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:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-25 @ 4:11 AM
NCT ID:
NCT05140720
Brief Summary:
The current study provides data necessary to evaluate the safety and immunogenicity of Serum Institute of India's PNEUMOSIL® \[Pneumococcal Polysaccharide Conjugate Vaccine Adsorbed (10-Valent)\] in Healthy Vietnamese Infants and Toddlers, 6 weeks to 24 months of age. This is an open label, prospective, bridging study.
Detailed Description:
In this open label, prospective, bridging study, 300 healthy infants and toddlers will be recruited into the study three pre-defined age groups:
Age group 1: From 6 weeks - 6 months Age group 2: From 7 months - 11 months Age group 3: From 12 months - 24 months
Study subjects will be vaccinated PNEUMOSIL® with the primary doses: Age group 1 with 3 doses, Age group 2 and Age group 3 with 2 doses.
Immunogenicity blood sample for Immunoglobulin G (IgG) will be taken in 35 subjects who completed primary dose series.
Study:
NCT05140720
Study Brief:
Protocol Section:
NCT05140720