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Phase 3 Study of 10-valent Pneumococcal Conjugate Vaccine (PNEUMOSIL) in Healthy Infants

NCT03197376 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2250

Last updated 2020-07-14

Study results available
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Summary

This study will examine the consistency of 3 batches of the Pneumosil vaccine by looking at the immune response in infants. In addition, the study will compare the immunogenicity of the Pneumosil vaccine to another WHO-prequalified vaccine, Synflorix.

Conditions

  • Pneumonia, Pneumococcal

Interventions

BIOLOGICAL

Pneumosil

10-Valent Pneumococcal Conjugate Vaccine

BIOLOGICAL

Synflorix

Pneumococcal conjugate vaccine (Non-Typeable Haemophilus influenzae (NTHi) protein D, diphtheria or tetanus toxoid conjugates) adsorbed

Sponsors & Collaborators

  • PATH

    lead OTHER

Principal Investigators

  • Ed Clarke · Medical Research Council (MRC) Unit, The Gambia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
8 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-21
Primary Completion
2018-06-06
Completion
2019-05-09

Countries

  • The Gambia

Study Locations

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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 NCT03197376 on ClinicalTrials.gov