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

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NCT03313050

Last updated on April 19, 2018
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FOR MORE INFORMATION
Study Location
Achieve Clinical Research LLC
Birmingham, Alabama, 35216 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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

NCT03313050
Pfizer
Recruiting
A Trial To Evaluate A Multivalent Pneumococcal Conjugate Vaccine In Healthy Adults 50-85 Years Of Age

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[email protected]

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

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).
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
Observer-blinded

Primary Purpose: Prevention
Pneumococcal Infections
  • Biological: Multivalent
    Pneumococcal conjugate vaccine
  • Biological: Tdap
    Tetanus, diphtheria, acellular pertussis vaccine
  • Biological: polysaccharide
    23-valent pneumococcal polysaccharide vaccine
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
506
May 28, 2019
May 28, 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years to 85 Years   (Adult, Senior)
Yes

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
United States
 
 
NCT03313050
C3571001
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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