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Clinical Trials/ISRCTN15056916
ISRCTN15056916
Active, not recruiting
Phase 4

A cluster-randomised, non-inferiority trial of the impact of a two-dose compared to a three-dose schedule of pneumococcal conjugate vaccine in rural Gambia.

ondon School of Hygiene & Tropical Medicine0 sites50,000 target enrollmentNovember 15, 2018

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Streptococcus pneumoniae disease and pneumococcal colonisation
Sponsor
ondon School of Hygiene & Tropical Medicine
Enrollment
50000
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

2022 Protocol article in https://doi.org/10.1186/s13063-021-05964-5 (added 24/05/2022)

Registry
who.int
Start Date
November 15, 2018
End Date
May 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
ondon School of Hygiene & Tropical Medicine

Eligibility Criteria

Inclusion Criteria

  • 1\. Resident in the study area
  • 2\. Children aged 6 weeks to 365 days will be eligible to receive the intervention
  • 3\. Children aged 2 weeks to 59 months will be eligible for measurement of the primary endpoint and disease endpoints by disease surveillance

Exclusion Criteria

  • 1\. Intent to move out of the study area before 4 months of age
  • 2\. Aged over 364 days
  • 3\. Contraindication to vaccination with PCV13, including severe hypersensitivity to a previous dose of PCV13

Outcomes

Primary Outcomes

Not specified

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