Trial to Evaluate the Safety and Immunogenicity of Multivalent Pneumococcal Vaccines in Japanese Adults 18 to 49 Years of Age

June 11, 2019 updated by: Pfizer

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

This Phase 1b will describe the safety and immunogenicity of 2 multivalent pneumococcal conjugate vaccine formulations in healthy Japanese adults in the United States.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Garden Grove, California, United States, 92845
        • Collaborative Neuroscience Network, LLC.
      • Long Beach, California, United States, 90806
        • Collaborative Neuroscience Network, LLC.
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • East-West Medical Research Institute
    • New Jersey
      • Eatontown, New Jersey, United States, 07724
        • Clinilabs Drug Development Corporation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Prevnar 13
13 valent Pneumococcal Conjugate
Biological: Prevnar 13
13 valent Pneumococcal Conjugate
Experimental: multivalent pneumococcal conjugate formulation 1
Biological: multivalent pneumococcal conjugate formulation 1
multivalent pneumococcal conjugate formulation 1
Experimental: multivalent pneumococcal conjugate formulation 2
Biological: multivalent pneumococcal conjugate formulation 2
multivalent pneumococcal conjugate formulation 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjects reporting prompted local reactions within 14 days after vaccination (redness, swelling, and pain at the injection site).
Time Frame: 14 days after vaccination
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).
Time Frame: 14 days after vaccination
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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 6 months after vaccination
Subjects reporting newly diagnosed chronic medical conditions (NDCMCs) within 6 months after vaccination.
6 months after vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunogenicity
Time Frame: 1 month after vaccination
Pneumococcal serotype-specific OPA titers 1 month after vaccination.
1 month after vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2018

Primary Completion (Actual)

March 29, 2019

Study Completion (Actual)

March 29, 2019

Study Registration Dates

First Submitted

August 20, 2018

First Submitted That Met QC Criteria

August 20, 2018

First Posted (Actual)

August 22, 2018

Study Record Updates

Last Update Posted (Actual)

June 12, 2019

Last Update Submitted That Met QC Criteria

June 11, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B7471005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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