Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2025-12-24 @ 2:06 PM
NCT ID:
NCT04429295
Brief 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
Detailed 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:
NCT04429295
Study Brief:
Protocol Section:
NCT04429295