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

NCT04193215 | Completed Phase 3 DMC FDA Drug

• 2 other identifiers: V114-0322023-001146-11
• Study Type: interventional
• Target: 7,119
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

Acute Otitis Media (AOM)

Outcome Measures

Primary Outcomes (5)

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

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

  Up to ~36 months

• Percentage of Participants with Serious Adverse Events

  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.

  Up to ~36 months

• Percentage of Participants with Vaccine-Related Serious Adverse Events

  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.

  Up to ~36 months

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

  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.

  Up to ~36 months

• Percentage of Participants Who Died

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

  Up to ~36 months

Study Arms (2)

V114

EXPERIMENTAL

Participants will receive an intramuscular (IM) injection.

Biological: V114; Other: Pediatric vaccines

Control

OTHER

Other: Pediatric vaccines

Interventions

V114 BIOLOGICAL

IM injection

Also known as: VAXNEUVANCE™, Pneumococcal 15-Valent Conjugate Vaccine

V114

Pediatric vaccines OTHER

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

Control; V114

Eligibility Criteria

• Age: 42 Days - 90 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (13)

Chulalongkorn University ( Site 0008)

Bangkok, Bangkok, 10330, Thailand

Location

Phramongkutklao Hospital ( Site 0003)

Bangkok, Bangkok, 10400, Thailand

Location

Siriraj Hospital ( Site 0004)

Bangkok, Bangkok, 10700, Thailand

Location

Ramathibodi Hospital, Mahidol University ( Site 0009)

Rajthevee, Bangkok, 10400, Thailand

Location

Bhumibol Adulyadej Hospital ( Site 0013)

Sai Mai, Bangkok, 10220, Thailand

Location

Panyananthaphikkhu Chonprathan Medical Center ( Site 0014)

Pak Kret, Changwat Nonthaburi, 11120, Thailand

Location

Faculty of Medicine Thammasat Univ. ( Site 0007)

Khong Luang, Changwat Pathum Thani, 12120, Thailand

Location

Prince of Songkla University Faculty of Medicine ( Site 0005)

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

Maharaj Nakorn Chiang Mai Hospital ( Site 0001)

Chiang Mai, 50200, Thailand

Location

Chiang Rai Prachanuchro Hospital-Pediatrics ( Site 0015)

Chiang Rai, 57000, Thailand

Location

Srinagarind Hospital ( Site 0002)

Khon Kaen, 40002, Thailand

Location

Bamrasnaradura Infectious Disease Institute ( Site 0011)

Nonthaburi, 11000, Thailand

Location

Sappasit Prasong Hosptial-Pediatric ( Site 0016)

Ubon Ratchathani, 34000, Thailand

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 10, 2019
• Study Start: September 12, 2020
• Primary Completion: December 22, 2025
• Study Completion: December 22, 2025
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

TH (13)