Back to resultsTrial to Evaluate the Safety and Immunogenicity of Multivalent Pneumococcal Vaccines in Japanese Adults 18 to 49 Years of Age
Primary Purpose
Pneumococcal Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Prevnar 13
multivalent pneumococcal conjugate formulation 1
multivalent pneumococcal conjugate formulation 2
Sponsored by
About this trial
This is an interventional prevention trial for Pneumococcal Infections
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
Sites / Locations
- Collaborative Neuroscience Network, LLC.
- Collaborative Neuroscience Network, LLC.
- East-West Medical Research Institute
- Clinilabs Drug Development Corporation
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Prevnar 13
multivalent pneumococcal conjugate formulation 1
multivalent pneumococcal conjugate formulation 2
Arm Description
13 valent Pneumococcal Conjugate
multivalent pneumococcal conjugate formulation 1
multivalent pneumococcal conjugate formulation 2
Outcomes
Primary Outcome Measures
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).
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).
Subjects reporting adverse events (AEs) within 1 month after vaccination.
Subjects reporting adverse events (AEs) within 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.
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.
Secondary Outcome Measures
Immunogenicity
Pneumococcal serotype-specific OPA titers 1 month after vaccination.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03642847
Brief Title
Trial to Evaluate the Safety and Immunogenicity of Multivalent Pneumococcal Vaccines in Japanese Adults 18 to 49 Years of Age
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
August 29, 2018 (Actual)
Primary Completion Date
March 29, 2019 (Actual)
Study Completion Date
March 29, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Infections
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prevnar 13
Arm Type
Active Comparator
Arm Description
13 valent Pneumococcal Conjugate
Arm Title
multivalent pneumococcal conjugate formulation 1
Arm Type
Experimental
Arm Description
multivalent pneumococcal conjugate formulation 1
Arm Title
multivalent pneumococcal conjugate formulation 2
Arm Type
Experimental
Arm Description
multivalent pneumococcal conjugate formulation 2
Intervention Type
Biological
Intervention Name(s)
Prevnar 13
Intervention Description
13 valent Pneumococcal Conjugate
Intervention Type
Biological
Intervention Name(s)
multivalent pneumococcal conjugate formulation 1
Intervention Description
multivalent pneumococcal conjugate formulation 1
Intervention Type
Biological
Intervention Name(s)
multivalent pneumococcal conjugate formulation 2
Intervention Description
multivalent pneumococcal conjugate formulation 2
Primary Outcome Measure Information:
Title
Subjects reporting prompted local reactions within 14 days after vaccination (redness, swelling, and pain at the injection site).
Description
Subjects reporting prompted local reactions within 14 days after vaccination (redness, swelling, and pain at the injection site).
Time Frame
14 days after vaccination
Title
Subjects reporting prompted systemic events within 14 days after vaccination (fever, headache, fatigue, muscle pain, and joint pain).
Description
Subjects reporting prompted systemic events within 14 days after vaccination (fever, headache, fatigue, muscle pain, and joint pain).
Time Frame
14 days after vaccination
Title
Subjects reporting adverse events (AEs) within 1 month after vaccination.
Description
Subjects reporting adverse events (AEs) within 1 month after vaccination.
Time Frame
1 month after vaccination
Title
Subjects reporting serious adverse events (SAEs) within 6 months after vaccination.
Description
Subjects reporting serious adverse events (SAEs) within 6 months after vaccination.
Time Frame
6 months after vaccination
Title
Subjects reporting newly diagnosed chronic medical conditions (NDCMCs) within 6 months after vaccination.
Description
Subjects reporting newly diagnosed chronic medical conditions (NDCMCs) within 6 months after vaccination.
Time Frame
6 months after vaccination
Secondary Outcome Measure Information:
Title
Immunogenicity
Description
Pneumococcal serotype-specific OPA titers 1 month after vaccination.
Time Frame
1 month after vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Collaborative Neuroscience Network, LLC.
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Collaborative Neuroscience Network, LLC.
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
East-West Medical Research Institute
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Clinilabs Drug Development Corporation
City
Eatontown
State/Province
New Jersey
ZIP/Postal Code
07724
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
33545022
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7471005&StudyName=A+PHASE+1B%2C+RANDOMIZED%2C+CONTROLLED%2C+DOUBLE-BLIND+TRIAL+TO+EVALUATE+THE+SAFETY+AND+IMMUNOGENICITY+OF+MULTIVALENT+PNEUMOCOCCAL+CONJUGATE+VACCINES+IN+HEALTHY+JAPANESE+ADULTS+18+TO+49+YEARS+OF+AGE
Description
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Trial to Evaluate the Safety and Immunogenicity of Multivalent Pneumococcal Vaccines in Japanese Adults 18 to 49 Years of Age
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