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Clinical trial

A Phase I/II, Double-Blind, Randomized, Active Controlled, Multi-centric Clinical Trial to Assess the Reactogenicity, Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib) in Comparison With HEXASIIL® (DTwP-HepB-IPV-Hib) Vaccine in Healthy Toddlers and Infants.

NCT07855172 is registered in ClinicalTrials.gov with Serum Institute of India Pvt. Ltd. as lead sponsor.

NCT NCT07855172
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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase I/II, Double-Blind, Randomized, Active Controlled, Multi-centric Clinical Trial to Assess the Reactogenicity, Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib) in Comparison With HEXASIIL® (DTwP-HepB-IPV-Hib) Vaccine in Healthy Toddlers and Infants.
Lead sponsor
Serum Institute of India Pvt. Ltd.
Phase
Phase 1/2
Overall status
Not yet recruiting
Start date
October 31, 2026
Completion date
October 31, 2027
Enrollment
186 (estimated)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

diptheria immunization, haemophilus influenzaetype b immunization, hepatitis b immunization, pertussis immunization, polio immunization, tetanus immunization