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Trial to Evaluate the Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-naïve Adults

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ClinicalTrials.gov Identifier: NCT03760146
Recruitment Status : Recruiting
First Posted : November 30, 2018
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE November 29, 2018
First Posted Date  ICMJE November 30, 2018
Last Update Posted Date March 26, 2019
Actual Study Start Date  ICMJE December 12, 2018
Estimated Primary Completion Date January 2, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2018)
  • Percentage of subjects reporting prompted local reactions within 10 days after vaccination (redness, swelling, and pain at the injection site). [ Time Frame: Day 10 ]
    Prompted local reactions after Vaccination 1.
  • Percentage of subjects reporting prompted systemic events within 7 days after vaccination (fever, headache, fatigue, muscle pain, and joint pain). [ Time Frame: Day 7 ]
    Prompted systemic events after Vaccination 1.
  • Percentage of subjects reporting adverse events (AEs) within 1 month after vaccination [ Time Frame: 1 month after vaccination ]
    Adverse events occurring within 1 month after vaccination.
  • Percentage of subjects reporting serious adverse events (SAEs) and newly diagnosed chronic medical conditions (NDCMCs) within 6 months after vaccination/Vaccination 1. [ Time Frame: 6 months after vaccination/Vaccination 1 ]
    SAEs and NDCMCs occurring 6 months after vaccine/Vaccination 1.
  • Serotype-specific OPA geometric mean titers (GMTs) in 60 year olds and above 1 month after vaccination. [ Time Frame: 1 month after vaccination ]
    OPA GMTs 1 month after vaccination.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03760146 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2018)
  • Serotype-specific OPA GMTs in 50 through 59 year olds 1 month after vaccination [ Time Frame: 1 month after vaccination ]
    OPA GMTs 1 month after vaccination.
  • Serotype-specific OPA GMTs in 18 through 49 year olds 1 month after vaccination. [ Time Frame: 1 month after vaccination ]
    OPA GMTs 1 month after vaccination.
  • Fold rise in serotype-specific OPA titers from before to 1 month after vaccination. [ Time Frame: From before to 1 month after vaccination ]
    Fold rise in OPA titers 1 month after vaccination.
  • ≥4-Fold rise in serotype-specific OPA titers from before to 1 month after vaccination. [ Time Frame: From before to 1 month after vaccination ]
    Subjects with ≥4-fold rise in OPA titers 1 month after vaccination.
  • Serotype-specific OPA titers greater than or equal to the lower limit of quantitation (LLOQ) 1 month after vaccination. [ Time Frame: 1 month after vaccination ]
    Subjects with OPA titers greater than or equal to LLOQ 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 a 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-naïve Adults
Official Title  ICMJE A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN PNEUMOCOCCAL VACCINE-NAÏVE ADULTS 18 YEARS OF AGE AND OLDER
Brief Summary A Phase 3, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Pneumococcal Disease
Intervention  ICMJE
  • Biological: 20vPnC
    20vPnC
  • Biological: 13vPnC
    Pneumococcal conjugate vaccine
  • Biological: PPSV23
    Pneumococcal polysaccharide vaccine
    Other Name: Pneumovax 23
  • Other: Saline
    Placebo
Study Arms  ICMJE
  • Experimental: 60 years and above 20vPnC/Saline
    20vPnC and saline
    Interventions:
    • Biological: 20vPnC
    • Other: Saline
  • Active Comparator: 60 years and above 13vPnC/PPSV23
    13vPnC and PPSV23
    Interventions:
    • Biological: 13vPnC
    • Biological: PPSV23
  • Experimental: 50 through 59 years of age 20vPnC
    20vPnC
    Intervention: Biological: 20vPnC
  • Experimental: 18 through 49 years of age 20vPnC
    20vPnC
    Intervention: Biological: 20vPnC
  • Active Comparator: 50 through 59 years of age 13vPnC
    13vPnC
    Intervention: Biological: 13vPnC
  • Active Comparator: 18 through 49 years of age 13vPnC
    13vPnC
    Intervention: Biological: 13vPnC
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 29, 2018)
3880
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2, 2020
Estimated Primary Completion Date January 2, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female adults >/= 18 years of age (from the 18th birthday) at enrollment and older.
  2. Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy in the previous 6 weeks or hospitalization for worsening disease within 12 weeks before receipt of investigational product.
  3. Negative urine pregnancy test at Visit1 for all subjects who are of childbearing potential.

Exclusion Criteria:

  1. Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
  2. History of microbiologically proven invasive disease caused by S pneumoniae.
  3. Serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the subject from participating in the study.
  4. Pregnant female subjects or breastfeeding female subjects.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03760146
Other Study ID Numbers  ICMJE B7471007
2018-004279-11 ( EudraCT Number )
Has Data Monitoring Committee Yes
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: 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 March 2019

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