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-098) in Infants in Japan

Sanofi Pasteur, a Sanofi Company0 sites424 target enrollmentOctober 2014

ConditionsTetanus Diphtheria Pertussis Poliomyelitis Bacterial Meningitis

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Tetanus
Sponsor: Sanofi Pasteur, a Sanofi Company
Enrollment: 424
Primary Endpoint: Percentage of participants with anti-Diphtheria level ≥ 0.1 IU/mL post-dose 3
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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 Description

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.

Registry

clinicaltrials.gov

Start Date

October 2014

End Date

May 28, 2016

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sanofi Pasteur, a Sanofi Company

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Aged 2 months to 68 months inclusive (recommended 3 to 8 months for Groups A and B; 2 months for Group C) on the day of inclusion
•Informed consent form signed by the parent(s) or other legal representative
•Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria

•Fever ≥ 37.5°C (axillary temperature) on the day of inclusion
•Any serious disease whether acute or chronic
•Past or current medical history of Guillain-Barre syndrome, acute thrombocytopenic purpura or encephalopathy
•History of diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b infections
•History of a life threatening reaction to a vaccine containing the same substances of the study vaccine
•History of anaphylaxis to any of the study vaccine components
•Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis or Haemophilus influenzae type b infections with a trial vaccine or another vaccine
•Congenital or current acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
•Participation in another clinical trial preceding the trial inclusion
•Planned participation in another clinical trial during the present trial period

Outcomes

Primary Outcomes

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)

Secondary Outcomes

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.(Day 0 (post-vaccination) up to 21 days post each vaccination)
Geometric Mean Titer (GMT) of antibodies to vaccine antigens following vaccination(21 Days post-dose 3)
Percentage of participants with Seroprotection to vaccine antigens following vaccination(Day 0 (pre-vaccination ) and 21 Days post-dose 3)