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Completed

NCT Number: NCT04193215

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

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.

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Key information

Conditions

Acute Otitis Media (AOM) Ear Diseases Otitis Otitis Media Otorhinolaryngologic Diseases

Age range

42 day–90 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chulalongkorn University ( Site 0008), Bangkok, Thailand

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

V114

Biological

IM injection

Other names: VAXNEUVANCE™, Pneumococcal 15-Valent Conjugate Vaccine

Pediatric vaccines

Other

Standard of care vaccines administered according to the local recommended schedule.

Primary outcomes

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

    Time frame: Up to ~36 months

    The number of participants with VT-AOM will be presented.

  2. Percentage of Participants with Serious Adverse Events

    Time frame: Up to ~36 months

    A serious adverse event (SAE) is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.

  3. Percentage of Participants with Vaccine-Related Serious Adverse Events

    Time frame: Up to ~36 months

    A serious adverse event (SAE) is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.

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

    Time frame: Up to ~36 months

    A serious adverse event (SAE) is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.

  5. Percentage of Participants Who Died

    Time frame: Up to ~36 months

    The percentage of participants who died from any cause during the study will be assessed.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Study of V114 and Acute Otitis Media in Children (PNEU-ERA)

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Dec 10, 2019
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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