A Trial To Evaluate A Multivalent Pneumococcal Conjugate Vaccine In Healthy Adults 50-85 Years Of Age

NCT03313050

Last updated date
Study Location
Achieve Clinical Research LLC
Birmingham, Alabama, 35216, 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 Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50-85 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Stage 1: Healthy male or female adults 50 to 64 years of age with no history of pneumococcal vaccination

- Stage 2: Healthy male or female adults 65 to 85 years of age previously vaccinated with Prevnar 13 >= 2 months prior to investigational product administration

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


- Stage 1: Vaccination within 12 months before investigational product administration
with diphtheria-, pertussis-, or tetanus-containing vaccine


- Stage 2: Previous vaccination with any pneumococcal vaccine other than a single prior
dose of Prevnar 13

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Trial To Evaluate A Multivalent Pneumococcal Conjugate Vaccine In Healthy Adults 50-85 Years Of Age
Official Title  ICMJE A PHASE 1/2, RANDOMIZED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY ADULTS 50 THROUGH 85 YEARS OF AGE
Brief Summary

This is a 2-stage, phase 1/2, randomized, active-controlled, observer-blinded study with a 2-arm parallel design in each stage.

In Stage 1 healthy adults 50 to 64 years of age with no history of pneumococcal vaccination will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or a licensed tetanus, diphtheria, acellular pertussis combination vaccine (Tdap) (control group).

In Stage 2 healthy adults 65 to 85 years of age previously vaccinated with Prevnar 13 >=2 months prior to investigational product administration will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or the licensed 23-valent pneumococcal polysaccharide vaccine (control group).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
Observer-blinded
Primary Purpose: Prevention
Condition  ICMJE Pneumococcal Infections
Intervention  ICMJE
  • Biological: Multivalent
    Pneumococcal conjugate vaccine
  • Biological: Tdap
    Tetanus, diphtheria, acellular pertussis vaccine
  • Biological: polysaccharide
    23-valent pneumococcal polysaccharide vaccine
Study Arms  ICMJE
  • Experimental: Stage 1 multivalent (ages 50-64 years)
    multivalent
    Intervention: Biological: Multivalent
  • Active Comparator: Stage 1 Tdap (ages 50-64 years)
    Tdap
    Intervention: Biological: Tdap
  • Experimental: Stage 2 multivalent (ages 65-85 years)
    multivalent
    Intervention: Biological: Multivalent
  • Active Comparator: Stage 2 polysaccharide (ages 65-85 years)
    polysaccharide
    Intervention: Biological: polysaccharide
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: October 8, 2018)
511
Original Estimated Enrollment  ICMJE
 (submitted: October 16, 2017)
506
Actual Study Completion Date  ICMJE May 24, 2019
Actual Primary Completion Date May 24, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Stage 1: Healthy male or female adults 50 to 64 years of age with no history of pneumococcal vaccination
  • Stage 2: Healthy male or female adults 65 to 85 years of age previously vaccinated with Prevnar 13 >= 2 months prior to investigational product administration

Exclusion Criteria:

  • Stage 1: Vaccination within 12 months before investigational product administration with diphtheria-, pertussis-, or tetanus-containing vaccine
  • Stage 2: Previous vaccination with any pneumococcal vaccine other than a single prior dose of Prevnar 13
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 50 Years to 85 Years   (Adult, 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 NCT03313050
Other Study ID Numbers  ICMJE C3571001
Has Data Monitoring Committee No
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 May 2020

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