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New vaccine safety check for infants: PREVENAR 20 under Real-World scrutiny

NCT ID NCT06622109

Vaccine Sponsor: Pfizer 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study monitors the safety of the PREVENAR 20 vaccine in 1,100 infants aged 2 to 6 months in Japan. Infants receive four doses as part of routine care, and researchers track any side effects. The goal is to ensure the vaccine is safe for widespread use.

What this could mean

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

Active substance
20-valent Pneumococcal Conjugate Vaccine (PREVENAR 20)
What this could lead to
If successful, this study will confirm that PREVENAR 20 is safe for infants, supporting its routine use to prevent pneumococcal disease.
What could go wrong
This is an observational safety study, not a test of effectiveness. Side effects may still occur, and results may not apply outside Japan.

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.

Participants

1,100 people

The number who actually took part.

Started

Nov 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Infants aged 2 months, inclusive, to 7 months, exclusive who PREVENAR 20 for the first time.

Ages

2 to 6 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: 1. Infants aged 2 months, inclusive, to 7 months, exclusive 2. Those without a history of pneumococcal vaccination including PREVENAR 20 3. Those who are expected to receive 4 doses 4. Those whose parent or legal guardian understands the details of the study and provides consent to provision of information collected in the study to third parties and use of the information for other purposes. Exclusion Criteria:There are no exclusion criteria for this study.

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Conditions

The condition(s) this trial relates to.

pneumococcal infection prevention target

As listed by the trial registrant

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

Pneumococcal disease

Contacts and locations

Locations

  • Pfizer

    Tokyo, 151-8589, Japan

More trials for these conditions

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