CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 18,652 enrolled
Drug / intervention
PCV 2p+1 +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02961231
NCT02961231Phase 4Completed

Evaluation of PCV Schedules in a Naive Population in Vietnam

Nagasaki University·interventional·Posted Nov 10, 2016·Updated Apr 19, 2024

In Brief

A Phase 4 clinical trial evaluating PCV 2p+1, PCV 3p+0, and 2 other interventions for Pneumonia, Pneumococcal. Completed, enrolled 18,652 participants across 1 site.

Detailed 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.

Study Details

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 10, 2016
Enrollment StartOct 1, 2016
Primary CompletionNov 30, 2020
Study CompletionDec 31, 2023
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 9.6 years ago

Interventions

PCV 2p+1biological

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

PCV 3p+0biological

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

PCV 1p+1biological

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

PCV 0p+1biological

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