Status:
COMPLETED
An Evaluation of PCV13 Vaccine Schedules, Comparing Impact of 2+1 vs 3+0 on Pneumococcal Carriage in Blantyre, Malawi
Lead Sponsor:
University of Liverpool
Collaborating Sponsors:
Malawi-Liverpool-Wellcome Trust Clinical Research Programme
Ministry of Health, Malawi
Conditions:
13-valent Pneumococcal Vaccine
Streptococcus Pneumoniae
Eligibility:
All Genders
15-40 years
Brief Summary
Pneumococcal conjugate vaccines (PCV) have been shown to be effective against invasive pneumococcal disease (IPD; including pneumococcal meningitis and sepsis) and all-cause mortality among young chil...
Detailed Description
STUDY TYPE: Pragmatic health center-based evaluation to compare effectiveness of a MoH-mandated structured PCV13 schedule change from 3+0 to 2+1 dosing in a high disease burden setting in Malawi PROBL...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- PCV13-vaccinated children, 15-24 months of age (schedule 2+1 or 3+1):
- Aged between 15-24 month
- Permanent resident in Blantyre District
- Parent/legal guardian consent for the child to have a NP swab taken
- Evidence of having received a full schedule of PCV13 vaccination recorded in the health passport and which schedule given
- PCV13-vaccinated children, 9 months of age (schedule 2+0 or 3+0):
- Aged 9 months
- Permanent resident in Blantyre District
- Parent/legal guardian consent for the child to have a NP swab taken
- Evidence of having received either a full 3+0 schedule or both primary doses (at approximately 6 and 14 weeks of age) of the 2+1 schedule of PCV13 vaccination recorded in the health passport
- PCV13-vaccinated children, 5-10 years of age (schedule 3+0):
- Aged between 5-10 years
- Parent/legal guardian consent for the child to have a NP swab taken
- If the child is ≥8 years old, child assent to have a NP swab taken
- Either verbal or documented evidence of having received primary immunization with PCV
- PCV13-unvaccinated HIV-infected adults on ART 18 - 40 years of age:
- • Aged 18-40 years
- EXCLUSION CRITERIA:
- For all participants:
- Current TB treatment
- Pneumonia hospitalization \<14 days before study enrolment
- Terminal illness
- For Children:
- No parental/legal guardian consent
- No child assent (children aged \>8 years old)
- Having received antibiotic treatment \<14 days before study enrolment
- For Adults:
- Unable or unwilling to provide consent
- Prior vaccination with pneumococcal vaccine
Exclusion
Key Trial Info
Start Date :
July 21 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 16 2024
Estimated Enrollment :
3507 Patients enrolled
Trial Details
Trial ID
NCT04078997
Start Date
July 21 2019
End Date
February 16 2024
Last Update
September 4 2025
Active Locations (1)
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1
Malawi-Liverpool-Wellcome Research Programme
Blantyre, Chichiri, Malawi, P.O. Box 30096