method
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
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.