NCT05140720

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

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: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Vabiotech · Industry
• Sex: All
• Age: 6 Weeks – 24 Months
• Healthy volunteers: Accepted

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.

Conditions

• Streptococcus Pneumonia
• Vaccine Preventable Disease

Interventions

Type	Name	Description
BIOLOGICAL	PNEUMOSIL®	Study subjects will be vaccinated PNEUMOSIL® with the primary doses as described below: Group 1: 3 doses, 4 to 8 week interval Group 2: 2 doses, dose interval \> 1 month Group 3: 2 doses, dose interval \> 2 months

Timeline

• Start date: 2022-01-25
• Primary completion: 2022-02-28
• Completion: 2022-06-01
• First posted: 2021-12-01
• Last updated: 2021-12-01