Immunogenicity and Safety of the DTaP-IPV (sanofi Pasteur Kitasato) Combined Vaccine (DD-687) given subcutaneously as a three-dose primary and booster vaccination versus commercially available DTaP (Kitasato) and Oral Polio Virus (OPV) Vaccines in Infants in Japa
Phase 3
- Conditions
- Prophylaxis of pertussis, diphtheria, tetanus, and poliomyelitis infection.
- Registration Number
- JPRN-jRCT2080221313
- Lead Sponsor
- DAIICHISANKYO Co.,Ltd., Sanofi Aventis KK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 374
Inclusion Criteria
starting at 3-68 (recommended 3-8) months of age
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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How does subcutaneous DTaP-IPV (DD-687) induce immune responses compared to DTaP and OPV in infants?
What are the comparative antibody titers and seroconversion rates of DTaP-IPV (DD-687) versus DTaP and OPV in Japanese infants?
Which neonatal immune biomarkers correlate with seroresponse to DTaP-IPV (DD-687) vaccination in Japan?
What adverse event profiles and management strategies differentiate subcutaneous DTaP-IPV (DD-687) from oral OPV in infant vaccination?
What alternative combination vaccines or polio vaccine strategies are being developed by Sanofi Pasteur and Daiichi Sankyo for pediatric use?