Evaluation of PCV Schedules in a Naive Population in Vietnam

NCT02961231 | Completed Phase 4 DMC

• 1 other identifier: OPP1139859
• Study Type: interventional
• Target: 18,652
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pneumonia, Pneumococcal

Keywords

Pneumococcal conjugate vaccine; Herd immunity; Reduced dosing schedule

Outcome Measures

Primary Outcomes (1)

• vaccine type pneumococcal carriage

  Vaccine type pneumococcal carriage among children receiving different PCV dose will be investigated yearly. Non-inferiority of 1p+1 dose will be compared with those receiving 2p+1/3p+0 groups.

  up to 60 months after PCV intervention

Study Arms (4)

PCV 2p+1

ACTIVE COMPARATOR

PCV 2p+1 schedule: WHO recommended 2 primary at 2, 4 months and a booster dose at 12 month

Biological: PCV 2p+1

PCV 3p+0

ACTIVE COMPARATOR

PCV 3p+0 schedule: WHO recommended 3 primary doses at 2, 3 and 4 months

Biological: PCV 3p+0

PCV 1p+1

EXPERIMENTAL

PCV 1p+1 schedule: one primary dose at 2 month and a booster at 12 month

Biological: PCV 1p+1

PCV 0p+1

EXPERIMENTAL

PCV 0p+1 schedule: no primary dose, only a booster at 12 month

Biological: PCV 0p+1

Interventions

PCV 2p+1 BIOLOGICAL

introduction of PCV in a reduced dosing 2p+1 schedule

Also known as: Synflorix

PCV 2p+1

PCV 3p+0 BIOLOGICAL

introduction of PCV in a reduced dosing 3p+0 schedule

Also known as: Synflorix

PCV 3p+0

PCV 1p+1 BIOLOGICAL

introduction of PCV in a reduced dosing 1p+1 schedule

Also known as: Synflorix

PCV 1p+1

PCV 0p+1 BIOLOGICAL

introduction of PCV in a reduced dosing 0p+1 schedule

Also known as: Synflorix

PCV 0p+1

Eligibility Criteria

• Age: 2 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

Sponsors & Collaborators

• Nagasaki University: lead
• National Institute of Hygiene and Epidemiology, Vietnam: collaborator
• Murdoch Childrens Research Institute: collaborator
• London School of Hygiene and Tropical Medicine: collaborator

Study Sites (1)

Commune Health Centers

Nha Trang, Khanh Hoa, Vietnam

Location

Related Publications (7)

• 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.

  PMID: 26575033 BACKGROUND

• 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.

  PMID: 14998500 RESULT

• 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.

  PMID: 24086113 RESULT

• 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.

  PMID: 20686433 RESULT

• 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.

  PMID: 39602629 DERIVED

• 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.

  PMID: 37780234 DERIVED

MeSH Terms

Conditions

Pneumonia, Pneumococcal

Interventions

PHiD-CV vaccine

Condition Hierarchy (Ancestors)

Pneumococcal Infections; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia, Bacterial; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• LAYMYINT YOSHIDA, MBBS, PhD

  Institute of Tropical Medicine, Nagasaki University, Nagasaki

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 43068 children participated in the PCV vaccination activity during the study period. A total of 18652 children were enrolled in the pneumococcal carriage surveys to evaluate the non-inferiority of VT reduction in 1p+1, 0p+1 vs 2p+1 and 3p+0 arms.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Pediaric Infectious Diseases, Institute of Tropical Medicine

Study Record Dates

• First Submitted: November 1, 2016
• First Posted: November 10, 2016
• Study Start: October 1, 2016
• Primary Completion: November 30, 2020
• Study Completion: December 31, 2023
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

VN (1)