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The Effect of Fractional Doses of Pneumococcal Conjugate Vaccines on Immunogenicity and Carriage in Kenyan Infants

NCT03489018 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2100

Last updated 2024-11-12

No results posted yet for this study

Summary

Before the introduction of pneumonia vaccines in 2000, between 700,000 - 1 million children died each year as a result of infection with the bacteria Streptococcus pneumoniae and the resulting diseases, namely, meningitis, sepsis and pneumonia. Most of the deaths were in Africa and Asia. Where the vaccines have been introduced, they have been highly effective and have already reduced disease. However, at 10 USD per child, they are not affordable to most low-income countries without financial support from Gavi, the Vaccine Alliance.

This project aims to assess whether lower doses of the two commercially available pneumonia vaccines can protect Kenyan infants as well as the full dose. The results could be used to increase the affordability of the pneumonia vaccine, and enable delivery of the vaccine to continue in the absence of Gavi support.

Conditions

  • Pneumococcal Infection
  • Streptococcus Pneumoniae Infection
  • Invasive Pneumococcal Disease, Protection Against

Interventions

BIOLOGICAL

PCV10

Experimental arms will receive a lower dose of the intervention than the marketed dose.

BIOLOGICAL

PCV13

Experimental arms will receive a lower dose of the intervention than the marketed dose.

Sponsors & Collaborators

  • University College, London

    collaborator OTHER

  • KEMRI-Wellcome Trust Collaborative Research Program

    collaborator OTHER

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • National Institute of Health Research (NIHR) Mucosal Pathogens Research Unit (MPRU)

    collaborator UNKNOWN

  • Wellcome Trust

    collaborator OTHER

  • London School of Hygiene and Tropical Medicine

    lead OTHER

Principal Investigators

  • J. Anthony G Scott, DTMH FMedSci · London School of Hygiene & Tropical Medicine, Keppel Street, London

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-03-21
Primary Completion
2022-09-30
Completion
2024-11-01
FDA Drug
Yes

Countries

  • Kenya

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 NCT03489018 on ClinicalTrials.gov