Trial to Evaluate the Safety and Immunogenicity of Multivalent Pneumococcal Vaccines in Japanese Adults 18 to 49 Years of Age
A PHASE 1B, RANDOMIZED, CONTROLLED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINES IN HEALTHY JAPANESE ADULTS 18 TO 49 YEARS OF AGE
1 other identifier
interventional
104
1 country
4
Brief Summary
This Phase 1b will describe the safety and immunogenicity of 2 multivalent pneumococcal conjugate vaccine formulations in healthy Japanese adults in the United States.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2018
Shorter than P25 for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2018
CompletedFirst Posted
Study publicly available on registry
August 22, 2018
CompletedStudy Start
First participant enrolled
August 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 29, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 29, 2019
CompletedJune 12, 2019
June 1, 2019
7 months
August 20, 2018
June 11, 2019
Conditions
Outcome Measures
Primary Outcomes (5)
Subjects reporting prompted local reactions within 14 days after vaccination (redness, swelling, and pain at the injection site).
Subjects reporting prompted local reactions within 14 days after vaccination (redness, swelling, and pain at the injection site).
14 days after vaccination
Subjects reporting prompted systemic events within 14 days after vaccination (fever, headache, fatigue, muscle pain, and joint pain).
Subjects reporting prompted systemic events within 14 days after vaccination (fever, headache, fatigue, muscle pain, and joint pain).
14 days after vaccination
Subjects reporting adverse events (AEs) within 1 month after vaccination.
Subjects reporting adverse events (AEs) within 1 month after vaccination.
1 month after vaccination
Subjects reporting serious adverse events (SAEs) within 6 months after vaccination.
Subjects reporting serious adverse events (SAEs) within 6 months after vaccination.
6 months after vaccination
Subjects reporting newly diagnosed chronic medical conditions (NDCMCs) within 6 months after vaccination.
Subjects reporting newly diagnosed chronic medical conditions (NDCMCs) within 6 months after vaccination.
6 months after vaccination
Secondary Outcomes (1)
Immunogenicity
1 month after vaccination
Study Arms (3)
Prevnar 13
ACTIVE COMPARATOR13 valent Pneumococcal Conjugate
multivalent pneumococcal conjugate formulation 1
EXPERIMENTALmultivalent pneumococcal conjugate formulation 1
multivalent pneumococcal conjugate formulation 2
EXPERIMENTALmultivalent pneumococcal conjugate formulation 2
Interventions
multivalent pneumococcal conjugate formulation 1
multivalent pneumococcal conjugate formulation 2
Eligibility Criteria
You may qualify if:
- Male or female Japanese subjects 18 to 49 years of age, defined as Japanese born in Japan, with both parents and 4 grandparents who wer born in Japan (family tree by history), and who have not lived outside of Japan for more than 5 years total (confirmed by passport or interview)
You may not qualify if:
- Participation in other studies involving investigational drug(s), investigational vaccines, or investigational medical devised within 28 days prior to study entry and/or during study participation. Participation in purely observational studies is acceptable.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (4)
Collaborative Neuroscience Network, LLC.
Garden Grove, California, 92845, United States
Collaborative Neuroscience Network, LLC.
Long Beach, California, 90806, United States
East-West Medical Research Institute
Honolulu, Hawaii, 96814, United States
Clinilabs Drug Development Corporation
Eatontown, New Jersey, 07724, United States
Related Publications (1)
Fitz-Patrick D, Young M Jr, Scott DA, Scully IL, Baugher G, Peng Y, Jansen KU, Gruber W, Watson W. A randomized phase 1 study of the safety and immunogenicity of 2 novel pneumococcal conjugate vaccines in healthy Japanese adults in the United States. Hum Vaccin Immunother. 2021 Jul 3;17(7):2249-2256. doi: 10.1080/21645515.2020.1863177. Epub 2021 Feb 5.
PMID: 33545022DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2018
First Posted
August 22, 2018
Study Start
August 29, 2018
Primary Completion
March 29, 2019
Study Completion
March 29, 2019
Last Updated
June 12, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.