Status:
COMPLETED
Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-033)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Pneumococcal Infections
Eligibility:
All Genders
2-6 years
Phase:
PHASE3
Brief Summary
The purpose of this clinical study is to evaluate the safety and immunogenicity of a 4-dose schedule (3-dose primary series followed by a toddler dose) of V114 compared with Pneumococcal 13-valent Con...
Eligibility Criteria
Inclusion
- \- Japanese male or female
Exclusion
- Has a history of invasive pneumococcal disease (IPD)
- Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV), or any diphtheria toxoid containing vaccine
- Has a known or suspected impairment of immunological function
- Has a history of congenital or acquired immunodeficiency
- Has or his/her mother has a documented human immunodeficiency virus (HIV) infection
- Has or his/her mother has a documented hepatitis B surface antigen-positive test
- Has known or history of functional or anatomic asplenia
- Has a history of autoimmune disease
- Has a known neurologic or cognitive behavioral disorder
- Has received a dose of any pneumococcal vaccine prior to study entry
- Has received a blood transfusion or blood products, including immunoglobulins
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
694 Patients enrolled
Trial Details
Trial ID
NCT04384107
Start Date
July 1 2020
End Date
December 1 2021
Last Update
July 28 2023
Active Locations (45)
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1
Morinaga Maternity Clinic ( Site 3345)
Kasugai, Aichi-ken, Japan, 486-0836
2
Social Medical Corporation Koujunkai Daido Clinic ( Site 3326)
Nagoya, Aichi-ken, Japan, 457-8511
3
Kyoritsu Narashinodai Hospital ( Site 3332)
Funabashi, Chiba, Japan, 274-0063
4
Sotobo Children's Clinic ( Site 3323)
Isumi, Chiba, Japan, 299-4503