Comparison of a DTaP-IPV-HB-PRP~T Combined Vaccine to Infanrix™-Hexa, When Administered With Prevnar® in Thai Infants

Phase 3

Completed

• Conditions: Hepatitis B; Polio; Diphtheria; Pertussis; Haemophilus Influenzae Type b
• Interventions: Biological: DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines; Biological: DTaP-HB-IPV and Pneumococcal polysaccharide vaccines

• Registration Number: NCT00401531
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

The purpose of the study is to provide immunogenicity and safety data of the investigational hexavalent vaccine when it is given concomitantly (the same day at separate injection sites) with Prevnar, according to the 2-4-6 month immunization schedule, following one dose of HB vaccine at birth.

Primary Objective:

To demonstrate that the hexavalent DTaP-IPV-HB-PRP\~T combined vaccine induces an immune response that is at least as good as the response following Infanrix™-Hexa in terms of seroprotection rates to HB and PRP, one month after a 3 dose primary series (2, 4, and 6 months), when co-administered with Prevnar®

Secondary Objectives:

Immunogenicity:

To describe in each group the immunogenicity parameters to each vaccine component (for DTaP-IPV-HB-PRP\~T and Infanrix™-Hexa) one month after the third dose of the primary series.

Safety:

To describe the overall safety after each injection.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-11-16
• Study First Submitted QC: 2006-11-16
• Study First Posted: 2006-11-20
• Primary Completion: 2007-11
• Study Completion: 2008-08
• Status Verified: 2014-02
• Results First Submitted: 2014-02-14
• Results First Submitted QC: 2014-02-14
• Last Update Submitted: 2014-02-14
• Results First Posted: 2014-04-01
• Last Update Posted: 2014-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 412

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: DTaP IPV Hep B PRP T + Prevnar™	DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines	-
Group 2: Infanrix hexa™ + Prevnar™	DTaP-HB-IPV and Pneumococcal polysaccharide vaccines	-

Primary Outcome Measures

Name	Time	Method
Number of Participants Achieving Seroprotection Against Hepatitis B and Haemophilus Influenzae Type b Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™	Day 150 post-dose 1	Anti-Hepatitis B antibodies were measured using chemiluminescence detection technology; seroprotection was defined as a titer ≥ 10 mIU/mL. Anti-Haemophilus influenzae type b (anti-PRP) antibodies were measured by radioimmunoassay; seroprotection was defined as a titer ≥ 0.15 µg/mL.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Seroprotection Against Diphtheria and Tetanus Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™	Day 150 post-dose 1	Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-Tetanus antibodies were measured by an indirect enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined for both as a titer ≥ 0.01 IU/mL.
Number of Participants With Seroprotection Against Poliovirus Types 1, 2, and 3 Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™	Day 150 post-dose 1	Anti poliovirus types 1, 2, and 3 antibodies were measured by neutralization assay. Seroprotection was defined as a titer ≥ 8 1/dil
Number of Participants With Seroconversion Against Pertussis Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™	Day 150 post-dose 1	Anti pertussis toxoid (PT) and anti-filamentous hemagglutinin (FHA) antibodies were measured by enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as ≥ 4 fold increase over baseline.
Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™	Day 150 post-dose 1	Anti-hepatitis B antibodies were measured using chemiluminescence detection technology. Anti-Haemophilus influenzae type b (anti-PRP) antibodies were measured by radioimmunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus and anti-Pertussis by enzyme-linked immunosorbent assay (ELISA), and anti-Polio by neutralization assay.
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™	Day 0 up to Day 7 post-vaccination	Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia, Vomiting, Crying, Somnolence, Anorexia, and Irritability Grade 3: Pain, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm.; Grade 3: Pyrexia, \>39°C; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying, \>3 hours; Somnolence, Sleeping most of the time or difficult to wake up; Anorexia, Refuses ≥3 feeds/meals or refuses most feeds/meals; and Irritability, Inconsolable.