Study of 10-valent Pneumococcal Conjugate Vaccine (Pneumosil) Administered in a 2+1 Schedule to Healthy Infants

Pneumonia, Pneumococcal Clinical Trial

Official title: A Phase 3, Randomized, Observer-Blind Study to Evaluate the Safety, Tolerability, Immunogenicity of Serum Institute of India's 10-Valent Pneumococcal Conjugate Vaccine (PNEUMOSIL®) Administered in a 2+1 Schedule to Healthy Infants in The Gambia

Status Completed

Clinical Trial Summary

The primary objectives of this study are to evaluate the immunogenicity (antibody response) and safety and tolerability of a 2-dose primary series and booster dose (2+1 schedule) of Pneumosil co-administered with routine pediatric vaccines in healthy infants in The Gambia.

Clinical Trial Description

This study will provide data necessary to evaluate the safety and immunogenicity of Pneumosil when administered in an alternative schedule to the 3 dose primary schedule (3+0) evaluated in the Phase 3 pivotal trial (VAC-056; NCT03197376) - namely in a 2 dose primary and booster (2+1) schedule - and compare immunogenicity to that of both currently licensed second-generation pneumococcal conjugate vaccines (Synflorix and Prevenar 13) administered in the same 2+1 schedule.

In this prospective, single center, randomized, active-controlled, observer-blind, Phase 3 descriptive study, 660 healthy Gambian pneumococcal conjugate vaccine (PCV)-naïve infants will be randomized 1:1:1 to receive 3 doses of either Pneumosil, Synflorix or Prevenar 13 at 6 weeks, 14 weeks and 9-10 months of age. Standard Expanded Program on Immunization (EPI) vaccinations in The Gambia will be given concomitantly with all 3 doses of study vaccine.

The booster vaccination window was extended up to 18 months of age due to a pause in the study due to the coronavirus disease 2019 (COVID-19) pandemic. The study schedule for participants is as follows:

• Age 6 weeks: First primary vaccination dose administered

• Age 14 weeks: Second primary vaccination dose administered (8 weeks after first primary dose)

• Age 18 weeks: Blood sample for immunogenicity testing (4 weeks after second primary dose)

• Age 9-18 months: Blood sample for immunogenicity testing and booster vaccination dose administered

• Age 10-19 months: Blood sample for immunogenicity testing (4 weeks after booster dose) ;

Related Conditions & MeSH terms

• Pneumonia, Pneumococcal

• NCT number: NCT03896477
• Study type: Interventional
• Source: PATH
• Status: Completed
• Phase: Phase 3
• Start date: July 18, 2019
• Completion date: December 17, 2020