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New 20-Strain pneumonia vaccine shows promise for infants

NCT ID NCT05512819

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a new vaccine (20vPnC) that protects against 20 types of pneumococcal bacteria, which can cause pneumonia and meningitis. Over 500 healthy infants in India and Taiwan received either the new vaccine or an existing one (13vPnC) as a series of four shots. Researchers monitored safety and immune responses for about 15 months.

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
What this could lead to
If successful, this vaccine could protect infants against 20 types of pneumococcal bacteria, reducing serious illnesses like pneumonia and meningitis.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The vaccine may cause side effects like fever or swelling, and its long-term effectiveness is still being studied.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

541 people

The number who actually took part.

Started

Sep 2022

Finished

Sep 2025

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.

Ages

42 to 84 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: * Male or female infants born at ≥36 weeks of gestation and approximately 2 months of age at the time of consent * Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study * Weight of 3.0 kg or greater at the time of randomization Exclusion Criteria: * History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of 13vPnC, 20vPnC, or any other diphtheria toxoid-containing vaccine. * Major known congenital malformation or serious chronic disorder * Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study intervention administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study * Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • BGS Global Institute of Medical Sciences (BGSGIMS)

    Bangalore, Karnataka, 560060, India

  • Bharati Vidyapeeth {Deemed to be University) Medical College Hospital & Research Centre

    Pune, Maharashtra, 411043, India

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333, Taiwan

  • Hsinchu Mackay Memorial Hospital

    Hsinchu, Hsinchu, 30071, Taiwan

  • Institute of Child Health

    Kolkata, West Bengal, 700017, India

  • Jawahar Lal Nehru Medical College

    Ajmer, Rajasthan, 305001, India

  • Mackay Memorial Hospital

    Taipei, 10449, Taiwan

  • Maulana Azad Medical College and Associated with Lok Nayak Hospital

    New Delhi, National Capital Territory of Delhi, 110002, India

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • Nirmal Hospital Pvt Ltd.

    Surat, Gujarat, 395002, India

  • Taichung Veterans General Hospital

    Taichung, 407219, Taiwan

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