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Clinical Trial Summary

Primary Objective: To demonstrate the non-inferiority of the SHAN6™ vaccine to the licensed SHAN5™ given with bOPV and IPV vaccines when coadministered with PCV and ORV Secondary Objective: - To describe the immunogenicity profile of the SHAN6™ vaccine 3-dose primary infant vaccination and that of the control vaccines (SHAN5™ given with bOPV and IPV) - To describe the immune response to co-administered ORV-1 (Rotarix™) in a subset of participants from each group - To describe the immune response to co-administered PCV-13 (Prevnar 13®) in a subset of participants from each group - To describe the persistence of the antibodies against SHAN6™ antigens following a 3-dose primary series of SHAN6™ or SHAN5™ given with bOPV and IPV - To describe the immunogenicity profile of SHAN6™ 28 days after the single booster dose of SHAN6™ - To describe the safety profile of the SHAN6™ vaccine and the control vaccines (SHAN5™ given with bOPV and IPV), when administered concomitantly with routine pediatric vaccines


Clinical Trial Description

The duration of each participant's active participation in the study will be approximately 14-17 months (416-506 days) in addition to the 2 MedDRA terms: Polio immunisation 10054175 Hepatitis B immunisation 10054181 Haemophilus influenzae type B immunisation 10069533 Tetanus immunisation 10054131 Rotavirus immunisation 10076886 Pneumococcal immunisation 10069578 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04429295
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 3
Start date June 28, 2020
Completion date November 20, 2021

See also
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Completed NCT04300192 - Study to Evaluate the Immune Response After Booster Vaccination With Tdap-IPV Vaccine (Against Tetanus, Diphtheria, Pertussis and Poliomyelitis) in Children Who Received Different Pertussis Primary Vaccine Regimens in Republic of South Africa Phase 4
Completed NCT03589768 - Study on the Safety and Immunogenicity of Boostrix Vaccine in Pregnant Malian Women and Their Infants Phase 2