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Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Adults 60 Through 64 Years of Age

Last updated on August 21, 2018

FOR MORE INFORMATION
Study Location
Anaheim Clinical Trials, LLC
Anaheim, California, 92801 United States
Contact
1-800-718-1021
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
60-64 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Male or female adults >/= 60 to =64 years of age (from the 60th birthday up to, but
not including, the 65th birthday) at enrollment.

2. Healthy adults, including adults with preexisting stable disease, defined as disease
not requiring significant change in therapy or requiring hospitalization within 3
months before receipt of investigational product, as determined by medical history,
physical examination, laboratory screening, and clinical judgment of the investigator.

3. Female subjects who are not 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.

NCT03313037
Pfizer
Active, not recruiting
Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Adults 60 Through 64 Years of Age

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Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Adults 60 Through 64 Years of Age
A Phase 2, Randomized, Double-blind Trial To Evaluate The Safety And Immunogenicity Of A Multivalent Pneumococcal Conjugate Vaccine In Adults 60 Through 64 Years Of Age
This is a Phase 2, randomized, double-blinded study with a 2-arm parallel design. Healthy adults aged 60 through 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 followed 1 month later with a dose of saline or Prevnar 13 followed 1 month later with a dose of PPSV23 (control group).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Pneumococcal Infections
  • Biological: Multivalent
    Pneumococcal conjugate vaccine
  • Biological: Prevnar 13
    Pneumococcal conjugate vaccine
  • Biological: PPSV23
    Pneumococcal polysaccharide vaccine
    Other Name: Pneumovax 23
  • Other: Saline
    Placebo
  • Experimental: Multivalent
    Pneumococcal conjugate vaccine
    Interventions:
    • Biological: Multivalent
    • Other: Saline
  • Active Comparator: Control
    Prevnar 13 and PPSV23
    Interventions:
    • Biological: Prevnar 13
    • Biological: PPSV23
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
440
December 21, 2018
December 21, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male or female adults >/= 60 to
  2. Healthy adults, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy or requiring hospitalization within 3 months before receipt of investigational product, as determined by medical history, physical examination, laboratory screening, and clinical judgment of the investigator.
  3. Female subjects who are not 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.
Sexes Eligible for Study: All
60 Years to 64 Years   (Adult)
Yes

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
United States
 
 
NCT03313037
B7471002
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...
URL: http://
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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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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