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

Last updated on December 6, 2018

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
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
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

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.

NCT03760146
Pfizer
Not yet recruiting
Trial to Evaluate the Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-naïve Adults

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Trial to Evaluate the Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-naïve Adults
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
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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Pneumococcal Disease
  • Biological: 20vPnC
    20vPnC
  • Biological: 13vPnC
    Pneumococcal conjugate vaccine
  • Biological: PPSV23
    Pneumococcal polysaccharide vaccine
    Other Name: Pneumovax 23
  • Other: Saline
    Placebo
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
3880
Same as current
January 2, 2020
January 2, 2020   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Not Provided
 
 
NCT03760146
B7471007
2018-004279-11 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
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 2018

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

BY EMAIL

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[email protected]



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