Persistence of Immunogenicity Following Reduced PCV Dosing Schedules in South African Children
PCV1+1_FU
Evaluation of Persistence of Immunogenicity Following an Open-labelled, Randomized Controlled Trial Evaluating Non-inferiority of 1+1 Compared to 2+1 Dosing Schedules of 10-valent and 13-valent Pneumococcal Conjugate Vaccine in South Africa
1 other identifier
observational
600
1 country
1
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 controlled trial in which children received a single priming dose of PCV10 or PCV13 (at 6 or 14 weeks of age) followed by booster dose at 9 months of age (1+1 schedule), compared to a 2+1 PCV schedule (6, 14 weeks of age and 9 months of age).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2020
CompletedStudy Start
First participant enrolled
February 14, 2020
CompletedFirst Posted
Study publicly available on registry
February 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedAugust 23, 2024
August 1, 2024
2.8 years
February 14, 2020
August 20, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Serotype specific geometric mean antibody concentrations (GMC)
To evaluate persistence of vaccine-serotype specific GMCs at 3, 4 and 5 years of age between children receiving differing 1+1 dosing schedules compared to the 2+1 dosing schedule of the same vaccine formulation (i.e. PCV10 or PCV13).
3, 4 and 5 years of age
Secondary Outcomes (3)
Modified threshold of protection
3, 4 and 5 years of age
Comparison between 6-week and 14-week primary dose
3, 4 and 5 years of age
Colonization outcome
3, 4 and 5 years of age
Study Arms (6)
PCV10 1+1, 6 weeks & 9 months
Follow-up of children who were previously randomized to PCV10 (Synflorix 0.5ml injection) administered at 6 weeks and 9 months of age.
PCV13 1+1, 6 weeks & 9 months
Follow-up of children who were previously randomized to PCV13 (Prevnar 13, 0.5ml injection) administered at 6 weeks and 9 months of age.
PCV10 1+1, 14 weeks & 9 months
Follow-up of children who were previously randomized to PCV10 (Synflorix 0.5ml injection) administered at 14 weeks and 9 months of age.
PCV13 1+1, 14 weeks & 9 months
Follow-up of children who were previously randomized to PCV13 (Prevnar 13, 0.5ml injection) administered at 14 weeks and 9 months of age.
PCV10 2+1, 6&14 weeks & 9 months
Follow-up of children who were previously randomized to PCV10 (Synflorix 0.5ml injection) administered at 6 weeks, 14 weeks and 9 months of age.
PCV13 2+1, 6&14 weeks & 9 months
Follow-up of children who were previously randomized to PCV13 (Prevnar 13, 0.5ml injection) administered at 6 weeks, 14 weeks and 9 months of age.
Interventions
Eligibility Criteria
All participants who completed the PCV1+1 study and received all vaccines as specified per study protocol will be contacted to participate.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chris Hani Baragwanath Academic Hospital - DST/NRF VPD RMPRU
Soweto, Gauteng, 2013, South Africa
Related Publications (1)
Olwagen CP, Izu A, Van der Merwe L, Jose L, Koen A, Madhi SA. Single priming and a booster dose of 10-valent and 13-valent pneumococcal conjugate vaccine (PCV) maintains suppression of vaccine serotype colonization in South African children at 3, 4, and 5 years of age: a single-centre, open-labelled, randomized trial. Expert Rev Vaccines. 2024 Jan-Dec;23(1):1011-1019. doi: 10.1080/14760584.2024.2417856. Epub 2024 Oct 22.
PMID: 39417218DERIVED
Biospecimen
Serum and nasopharyngeal swabs
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shabir A Madhi, MD PhD
University of the Witwatersrand, South Africa
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
February 14, 2020
First Posted
February 19, 2020
Study Start
February 14, 2020
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
August 23, 2024
Record last verified: 2024-08