CompletedPhase 3

V114 and Acute Otitis Media (V114-032/PNEU-ERA)

Thailand7,119 participantsStarted 2020-09-12

Plain-language summary

The primary objective is to evaluate V114 in the prevention of vaccine-type acute otitis media (VT-AOM) and the safety of V114 with respect to the proportion of participants with serious adverse events (SAEs) through completion of the study. The primary hypothesis is that V114 is superior to no V114 in preventing VT-AOM as assessed by the incidence of VT-AOM.

Who can participate

Age range

42 Days – 90 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants with a First Episode of Vaccine-Type Acute Otitis Media (VT-AOM) Caused by the Pneumococcal Serotypes Contained in V114

Timeframe: Up to ~36 months

Percentage of Participants with Serious Adverse Events

Timeframe: Up to ~36 months

Percentage of Participants with Vaccine-Related Serious Adverse Events

Timeframe: Up to ~36 months

Percentage of Participants Who Discontinued the Study due to Serious Adverse Events

Timeframe: Up to ~36 months

Percentage of Participants Who Died

Timeframe: Up to ~36 months

Trial details

NCT IDNCT04193215

SponsorMerck Sharp & Dohme LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-22

View on ClinicalTrials.gov More Acute Otitis Media (AOM) trials

Plain-language summary

Who can participate

Age range

42 Days – 90 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants with a First Episode of Vaccine-Type Acute Otitis Media (VT-AOM) Caused by the Pneumococcal Serotypes Contained in V114

Timeframe: Up to ~36 months

Percentage of Participants with Serious Adverse Events

Timeframe: Up to ~36 months

Percentage of Participants with Vaccine-Related Serious Adverse Events

Timeframe: Up to ~36 months

Percentage of Participants Who Discontinued the Study due to Serious Adverse Events

Timeframe: Up to ~36 months

Percentage of Participants Who Died

Timeframe: Up to ~36 months