Clinical Trial: DTaP-IPV/Hib Vaccine Primary & Booster Vaccinations Versus Co-administration of DTaP-IPV and Hib Vaccine in Japanese Infants

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Immunogenicity and Safety of the DTaP-IPV/Hib Vaccine SP0204) Given as Three-dose Primary and One-dose Booster Vaccinations Versus Co-administration of DTaP-IPV Vaccine (DD-687) and Hib Vaccine (DF-09

Brief Summary:

Primary objective:

  • To demonstrate the non-inferiority in terms of seroprotection rates (Hib antigen (PRP), Diphtheria, Tetanus, and Pertussis antigens (PT and FHA), and polio types 1, 2 and 3 antigens) of investigational arm (Group A: DTaP-IPV/Hib) versus control arm (Group B: DTaP-IPV and Hib vaccines administered at separate sites), one month after the primary vaccination (all antigens).

Secondary objectives:

  • To describe immune responses against all vaccine antigens with no pre-specified hypothesis, and at all time points (pre-dose 1, post-dose 3, pre-dose 4 and post-dose 4) in the two study groups (Group A and Group B).
  • To describe the safety after each dose of each vaccine in the two study groups (Group A and Group B).
  • To describe immune responses against all vaccine antigens with no pre-specified hypothesis, and at all time points (pre-dose 1, post-dose 3, pre-dose 4 and post-dose 4 (Group C)

Detailed Summary:

Participants will be enrolled in two steps (Cohort 1 and Cohort 2). Step one will enroll Cohort 1 made of 40 participants randomized in two groups with a 1:1 ratio.

After review of the local and systemic adverse events occurring during the 7 Days following the first dose administered in these subjects, 2nd vaccination of Cohort 1 participants will resume and enrollment of the participants of Cohort number 2 will start. Step two will enroll Cohort 2 made of subjects randomized in two groups with a 1:1 ratio.

A sub-study Group C will be enrolled and will receive the vaccine by intramuscular route.


Sponsor: Sanofi Pasteur, a Sanofi Company

Current Primary Outcome: Percentage of participants with anti-Diphtheria level ≥ 0.1 IU/mL post-dose 3 [ Time Frame: 21 Days post-dose 3 ]

Anti-Diphtheria antibody titers will be assayed by neutralization test on Vero cells culture in comparison to the WHO equine antitoxin standard (seroneutralization)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Percentage of participants with Seroprotection to vaccine antigens following vaccination [ Time Frame: Day 0 (pre-vaccination ) and 21 Days post-dose 3 ]
    Seroprotection is defined as: percentage of participants with anti-Diphtheria and anti Tetanus antibody levels ≥0.01, ≥0.1 and ≥1.0 IU/mL
  • Geometric Mean Titer (GMT) of antibodies to vaccine antigens following vaccination [ Time Frame: 21 Days post-dose 3 ]
    Anti-Diphtheria antibody titers will be assayed by neutralization test on Vero cells culture in comparison to the WHO equine antitoxin standard (seroneutralization)
  • Information concerning the safety in terms of solicited injection site and systemic reactions, unsolicited adverse events, and serious adverse events post vaccination with DTaP IPV/Hib vaccine. [ Time Frame: Day 0 (post-vaccination) up to 21 days post each vaccination ]
    Solicited injection site reactions: Tenderness, Erythema, Swelling and Induration; Solicited Systemic Reactions: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost and Irritability.


Original Secondary Outcome: Same as current

Information By: Sanofi

Dates:
Date Received: October 22, 2014
Date Started: October 2014
Date Completion: June 2017
Last Updated: April 25, 2017
Last Verified: April 2017