Reduced PCV Dosing Schedules in South African Infants
PCV1+1
An Open-labeled, Randomized Controlled Trial Evaluating for Non-inferiority of 1+1 Compared to 2+1 Dosing Schedules of 10-valent and 13-valent Pneumococcal Conjugate Vaccine (PCV) in South African Children
1 other identifier
interventional
600
1 country
2
Brief Summary
This study will evaluate the immunogenicity of a reduced dosing schedule of Pneumococcal Conjugate vaccine (PCV) PCV10 and PCV13, in which children will receive a primary dose at either 6 or 14 weeks of age, followed by a booster dose at 9 months of age (1+1 schedule), and compare this immune response to those who receive a two dose primary series (at 6 and 14 weeks of age) and booster dose at 9-months (2+1 schedule).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2017
2 active sites
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
October 21, 2016
CompletedFirst Posted
Study publicly available on registry
October 25, 2016
CompletedStudy Start
First participant enrolled
January 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 26, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 26, 2019
CompletedDecember 9, 2019
December 1, 2019
2.1 years
October 21, 2016
December 6, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
serotype specific geometric mean antibody concentrations (GMC) one month following the booster dose
The serotype-specific GMC measured 1 month after the 9-month booster dose for each 1+1 vaccine group and comparing it to the 2+1 group of the same vaccine
1 month post booster vaccine
Secondary Outcomes (1)
Immunogenicity: percentage of children with vaccine-serotype specific serum IgG antibody concentration above the WHO-defined putative threshold for protection (≥0.35 µg/mL) at 9 months of age, prior to the booster dose of differing 1+1 dosing schedules
9 months of age
Study Arms (6)
Group 1a (1+1, 6 weeks)
EXPERIMENTALPCV10 (Synflorix 0.5ml injection) will be administered at 6 weeks and 9 months of age
Group 1b (1+1, 6 weeks)
EXPERIMENTALPCV13 (Prevenar 13, 0.5ml injection) will be administered at 6 weeks and 9 months of age
Group 2a (1+1, 14 weeks)
EXPERIMENTALPCV10 (Synflorix 0.5ml injection) will be administered at 14 weeks and 9 months of age
Group 2b (1+1, 14 weeks)
EXPERIMENTALPCV13 (Prevenar 13, 0.5ml injection) will be administered at 14 weeks and 9 months of age
Group 3a (2+1)
ACTIVE COMPARATORPCV10 (Synflorix 0.5ml injection) will be administered at 6 weeks, 14 weeks and 9 months of age, as per EPI schedule in South Africa
Group 3b (2+1)
ACTIVE COMPARATORPCV13 (Prevenar 13, 0.5ml injection) will be administered at 6 weeks, 14 weeks and 9 months of age, as per EPI schedule in South Africa
Interventions
PCV10 1+1, 6 weeks \& 9 months
PCV10 1+1, 14 weeks \& 9 months
PCV10 2+1, 6\&14 weeks \& 9 months
PCV13 1+1, 6 weeks \& 9 months
PCV13 1+1, 14 weeks \& 9 months
PCV13 2+1, 6\&14 weeks \& 9 months
Eligibility Criteria
You may qualify if:
- Signed informed consent by the parent/guardian of the child;
- Born to an HIV-uninfected women, based on testing undertaken as part of standard of care during the last trimester of pregnancy;
- Had not received any vaccine other than BCG and OPV (routinely given at birth) prior to enrolment;
- Birth weight \>2499g AND weight of child \>3.5 kg at time of proposed randomization;
- Aged 42-56 days of age at time of enrolment;
- Available for the duration of the study;
- Child is healthy based on medical history and physical examination of the study-staff.
You may not qualify if:
- Any clinically significant major congenital abnormalities;
- Previous hospitalization for a respiratory illness following discharge from hospital after birth;
- Receipt of any other investigational drug/vaccine. Co-enrollment into non-investigational studies, including epidemiology studies, is allowed;
- Any previous PCV vaccination;
- Known allergy to any of the vaccine components;
- Febrile illness (axillary temperature ≥37.8°C) at time of enrolment. These participants are eligible if the temperature resolves for at least 48 hours and they remain within the study defined window periods;
- Planned relocation to outside of the study area during up until age of 2 years;
- Receipt of blood transfusion or any other blood products (including immunoglobulins) since birth. Receipt of such products during the course of the study, will require withdrawal of the child from the study;
- History of confirmed pneumococcal disease since birth;
- Any known or suspected immunodeficiency condition which could affect immune response to vaccination.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Chris Hani Baragwanath Academic Hospital
Johannesburg, Gauteng, South Africa
Nrf/Dst Vpd Rmpru
Soweto, GP, 2055, South Africa
Related Publications (4)
Izu A, Mutsaerts EA, Olwagen C, Jose L, Koen A, Nana AJ, Cutland CL, Madhi SA. Serotype-specific serum immunoglobulin G at 18 months of age following one or two doses of a primary series of 10-valent or 13-valent pneumococcal conjugate vaccine and a booster dose at nine months of age: a randomized controlled study. Expert Rev Vaccines. 2025 Dec;24(1):121-127. doi: 10.1080/14760584.2025.2458179. Epub 2025 Jan 27.
PMID: 39865559DERIVEDMutsaerts EAML, van Cranenbroek B, Madhi SA, Simonetti E, Arns AJ, Jose L, Koen A, van Herwaarden AE, de Jonge MI, Verhagen LM. Impact of nutritional status on vaccine-induced immunity in children living in South Africa: Investigating the B-cell repertoire and metabolic hormones. Vaccine. 2024 May 22;42(14):3337-3345. doi: 10.1016/j.vaccine.2024.04.034. Epub 2024 Apr 17.
PMID: 38637212DERIVEDOlwagen CP, Izu A, Mutsaerts EAML, Jose L, Koen A, Downs SL, Van Der Merwe L, Laubscher M, Nana AJ, Moultrie A, Cutland CL, Dorfman JR, Madhi SA. Single priming and booster dose of ten-valent and 13-valent pneumococcal conjugate vaccines and Streptococcus pneumoniae colonisation in children in South Africa: a single-centre, open-label, randomised trial. Lancet Child Adolesc Health. 2023 May;7(5):326-335. doi: 10.1016/S2352-4642(23)00025-1. Epub 2023 Mar 16.
PMID: 36934731DERIVEDMadhi SA, Mutsaerts EA, Izu A, Boyce W, Bhikha S, Ikulinda BT, Jose L, Koen A, Nana AJ, Moultrie A, Roalfe L, Hunt A, Goldblatt D, Cutland CL, Dorfman JR. Immunogenicity of a single-dose compared with a two-dose primary series followed by a booster dose of ten-valent or 13-valent pneumococcal conjugate vaccine in South African children: an open-label, randomised, non-inferiority trial. Lancet Infect Dis. 2020 Dec;20(12):1426-1436. doi: 10.1016/S1473-3099(20)30289-9. Epub 2020 Aug 25.
PMID: 32857992DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shabir A Madhi, MD, PhD
University of Witwatersrand, South Africa
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Investigator
Study Record Dates
First Submitted
October 21, 2016
First Posted
October 25, 2016
Study Start
January 9, 2017
Primary Completion
February 26, 2019
Study Completion
February 26, 2019
Last Updated
December 9, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will share
The data will be made publically available, within one year of completion of the study to any investigators or BMGF nominated partners, who wish to use the data to address any specific questions not directly addressed under the study objectives and which the data would lend itself to