Assess the Safety and Immunogenicity of PNEUMOSIL® Vaccine in Healthy Vietnamese Children, 6 Weeks to 24 Months of Age — PNEUMOSIL

Vaccine Preventable Disease Clinical Trial

Official title:
Assess 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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05140720
Study type	Interventional
Source	Vabiotech
Contact	Son T Vu, PhD
Phone	+84988350535
Email	vutungson1983@vmmu.edu.vn
Status	Not yet recruiting
Phase	N/A
Start date	January 25, 2022
Completion date	June 1, 2022

View Details

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