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 ]
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