Vabiotech
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.
Streptococcus Pneumonia
Vaccine Preventable Disease
PNEUMOSIL®
Not Applicable
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 Type : | Interventional |
Estimated Enrollment : | 300 participants |
Masking : | None (Open Label) |
Primary Purpose : | Prevention |
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 |
Actual Study Start Date : | January 25, 2022 |
Estimated Primary Completion Date : | February 28, 2022 |
Estimated Study Completion Date : | June 1, 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: 6 weeks - 6 months of age Group 1: Age group from 6 weeks - 6 months |
Biological: PNEUMOSIL® |
Experimental: 7 - 11 months of age Group 2: Age group from 7 - 11 months |
Biological: PNEUMOSIL® |
Experimental: 12 - 24 months of age Group 3: Age group from 12 - 24 months |
Biological: PNEUMOSIL® |
Ages Eligible for Study: | 6 Weeks to 24 Months |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.