Study Results
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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COMPLETED
PHASE3
7119 participants
INTERVENTIONAL
2020-09-12
2025-12-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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V114
Participants will receive an intramuscular (IM) injection.
V114
IM injection
Pediatric vaccines
Standard of care vaccines administered according to the local recommended schedule.
Control
Pediatric vaccines
Standard of care vaccines administered according to the local recommended schedule.
Interventions
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V114
IM injection
Pediatric vaccines
Standard of care vaccines administered according to the local recommended schedule.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Is male or female, approximately 2 months of age, from 42 days to 90 days of age
Exclusion Criteria
* 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.
42 Days
90 Days
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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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
Phramongkutklao Hospital ( Site 0003)
Bangkok, Bangkok, Thailand
Siriraj Hospital ( Site 0004)
Bangkok, Bangkok, Thailand
Ramathibodi Hospital, Mahidol University ( Site 0009)
Rajthevee, Bangkok, Thailand
Bhumibol Adulyadej Hospital ( Site 0013)
Sai Mai, Bangkok, Thailand
Panyananthaphikkhu Chonprathan Medical Center ( Site 0014)
Pak Kret, Changwat Nonthaburi, Thailand
Faculty of Medicine Thammasat Univ. ( Site 0007)
Khong Luang, Changwat Pathum Thani, Thailand
Prince of Songkla University Faculty of Medicine ( Site 0005)
Hat Yai, Changwat Songkhla, 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
Bamrasnaradura Infectious Disease Institute ( Site 0011)
Nonthaburi, , Thailand
Sappasit Prasong Hosptial-Pediatric ( Site 0016)
Ubon Ratchathani, , Thailand
Countries
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Related Links
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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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