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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03642847
Recruitment Status : Completed
First Posted : August 22, 2018
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pneumococcal Infections Biological: Prevnar 13 Biological: multivalent pneumococcal conjugate formulation 1 Biological: multivalent pneumococcal conjugate formulation 2 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : August 29, 2018
Actual Primary Completion Date : March 29, 2019
Actual Study Completion Date : March 29, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Prevnar 13
13 valent Pneumococcal Conjugate
 Biological: Prevnar 13
13 valent Pneumococcal Conjugate
Experimental: multivalent pneumococcal conjugate formulation 1
multivalent pneumococcal conjugate formulation 1
 Biological: multivalent pneumococcal conjugate formulation 1
multivalent pneumococcal conjugate formulation 1
Experimental: multivalent pneumococcal conjugate formulation 2
multivalent pneumococcal conjugate formulation 2
 Biological: multivalent pneumococcal conjugate formulation 2
multivalent pneumococcal conjugate formulation 2


Outcome Measures
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Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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.

  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. Immunogenicity [ Time Frame: 1 month after vaccination ]
    Pneumococcal serotype-specific OPA titers 1 month after vaccination.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03642847


Locations
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United States, California
Collaborative Neuroscience Network, LLC.
Garden Grove, California, United States, 92845
Collaborative Neuroscience Network, LLC.
Long Beach, California, United States, 90806
United States, Hawaii
East-West Medical Research Institute
Honolulu, Hawaii, United States, 96814
United States, New Jersey
Clinilabs Drug Development Corporation
Eatontown, New Jersey, United States, 07724
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03642847    
Other Study ID Numbers: B7471005
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
 Infections
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs