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

Phase 3

Active, not recruiting

• Conditions: Acute Otitis Media (AOM)
• Interventions: Biological: V114; Other: Pediatric vaccines

• Registration Number: NCT04193215
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2019-12-09
• Study First Posted: 2019-12-10
• Study Start: 2020-09-12
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Primary Completion: 2026-01-19
• Study Completion: 2026-01-19

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 7000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
V114	V114	Participants will receive an intramuscular (IM) injection.
V114	Pediatric vaccines	Participants will receive an intramuscular (IM) injection.
Control	Pediatric vaccines	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with Serious Adverse Events	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.
Number of Participants with a First Episode of Vaccine-Type Acute Otitis Media (VT-AOM) Caused by the Pneumococcal Serotypes Contained in V114	Up to ~36 months	The number of participants with VT-AOM will be presented.
Percentage of Participants with Vaccine-Related Serious Adverse Events	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.
Percentage of Participants Who Discontinued the Study due to Serious Adverse Events	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.
Percentage of Participants Who Died	Up to ~36 months	The percentage of participants who died from any cause during the study will be assessed.

Trial Locations

Locations (13)

Panyananthaphikkhu Chonprathan Medical Center ( Site 0014); 🇹🇭 Pak Kret, Nonthaburi, Thailand

Bhumibol Adulyadej Hospital ( Site 0013); 🇹🇭 Sai Mai, Krung Thep Maha Nakhon, Thailand

Sappasit Prasong Hosptial-Pediatric ( Site 0016); 🇹🇭 Ubon Ratchathani, Thailand

Siriraj Hospital ( Site 0004); 🇹🇭 Bangkok, Krung Thep Maha Nakhon, Thailand

Phramongkutklao Hospital ( Site 0003); 🇹🇭 Bangkok, Krung Thep Maha Nakhon, Thailand

Ramathibodi Hospital, Mahidol University ( Site 0009); 🇹🇭 Rajthevee, Krung Thep Maha Nakhon, Thailand

Bamrasnaradura Infectious Disease Institute ( Site 0011); 🇹🇭 Nonthaburi, Thailand

Chulalongkorn University ( Site 0008); 🇹🇭 Bangkok, Krung Thep Maha Nakhon, Thailand

Faculty of Medicine Thammasat Univ. ( Site 0007); 🇹🇭 Khong Luang, Pathum Thani, Thailand

Maharaj Nakorn Chiang Mai Hospital ( Site 0001); 🇹🇭 Chiang Mai, Thailand

Chiang Rai Prachanuchro Hospital-Pediatrics ( Site 0015); 🇹🇭 Chiang Rai, Thailand

Srinagarind Hospital ( Site 0002); 🇹🇭 Khon Kaen, Thailand

Prince of Songkla University Faculty of Medicine ( Site 0005); 🇹🇭 Hat Yai, Songkhla, Thailand