Clinical trial NCT04193215: V114 and Acute Otitis Media (V114-032/PNEU-ERA)
Official title: A Study of V114 and Acute Otitis Media in Children (PNEU-ERA)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Acute Otitis Media (AOM)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2019-12-10
Enrollment: 7000
Sex: ALL
Minimum age (years): 42
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants with a First Episode of Vaccine-Type Acute Otitis Media (VT-AOM) Caused by the Pneumococcal Serotypes Contained in V114
timeFrame: Up to ~36 months
measure: Percentage of Participants with Serious Adverse Events
timeFrame: Up to ~36 months
measure: Percentage of Participants with Vaccine-Related Serious Adverse Events
timeFrame: Up to ~36 months
measure: Percentage of Participants Who Discontinued the Study due to Serious Adverse Events
timeFrame: Up to ~36 months
measure: Percentage of Participants Who Died
timeFrame: Up to ~36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Chulalongkorn University ( Site 0008)
state: Krung Thep Maha Nakhon
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital ( Site 0003)
state: Krung Thep Maha Nakhon
city: Bangkok
country: Thailand
facility: Siriraj Hospital ( Site 0004)
state: Krung Thep Maha Nakhon
city: Rajthevee
country: Thailand
facility: Ramathibodi Hospital, Mahidol University ( Site 0009)
state: Krung Thep Maha Nakhon
city: Sai Mai
country: Thailand
facility: Bhumibol Adulyadej Hospital ( Site 0013)
state: Krung Thep Maha Nakhon
city: Pak Kret
country: Thailand
facility: Panyananthaphikkhu Chonprathan Medical Center ( Site 0014)
state: Nonthaburi
city: Khong Luang
country: Thailand
facility: Faculty of Medicine Thammasat Univ. ( Site 0007)
state: Pathum Thani
city: Hat Yai
country: Thailand
facility: Prince of Songkla University Faculty of Medicine ( Site 0005)
state: Songkhla
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital ( Site 0001)
city: Chiang Rai
country: Thailand
facility: Chiang Rai Prachanuchro Hospital-Pediatrics ( Site 0015)
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital ( Site 0002)
city: Nonthaburi
country: Thailand
facility: Bamrasnaradura Infectious Disease Institute ( Site 0011)
city: Ubon Ratchathani
country: Thailand
facility: Sappasit Prasong Hosptial-Pediatric ( Site 0016)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: