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Evaluation of PCV Schedules in a Naive Population in Vietnam

NCT02961231 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 18652

Last updated 2024-04-19

No results posted yet for this study

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

Interventions

BIOLOGICAL

PCV 2p+1

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

BIOLOGICAL

PCV 3p+0

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

BIOLOGICAL

PCV 1p+1

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

BIOLOGICAL

PCV 0p+1

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

Sponsors & Collaborators

  • National Institute of Hygiene and Epidemiology, Vietnam

    collaborator OTHER

  • Murdoch Childrens Research Institute

    collaborator OTHER

  • London School of Hygiene and Tropical Medicine

    collaborator OTHER

  • Nagasaki University

    lead OTHER

Principal Investigators

  • LAYMYINT YOSHIDA, MBBS, PhD · Institute of Tropical Medicine, Nagasaki University, Nagasaki

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-01
Primary Completion
2020-11-30
Completion
2023-12-31

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02961231 on ClinicalTrials.gov