NCT02274285

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 424 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 2 Months – 68 Months
• Healthy volunteers: Accepted

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.

Conditions

• Tetanus
• Diphtheria
• Pertussis
• Poliomyelitis
• Bacterial Meningitis

Interventions

Type	Name	Description
BIOLOGICAL	DTaP-IPV/Hib Combined vaccine	0.5 mL, Subcutaneously. 3 times, each given 3 to 8 weeks apart
BIOLOGICAL	DTaP-IPV vaccine and Hib vaccine	0.5 mL each, Subcutaneously, 3 times, each given 3 to 8 weeks apart
BIOLOGICAL	DTaP-IPV/Hib Combined vaccine	0.5 mL, Intramuscularly. 3 times, each given 4 to 8 weeks apart

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-05-28
• Completion: 2016-05-28
• First posted: 2014-10-24
• Last updated: 2022-04-25

Locations

12 sites across 1 country: Japan