Safety and Immunogenicity of 20vPnC Coadministered With SIIV in Adults ≥65 Years of Age

NCT04526574

Last updated date
Study Location
Lakes Research
Miami Lakes, Florida, 33014, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
65 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female participants ≥65 years of age at the time of consent

- Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease

- Adults who have no history of ever receiving a pneumococcal vaccine, or have a history of receiving a licensed pneumococcal vaccination ≥6 months prior to first study vaccination.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- History of severe adverse reaction associated with a vaccine and/or severe allergic
reaction (eg, anaphylaxis)


- Previous vaccination with any investigational pneumococcal vaccine, or planned receipt
of any licensed or investigational pneumococcal vaccine through study participation.


- Vaccination with any influenza or pneumococcal vaccine <6 months before
investigational product administration, or planned receipt of any licensed or
investigational non-study influenza vaccine during study participation.


-- Serious chronic disorder, that in the investigator's opinion would make the
participant inappropriate for entry into the study


- Other acute or chronic medical or psychiatric condition or laboratory abnormality that
may increase the risk associated with study participation or investigational product
administration or may interfere with the interpretation of study results

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Advanced Information
Descriptive Information
Brief Title  ICMJE Safety and Immunogenicity of 20vPnC Coadministered With SIIV in Adults ?65 Years of Age
Official Title  ICMJE A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE (20VPNC) WHEN COADMINISTERED WITH SEASONAL INACTIVATED INFLUENZA VACCINE (SIIV) IN ADULTS ?65 YEARS OF AGE
Brief Summary Study of the safety and immunogenicity of 20vPnC and influenza vaccine administered at the same visit or separately
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Pneumococcal Disease
Intervention  ICMJE
  • Biological: Experimental 20-valent pneumococcal conjugate vaccine (20vPnC)
    Experimental 20-valent pneumococcal conjugate vaccine (20vPnC)
  • Other: Saline
    Normal saline for injection
  • Biological: Influenza vaccine
    Seasonal inactivated influenza vaccine (SIIV)
Study Arms  ICMJE
  • Active Comparator: Coadministration Group
    Participants receive injections of pneumococcal vaccine (20vPnC) and influenza vaccine at the same visit, and then receive an injection of saline 1 month later.
    Interventions:
    • Biological: Experimental 20-valent pneumococcal conjugate vaccine (20vPnC)
    • Other: Saline
    • Biological: Influenza vaccine
  • Active Comparator: Separate Administration Group
    Participants receive injections of saline and influenza vaccine at the same visit, and then receive an injection of 20vPnC 1 month later.
    Interventions:
    • Biological: Experimental 20-valent pneumococcal conjugate vaccine (20vPnC)
    • Other: Saline
    • Biological: Influenza 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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 9, 2020)
1797
Original Estimated Enrollment  ICMJE
 (submitted: August 21, 2020)
1780
Estimated Study Completion Date  ICMJE June 23, 2021
Estimated Primary Completion Date June 23, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female participants ?65 years of age at the time of consent
  • Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease
  • Adults who have no history of ever receiving a pneumococcal vaccine, or have a history of receiving a licensed pneumococcal vaccination ?6 months prior to first study vaccination.

Exclusion Criteria:

  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis)
  • Previous vaccination with any investigational pneumococcal vaccine, or planned receipt of any licensed or investigational pneumococcal vaccine through study participation.
  • Vaccination with any influenza or pneumococcal vaccine <6 months before investigational product administration, or planned receipt of any licensed or investigational non-study influenza vaccine during study participation.

    -- Serious chronic disorder, that in the investigator's opinion would make the participant inappropriate for entry into the study

  • Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 65 Years and older   (Older 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 NCT04526574
Other Study ID Numbers  ICMJE B7471004
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/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2020

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