drugset / Trial / NCT02943902
Reduced PCV Dosing Schedules in South African Infants
Phase 3
Completed
600 enrolled
University of Witwatersrand, South Africa
University College, London · collab
RandomizedParallel-groupOpen-labelPrevention
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).
Timeline
- Start
- 2017-01-09
- Primary completion
- 2019-02-26
- Completion
- 2019-02-26
Publications
- 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.
- Mutsaerts 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.
- Olwagen 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.
- Madhi 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Prevnar 13 | Vaccine | 0.5 ml | — |
| Subject | Synflorix | Vaccine | 0.5 ml | — |