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Trial record 1 of 1 for:    NCT03642847
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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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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

Tracking Information
First Submitted Date  ICMJE August 20, 2018
First Posted Date  ICMJE August 22, 2018
Last Update Posted Date June 12, 2019
Actual Study Start Date  ICMJE August 29, 2018
Actual Primary Completion Date March 29, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2018)
  • 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).
  • 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).
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03642847 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2018)
Immunogenicity [ Time Frame: 1 month after vaccination ]
Pneumococcal serotype-specific OPA titers 1 month after vaccination.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial to Evaluate the Safety and Immunogenicity of Multivalent Pneumococcal Vaccines in Japanese Adults 18 to 49 Years of Age
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Pneumococcal Infections
Intervention  ICMJE
  • Biological: Prevnar 13
    13 valent Pneumococcal Conjugate
  • Biological: multivalent pneumococcal conjugate formulation 1
    multivalent pneumococcal conjugate formulation 1
  • Biological: multivalent pneumococcal conjugate formulation 2
    multivalent pneumococcal conjugate formulation 2
Study Arms  ICMJE
  • Active Comparator: Prevnar 13
    13 valent Pneumococcal Conjugate
    Intervention: Biological: Prevnar 13
  • Experimental: multivalent pneumococcal conjugate formulation 1
    multivalent pneumococcal conjugate formulation 1
    Intervention: Biological: multivalent pneumococcal conjugate formulation 1
  • Experimental: multivalent pneumococcal conjugate formulation 2
    multivalent pneumococcal conjugate formulation 2
    Intervention: Biological: multivalent pneumococcal conjugate formulation 2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 23, 2019)
104
Original Estimated Enrollment  ICMJE
 (submitted: August 20, 2018)
99
Actual Study Completion Date  ICMJE March 29, 2019
Actual Primary Completion Date March 29, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03642847
Other Study ID Numbers  ICMJE B7471005
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP