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Could a simple vaccine cut infant deaths? trial investigates

NCT ID NCT02504203

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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether giving the BCG vaccine (normally given later) right after birth could reduce deaths in babies under 2 months old. Over 2,300 newborns in rural and urban areas took part. The trial was stopped early, so we don't have final answers yet.

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 (Bacillus Calmette-Guérin)
What this could lead to
If it works, giving BCG earlier could save many newborn lives in areas with high infant mortality.
What could go wrong
The trial was terminated early, so results are limited. The effect may vary by setting and not be as strong as hoped.

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

2,332 people

The number who actually took part.

Start date

Nov 2015

Finished

Jun 2021

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

Up to 72 hours

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 will be eligible for the study provided they have not yet received BCG at the date of the home visit. Exclusion Criteria: * Children born outside the cluster, and returning more than 72 hours after the delivery * Children that the nurse evaluates to die within the next 24 hours.

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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.