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New vaccine shows promise against childhood ear infections

NCT ID NCT04193215

Vaccine Sponsor: Merck Sharp & Dohme LLC 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 called V114 in over 7,000 healthy infants to see if it could prevent ear infections caused by certain pneumococcal bacteria. The vaccine was given alongside routine childhood shots. Researchers tracked how many babies got vaccine-type ear infections and monitored for serious side effects. The goal was to see if V114 works better than no V114 at preventing these infections.

What this could mean

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

Active substance
V114 (Pneumococcal 15-Valent Conjugate Vaccine)
What this could lead to
If successful, this vaccine could reduce the number of ear infections caused by certain pneumococcal bacteria in young children.
What could go wrong
This is a completed phase 3 trial, but results may not apply to all children or regions. Ear infections can still be caused by other germs not covered by the vaccine.

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

7,119 people

The number who actually took part.

Started

Sep 2020

Finished

Dec 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 90 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: * Is healthy (based on a review of medical history and physical examination) * Is male or female, approximately 2 months of age, from 42 days to 90 days of age Exclusion Criteria: * Was born prior to 37 weeks of gestation. * Has a history of invasive pneumococcal disease (IPD) (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease. * Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV), any component of the licensed pediatric vaccines to be administered concomitantly in the study, or any diphtheria toxoid-containing vaccine. * Has any contraindication to the concomitant study vaccines being administered in the study. * Has external auditory canal atresia/stenosis. * Has a known or suspected impairment of immunological function.

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Conditions

The condition(s) this trial relates to.

otitis media infectious otitis media prevention target

As listed by the trial registrant

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

Acute otitis media (AOM)

Contacts and locations

Locations

  • Bamrasnaradura Infectious Disease Institute ( Site 0011)

    Nonthaburi, 11000, Thailand

  • Bhumibol Adulyadej Hospital ( Site 0013)

    Sai Mai, Bangkok, 10220, Thailand

  • Chiang Rai Prachanuchro Hospital-Pediatrics ( Site 0015)

    Chiang Rai, 57000, Thailand

  • Chulalongkorn University ( Site 0008)

    Bangkok, Bangkok, 10330, Thailand

  • Faculty of Medicine Thammasat Univ. ( Site 0007)

    Khong Luang, Changwat Pathum Thani, 12120, Thailand

  • Maharaj Nakorn Chiang Mai Hospital ( Site 0001)

    Chiang Mai, 50200, Thailand

  • Panyananthaphikkhu Chonprathan Medical Center ( Site 0014)

    Pak Kret, Changwat Nonthaburi, 11120, Thailand

  • Phramongkutklao Hospital ( Site 0003)

    Bangkok, Bangkok, 10400, Thailand

  • Prince of Songkla University Faculty of Medicine ( Site 0005)

    Hat Yai, Changwat Songkhla, 90110, Thailand

  • Ramathibodi Hospital, Mahidol University ( Site 0009)

    Rajthevee, Bangkok, 10400, Thailand

  • Sappasit Prasong Hosptial-Pediatric ( Site 0016)

    Ubon Ratchathani, 34000, Thailand

  • Siriraj Hospital ( Site 0004)

    Bangkok, Bangkok, 10700, Thailand

  • Srinagarind Hospital ( Site 0002)

    Khon Kaen, 40002, Thailand

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