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Simple vaccine timing could save thousands of newborns

NCT ID NCT04658680

Prevention Sponsor: Bandim Health Project Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether giving the BCG vaccine (normally given for tuberculosis) at the very first health visit after birth can lower the chance of death in the first 42 days of life. Over 22,000 infants in rural Guinea-Bissau are taking part. Some health centers will offer BCG every day, while others stick to the usual weekly schedule. The goal is to see if earlier vaccination reduces deaths by 25%.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BCG vaccine (live attenuated Mycobacterium bovis)
What this could lead to
If it works, this simple change in vaccine timing could prevent many infant deaths in high-risk areas.
What could go wrong
This is a single trial in rural Guinea-Bissau; results may not apply elsewhere. The 25% reduction is a hypothesis, not guaranteed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 22,800 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2021

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 day to 42 days

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * All children registered during pregnancy in Oio, Biombo or Farim by CHWs or the BHP HDSS Exclusion Criteria: * Children, who have died within 1 day after birth * Children born outside Oio, Biombo and Farim health regions

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Conditions

The condition(s) this trial relates to.

Infant Death

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BCG Infant mortality

Contacts and locations

Locations

  • Bandim Health Project

    Bissau, Guinea-Bissau

More trials for these conditions

Other studies related to the condition(s) this trial covers.