drugset / Trial / NCT02961231
Evaluation of PCV Schedules in a Naive Population in Vietnam
Phase 4
Completed
18652 enrolled
Nagasaki University
London School of Hygiene and Tropical Medicine · collabMurdoch Childrens Research Institute · collabNational Institute of Hygiene and Epidemiology, Vietnam · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
The cost of pneumococcal conjugate vaccine use can be greatly reduced by making use of existing herd immunity to protect children against vaccine type pneumococci. The investigators will reduce the circulation of vaccine type pneumococci to low levels by PCV catch-up campaign; vaccinating all children less than 3 years of age with PCV, after which the investigators will evaluate the ability of a simplified two doses regimen and an alternative one dose regimen to prevent the reintroduction of vaccine type pneumococci compared to the WHO recommended 2 doses schedule.
Timeline
- Start
- 2016-10-01
- Primary completion
- 2020-11-30
- Completion
- 2023-12-31
Publications
- Background R. J. Hayes, L. H. Moulton, Cluster randomised trials (Chapman & Hall, 2009).
- Background Satzke C, Dunne EM, Porter BD, Klugman KP, Mulholland EK; PneuCarriage project group. The PneuCarriage Project: A Multi-Centre Comparative Study to Identify the Best Serotyping Methods for Examining Pneumococcal Carriage in Vaccine Evaluation Studies. PLoS Med. 2015 Nov 17;12(11):e1001903; discussion e1001903. doi: 10.1371/journal.pmed.1001903. eCollection 2015 Nov.
- Results Bogaert D, De Groot R, Hermans PW. Streptococcus pneumoniae colonisation: the key to pneumococcal disease. Lancet Infect Dis. 2004 Mar;4(3):144-54. doi: 10.1016/S1473-3099(04)00938-7.
- Results Feikin DR, Kagucia EW, Loo JD, Link-Gelles R, Puhan MA, Cherian T, Levine OS, Whitney CG, O'Brien KL, Moore MR; Serotype Replacement Study Group. Serotype-specific changes in invasive pneumococcal disease after pneumococcal conjugate vaccine introduction: a pooled analysis of multiple surveillance sites. PLoS Med. 2013;10(9):e1001517. doi: 10.1371/journal.pmed.1001517. Epub 2013 Sep 24.
- Results Vu HT, Yoshida LM, Suzuki M, Nguyen HA, Nguyen CD, Nguyen AT, Oishi K, Yamamoto T, Watanabe K, Vu TD. Association between nasopharyngeal load of Streptococcus pneumoniae, viral coinfection, and radiologically confirmed pneumonia in Vietnamese children. Pediatr Infect Dis J. 2011 Jan;30(1):11-8. doi: 10.1097/INF.0b013e3181f111a2.
- Quilty BJ, Toizumi M, Nguyen HAT, Le LT, Le HH, Iwasaki C, Takegata M, Kitamura N, Shah MM, Nation ML, Hinds J, Zandvoort KV, Ortika BD, Dunne EM, Satzke C, Do HT, Mulholland K, Dang DA, Flasche S, Yoshida LM. Sustained and indirect effects of PCV10 reduced-dose schedules on pneumococcal carriage in Viet Nam: a long-term follow-up of a cluster-randomised controlled trial. Lancet Infect Dis. 2026 May 27:S1473-3099(26)00172-6. doi: 10.1016/S1473-3099(26)00172-6. Online ahead of print.
- Yoshida LM, Toizumi M, Nguyen HAT, Quilty BJ, Lien LT, Hoang LH, Iwasaki C, Takegata M, Kitamura N, Nation ML, Hinds J, van Zandvoort K, Ortika BD, Dunne EM, Satzke C, Do HT, Mulholland K, Flasche S, Dang DA. Effect of a Reduced PCV10 Dose Schedule on Pneumococcal Carriage in Vietnam. N Engl J Med. 2024 Nov 28;391(21):1992-2002. doi: 10.1056/NEJMoa2400007.
- Yoshida LM, Flasche S, Mulholland K, Nguyen HA, Nguyen C, Toizumi M, Dang DA. Evaluation of the effect of reduced-dose pneumococcal conjugate vaccine schedules on vaccine serotype carriage in children and their caretakers in a naive population in Vietnam: Protocol for a cluster randomized non-inferiority trial. Gates Open Res. 2023 Jul 20;7:110. doi: 10.12688/gatesopenres.14742.1. eCollection 2023.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Synflorix | Vaccine | — | — |