CompletedPhase 4

Evaluation of PCV Schedules in a Naive Population in Vietnam

Vietnam18,652 participantsStarted 2016-10-01

Plain-language 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.

Who can participate

Age range

2 Months – 36 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: All children living in the intervention communes in Nha Trang city, whose parents or guardian give informed consent will be eligible to receive PCV in accordance with their age. Exclusion Criteria: Children who are not fit enough to receive national vaccination program vaccine for health reason (eg.fever, currently under medication due to illness such as pneumonia, diarrhea, etc) in accordance with Vietnam national immunization guidelines. This will be decided by the medical doctor in charge of the vaccination at commune health center in accordance with Vietnamese guideline.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

vaccine type pneumococcal carriage

Timeframe: up to 60 months after PCV intervention

Trial details

NCT IDNCT02961231

SponsorNagasaki University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-11-30

View on ClinicalTrials.gov More Pneumonia, Pneumococcal trials