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

NCT ID: NCT04193215

Last Updated: 2026-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

7119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-12

Study Completion Date

2025-12-22

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Otitis Media (AOM)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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V114

Participants will receive an intramuscular (IM) injection.

Group Type EXPERIMENTAL

V114

Intervention Type BIOLOGICAL

IM injection

Pediatric vaccines

Intervention Type OTHER

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

Control

Group Type OTHER

Pediatric vaccines

Intervention Type OTHER

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

Interventions

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V114

IM injection

Intervention Type BIOLOGICAL

Pediatric vaccines

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

Intervention Type OTHER

Other Intervention Names

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VAXNEUVANCE™ Pneumococcal 15-Valent Conjugate Vaccine

Eligibility Criteria

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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.
Minimum Eligible Age

42 Days

Maximum Eligible Age

90 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Chulalongkorn University ( Site 0008)

Bangkok, Bangkok, Thailand

Site Status

Phramongkutklao Hospital ( Site 0003)

Bangkok, Bangkok, Thailand

Site Status

Siriraj Hospital ( Site 0004)

Bangkok, Bangkok, Thailand

Site Status

Ramathibodi Hospital, Mahidol University ( Site 0009)

Rajthevee, Bangkok, Thailand

Site Status

Bhumibol Adulyadej Hospital ( Site 0013)

Sai Mai, Bangkok, Thailand

Site Status

Panyananthaphikkhu Chonprathan Medical Center ( Site 0014)

Pak Kret, Changwat Nonthaburi, Thailand

Site Status

Faculty of Medicine Thammasat Univ. ( Site 0007)

Khong Luang, Changwat Pathum Thani, Thailand

Site Status

Prince of Songkla University Faculty of Medicine ( Site 0005)

Hat Yai, Changwat Songkhla, Thailand

Site Status

Maharaj Nakorn Chiang Mai Hospital ( Site 0001)

Chiang Mai, , Thailand

Site Status

Chiang Rai Prachanuchro Hospital-Pediatrics ( Site 0015)

Chiang Rai, , Thailand

Site Status

Srinagarind Hospital ( Site 0002)

Khon Kaen, , Thailand

Site Status

Bamrasnaradura Infectious Disease Institute ( Site 0011)

Nonthaburi, , Thailand

Site Status

Sappasit Prasong Hosptial-Pediatric ( Site 0016)

Ubon Ratchathani, , Thailand

Site Status

Countries

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Thailand

Related Links

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https://merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

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V114-032

Identifier Type: OTHER

Identifier Source: secondary_id

2023-001146-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V114-032

Identifier Type: -

Identifier Source: org_study_id

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