Status:
COMPLETED
Persistence of Immunogenicity Following Reduced PCV Dosing Schedules in South African Children
Lead Sponsor:
University of Witwatersrand, South Africa
Conditions:
Pneumonia
Meningitis
Eligibility:
All Genders
3-5 years
Brief Summary
This study will evaluate the persistence of immunogenicity following a reduced dosing schedule of 10- or 13-valent Pneumococcal Conjugate Vaccine (PCV10, PCV13). This is the follow-up of a randomized ...
Detailed Description
Between 2017 and 2019, we conducted an open-labelled, randomized controlled trial to evaluate for non-inferiority in the post-booster serotype-specific geometric mean concentrations (GMC's) in childre...
Eligibility Criteria
Inclusion
- Children between and including the ages of 36 - 38 months of age at the time of first blood sampling;
- Subjects who previously participated in the PCV1+1 study and received the full study vaccination regime as per protocol;
- The parent or legal guardian of the child must be able and willing to provide written informed consent for all 3 visits and comply with all study requirements;
- The parent or legal guardian of the child must indicate the intention to remain in the study area for the duration of the trial - or be willing to bring the child for all visits.
Exclusion
- Receipt of any additional pneumococcal vaccine since the end of participation in the PCV1+1 study;
- Any known or suspected immunodeficiency condition which could affect immune response to vaccination, including living with HIV;
- Receipt of any immunoglobulins and/or blood products less than 6 months prior to blood sampling;
- Parent/legal guardian unable or unwilling to attend scheduled study visits.
Key Trial Info
Start Date :
February 14 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04275284
Start Date
February 14 2020
End Date
December 1 2022
Last Update
August 23 2024
Active Locations (1)
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1
Chris Hani Baragwanath Academic Hospital - DST/NRF VPD RMPRU
Soweto, Gauteng, South Africa, 2013