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

A Study of V114 and Acute Otitis Media in Children (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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Otitis Media (AOM)
• Intervention / Treatment: Biological: V114; Other: Pediatric vaccines

• Study Type: Interventional
• Enrollment (Estimated): 7000
• Phase: Phase 3

Contacts and Locations

Study Locations

• Thailand
  • Chiang Mai, Thailand, 50200
    • Maharaj Nakorn Chiang Mai Hospital ( Site 0001)
  • Chiang Rai, Thailand, 57000
    • Chiang Rai Prachanuchro Hospital-Pediatrics ( Site 0015)
  • Khon Kaen, Thailand, 40002
    • Srinagarind Hospital ( Site 0002)
  • Nonthaburi, Thailand, 11000
    • Bamrasnaradura Infectious Disease Institute ( Site 0011)
  • Ubon Ratchathani, Thailand, 34000
    • Sappasit Prasong Hosptial-Pediatric ( Site 0016)
  • Krung Thep Maha Nakhon
    • Bangkok, Krung Thep Maha Nakhon, Thailand, 10330
      • Chulalongkorn University ( Site 0008)
    • Bangkok, Krung Thep Maha Nakhon, Thailand, 10400
      • Phramongkutklao Hospital ( Site 0003)
    • Bangkok, Krung Thep Maha Nakhon, Thailand, 10700
      • Siriraj Hospital ( Site 0004)
    • Rajthevee, Krung Thep Maha Nakhon, Thailand, 10400
      • Ramathibodi Hospital, Mahidol University ( Site 0009)
    • Sai Mai, Krung Thep Maha Nakhon, Thailand, 10220
      • Bhumibol Adulyadej Hospital ( Site 0013)
  • Nonthaburi
    • Pak Kret, Nonthaburi, Thailand, 11120
      • Panyananthaphikkhu Chonprathan Medical Center ( Site 0014)
  • Pathum Thani
    • Khong Luang, Pathum Thani, Thailand, 12120
      • Faculty of Medicine Thammasat Univ. ( Site 0007)
  • Songkhla
    • Hat Yai, Songkhla, Thailand, 90110
      • Prince of Songkla University Faculty of Medicine ( Site 0005)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control	Other: Pediatric vaccines; Standard of care vaccines administered according to the local recommended schedule.
Experimental: V114; Participants will receive an intramuscular (IM) injection.	Biological: V114; IM injection; Other Names: VAXNEUVANCE™; Pneumococcal 15-Valent Conjugate Vaccine; Other: Pediatric vaccines; Standard of care vaccines administered according to the local recommended schedule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2020
• Primary Completion (Estimated): June 5, 2025
• Study Completion (Estimated): June 5, 2025

Study Registration Dates

• First Submitted: December 9, 2019
• First Submitted That Met QC Criteria: December 9, 2019
• First Posted (Actual): December 10, 2019

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Media; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: V114-032 (Other Identifier: Merck)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No