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

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NCT00427895

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Study Location
Pfizer Investigational Site
Huntsville, Alabama, 35802, United States
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Contact
1-800-718-1021
[email protected]
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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
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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Comparing a 13-valent Pneumococcal Conjugate Vaccine With 23-valent Pneumococcal Polysaccharide Vaccine in Adults
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Pneumococcal Infections
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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)
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: August 1, 2012)		2141
Original Enrollment  ICMJE
 (submitted: January 26, 2007)		740
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 64 Years   (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 NCT00427895
Other Study ID Numbers  ICMJE 6115A1-004
B1851019
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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 August 2012

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