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Study Comparing a 13-valent Pneumococcal Conjugate Vaccine With 23-valent Pneumococcal Polysaccharide Vaccine in Adults

Last updated on December 17, 2017

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Study Location
Pfizer Investigational Site
Huntsville, Alabama, 35802 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
18-64 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- First Cohort: Healthy Male and female adults 60 to 64 years of age at time of
enrollment.

- Second Cohort: Healthy Male and female adults 50 to 59 years of age at time of
enrollment.

- Third Cohort: Healthy Male and female adults 18 to 49 years of age at time of
enrollment.

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

- Previous immunization with any licensed or experimental pneumococcal vaccine.

- Serious chronic disorders 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 which
in the investigator's opinion precludes the subject from participating in the study.

- Known or suspected impairment of immunological function.

NCT00427895
Pfizer
Completed
Study Comparing a 13-valent Pneumococcal Conjugate Vaccine With 23-valent Pneumococcal Polysaccharide Vaccine in Adults

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Study Comparing a 13-valent Pneumococcal Conjugate Vaccine With 23-valent Pneumococcal Polysaccharide Vaccine in Adults
A Phase 3, Randomized, Active-Controlled, Modified Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine (13vPnC) Compared to a 23-valent Pneumococcal Polysaccharide Vaccine (23vPS) in Adults 60 to 64 Years Old Who Are Naive to 23vPS and the Safety, Tolerability, and Immunogenicity of 13vPnC in Adults 18 to 59 Years Old Who Are Naïve to 23vPS
This study will assess the safety, tolerability and immune response of 13-valent pneumococcal conjugate vaccine (13vPnC) compared with 23-valent Pneumococcal Polysaccharide Vaccine (23vPS). Although the study started with only 1 population, amendments to the original protocol will now reflect three participant populations. Three age cohorts will be enrolled. The first cohort (age 60-64) will be blinded. Cohort 2 (age 50-59) and cohort 3 (age 18-49) are open label. Subjects in cohorts 1 and 2 will receive 2 vaccinations 3-4 years apart. Subjects in cohort 3 will receive 1 vaccination. All participants should be naïve of 23vPS. Comparisons of immune responses from the different cohorts will be done.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Pneumococcal Infections
  • Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)
    0.5 mL dose administered on day 1
  • Biological: 23-valent Pneumococcal Polysaccharide Vaccine (23vPS)
    0.5 mL dose administered on day 1
  • Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)
    0.5 mL dose administered 3-4 years after dose 1
  • Biological: 23-valent Pneumococcal Polysaccharide Vaccine (23vPS)
    0.5 mL dose administered 3-4 years after dose 1
  • Experimental: 13vPnC Cohort 1, Vaccination 1
    Participants aged 60-64 years were given a 0.5 mL dose administered on day 1.
    Intervention: Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)
  • Active Comparator: 23vPS Cohort 1, Vaccination 1
    Participants aged 60-64 years were given a 0.5 mL dose administered on day 1.
    Intervention: Biological: 23-valent Pneumococcal Polysaccharide Vaccine (23vPS)
  • Experimental: 13vPnC Cohort 2, Vaccination 1
    Participants aged 50-59 years given a 0.5 mL dose administered on day 1.
    Intervention: Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)
  • Experimental: 13vPnC Cohort 3, Vaccination 1
    Participants aged 18-49 years given a 0.5 mL dose administered on day 1.
    Intervention: Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)
  • Experimental: 13vPnC Cohort 1, Vaccination 2
    Participants aged 60-64 years who received 13vPnC at vaccination 1 receive a 0.5 mL dose of 13vPnC administered 3-4 years after dose 1.
    Intervention: Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)
  • Active Comparator: 23vPS Cohort 1, Vaccination 2
    Participants aged 60-64 years who received 23vPS at vaccination 1 receive a 0.5 mL dose of 23vPS administered 3-4 years after dose 1.
    Intervention: Biological: 23-valent Pneumococcal Polysaccharide Vaccine (23vPS)
  • Experimental: 13vPnC Cohort 2, Vaccination 2
    Participants aged 50-59 years who received 13vPnC at vaccination 1 receive a 0.5 mL dose of 13vPnC administered 3-4 years after dose 1.
    Intervention: Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2141
August 2011
August 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • First Cohort: Healthy Male and female adults 60 to 64 years of age at time of enrollment.
  • Second Cohort: Healthy Male and female adults 50 to 59 years of age at time of enrollment.
  • Third Cohort: Healthy Male and female adults 18 to 49 years of age at time of enrollment.

Exclusion Criteria:

  • Previous immunization with any licensed or experimental pneumococcal vaccine.
  • Serious chronic disorders 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 which in the investigator's opinion precludes the subject from participating in the study.
  • Known or suspected impairment of immunological function.
Sexes Eligible for Study: All
18 Years to 64 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00427895
6115A1-004
B1851019
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2012

ICMJE     Data element required by the

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

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