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Trial record 1 of 1 for:    NCT03571607
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A Safety And Immunogenicity Study Of A 13-valent Pneumococcal Conjugate Vaccine In Japanese Subjects Aged 6 To 64 Years.

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ClinicalTrials.gov Identifier: NCT03571607
Recruitment Status : Completed
First Posted : June 27, 2018
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE June 20, 2018
First Posted Date  ICMJE June 27, 2018
Last Update Posted Date January 25, 2019
Actual Study Start Date  ICMJE July 12, 2018
Actual Primary Completion Date November 16, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2018)
  • Percentage of subjects reporting local reactions within 7days for subjects aged 6 to 17 years or 14 days for subjects aged 18 to 64 years after vaccination (redness, swelling, and pain at injection site). [ Time Frame: Day 1-7 for subjects aged 6 to 17 years or Day 1-14 for subjects aged 18 to 64 years ]
  • Percentage of subjects reporting systemic events within 7days for subjects aged 6 to 17 years or 14 days for subjects aged 18 to 64 years after vaccination (fever, fatigue, headache, vomiting, diarrhea, muscle pain, joint pain). [ Time Frame: Day 1-7 for subjects aged 6 to 17 years or Day 1-14 for subjects aged 18 to 64 years ]
  • Percentage of subjects reporting adverse events (AEs) within 1 month after vaccination. [ Time Frame: 1 month after vaccination ]
  • Percentage of subjects reporting serious adverse events (SAEs) within 1 month after vaccination. [ Time Frame: 1 month after vaccination ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03571607 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2018)
  • Pneumococcal serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) measured 1 month after vaccination. [ Time Frame: 1 month after vaccination ]
  • Pneumococcal serotype-specific OPA geometric mean fold rises (GMFRs) measured from before vaccination to 1 month after vaccination. [ Time Frame: 1 month after vaccination ]
  • Pneumococcal serotype-specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) measured 1 month after vaccination. [ Time Frame: 1 month after vaccination ]
  • Pneumococcal serotype-specific IgG geometric mean fold rises (GMFRs) measured from before vaccination to 1 month after vaccination. [ Time Frame: 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 A Safety And Immunogenicity Study Of A 13-valent Pneumococcal Conjugate Vaccine In Japanese Subjects Aged 6 To 64 Years.
Official Title  ICMJE A PHASE 3, MULTICENTER, SINGLE-ARM, OPEN-LABEL STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A SINGLE DOSE OF 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN JAPANESE SUBJECTS AGED 6 TO 64 YEARS WHO ARE CONSIDERED TO BE AT INCREASED RISK OF PNEUMOCOCCAL DISEASE AND WHO ARE NAIVE TO PNEUMOCOCCAL VACCINES
Brief Summary This study is to evaluate the safety, tolerability and immunogenicity of a single dose of 13-valent pneumococcal conjugate vaccine in Japanese subjects aged 6 to 64 years who are considered to be at increased risk of pneumococcal disease and who are naive to pneumococcal vaccines.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Pneumococcal Infections
Intervention  ICMJE Biological: 13-valent pneumococcal conjugate vaccine
A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.
Other Name: 13vPnC
Study Arms  ICMJE Experimental: 13-valent pneumococcal conjugate vaccine
Intervention: Biological: 13-valent pneumococcal conjugate vaccine
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: January 22, 2019)
206
Original Estimated Enrollment  ICMJE
 (submitted: June 20, 2018)
200
Actual Study Completion Date  ICMJE November 16, 2018
Actual Primary Completion Date November 16, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Japanese males and females aged 6 to <65 years at enrollment.
  • Subjects with an increased risk of pneumococcal disease determined by documented medical history, physical examination, and clinical judgment of the investigator.

Exclusion Criteria:

  • Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt during study participation.
  • End-stage disease including but not limited to metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, or end-stage renal disease with or without dialysis.
  • Graft-versus-host disease (GVHD), history of solid organ transplant within 6 months before investigational product administration or history of HSCT, or potential for solid organ transplant or HSCT during study participation.
  • Receipt of cytotoxic chemotherapy or blood products within 3 months before investigational product administration or anti-B-cell antibodies within 6 months before investigational product administration through completion of study participation.
  • Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components.
  • Documented S pneumoniae infection within the past 5 years before investigational product administration.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 64 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03571607
Other Study ID Numbers  ICMJE B1851172
2018-003054-24 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.
URL: 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 January 2019

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