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

NCT05140720 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2021-12-01

No results posted yet for this study

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.

Conditions

  • Streptococcus Pneumonia
  • Vaccine Preventable Disease

Interventions

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

Sponsors & Collaborators

  • Vietstar Biomedical Research

    collaborator INDUSTRY

  • Vabiotech

    lead INDUSTRY

Principal Investigators

  • Son T Vu, PhD · Vietnam Military Medicine University

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
24 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-25
Primary Completion
2022-02-28
Completion
2022-06-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05140720 on ClinicalTrials.gov