Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT05140720
Status:
UNKNOWN
Last Update Posted:
2021-12-01
First Post:
2021-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assess the Safety and Immunogenicity of PNEUMOSIL® Vaccine in Healthy Vietnamese Children, 6 Weeks to 24 Months of Age
Sponsor:
Vabiotech
Organization:
Study Overview
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:
UNKNOWN
Status Verified Date:
2021-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PNEUMOSIL
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: