Concomitant Administration of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) With Influenza Vaccine in 23-valent Pneumococcal Polysaccharide (23vPS) Pre-vaccinated Adults.

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NCT02124161

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Study Location
Achieve Clinical Research, LLC
Birmingham, Alabama, 35216, 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.
PREVENTION OF INVASIVE PNEUMOCOCCAL DISEASE
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject has been informed of all pertinent aspects of the study.

2. Male or female adults 50 years of age or older.

3. Documented vaccination with 1 or more prior doses of 23vPS, the last given at least 1 year prior to study enrollment.

4. Negative urine pregnancy test for all female subjects who are of child bearing potential.

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


1. Previous vaccination with Prevnar®, Prevnar 13®, or any other investigational
pneumococcal conjugate vaccine.


2. History of severe adverse reactions associated with any vaccine or vaccine-related
component.


3. Allergic to egg proteins (egg or egg products) and chicken proteins.


4. History of Guillain-Barré syndrome.


5. Vaccination with any influenza vaccine within 6 months (182 days) before
investigational product administration.


6. Documented S pneumoniae infection within the past 5 years before investigational
product administration.

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PREVENTION OF INVASIVE PNEUMOCOCCAL DISEASEConcomitant Administration of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) With Influenza Vaccine in 23-valent Pneumococcal Polysaccharide (23vPS) Pre-vaccinated Adults.
NCT02124161
  1. Birmingham, Alabama
  2. Huntsville, Alabama
  3. Scottsdale, Arizona
  4. Oakland, California
  5. Sacramento, California
  6. San Francisco, California
  7. Santa Clara, California
  8. DeLand, Florida
  9. Jacksonville, Florida
  10. Jacksonville, Florida
  11. Pinellas Park, Florida
  12. Savannah, Georgia
  13. Mishawaka, Indiana
  14. Council Bluffs, Iowa
  15. Lenexa, Kansas
  16. Metairie, Louisiana
  17. Bellevue, Nebraska
  18. Norfolk, Nebraska
  19. Omaha, Nebraska
  20. Las Vegas, Nevada
  21. Las Vegas, Nevada
  22. Binghamton, New York
  23. Endwell, New York
  24. Rochester, New York
  25. Cary, North Carolina
  26. Greensboro, North Carolina
  27. Hickory, North Carolina
  28. Winston-Salem, North Carolina
  29. Winston-Salem, North Carolina
  30. Columbus, Ohio
  31. Franklin, Ohio
  32. Carnegie, Pennsylvania
  33. Downingtown, Pennsylvania
  34. Warwick, Rhode Island
  35. Mt. Pleasant, South Carolina
  36. Bristol, Tennessee
  37. Knoxville, Tennessee
  38. Austin, Texas
  39. Fort Worth, Texas
  40. San Antonio, Texas
  41. Murray, Utah
  42. Salt Lake City, Utah
  43. Salt Lake City, Utah
  44. South Jordan, Utah
ALL GENDERS
50 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Concomitant Administration of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) With Influenza Vaccine in 23-valent Pneumococcal Polysaccharide (23vPS) Pre-vaccinated Adults.
Official Title  ICMJE A Phase 4, Randomized, Double-blind Trial To Evaluate The Immunogenicity And Safety Of A 13-valent Pneumococcal Conjugate Vaccine When Administered Concomitantly With Seasonal Inactivated Influenza Vaccine In Adults 50 Years And Older Who Received 1 Or More Doses Of 23-valent Pneumococcal Polysaccharide Vaccine Prior To Study Enrollment.
Brief Summary The purpose of this study is to evaluate the immunogenicity and safety of 13-valent pneumococcal polysaccharide vaccine when given concomitantly with seasonal inactivated influenza vaccine to adults 50 years and older who have previously received 23-valent pneumococcal polysaccharide vaccine.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE PREVENTION OF INVASIVE PNEUMOCOCCAL DISEASE
Intervention  ICMJE
  • Biological: 13-valent pneumococcal conjugate vaccine
    One (1) dose (0.5 mL) will be administered intramuscularly into the left deltoid either at Visit 1 or at Visit 2, depending on the randomization group assigned to the subject.
    Other Name: 13vPnC
  • Biological: Seasonal Inactivated Influenza Vaccine
    One (1) dose of SIIV will be administered intramuscularly into the right deltoid of all subjects at Visit 1.
    Other Name: SIIV
  • Other: Placebo
    One (1) dose (0.5 mL) will be administered intramuscularly into the left deltoid either at Visit 1 or at Visit 2, depending on the randomization group assigned to the subject.
Study Arms  ICMJE
  • 13vPnC+SIIV/Placebo
    Interventions:
    • Biological: 13-valent pneumococcal conjugate vaccine
    • Biological: Seasonal Inactivated Influenza Vaccine
    • Other: Placebo
  • Placebo+SIIV/13vPnC
    Interventions:
    • Other: Placebo
    • Biological: Seasonal Inactivated Influenza Vaccine
    • Biological: 13-valent pneumococcal conjugate vaccine
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: April 24, 2014)		882
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject has been informed of all pertinent aspects of the study.
  2. Male or female adults 50 years of age or older.
  3. Documented vaccination with 1 or more prior doses of 23vPS, the last given at least 1 year prior to study enrollment.
  4. Negative urine pregnancy test for all female subjects who are of child bearing potential.

Exclusion Criteria:

  1. Previous vaccination with Prevnar®, Prevnar 13®, or any other investigational pneumococcal conjugate vaccine.
  2. History of severe adverse reactions associated with any vaccine or vaccine-related component.
  3. Allergic to egg proteins (egg or egg products) and chicken proteins.
  4. History of Guillain-Barré syndrome.
  5. Vaccination with any influenza vaccine within 6 months (182 days) before investigational product administration.
  6. Documented S pneumoniae infection within the past 5 years before investigational product administration.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 50 Years and older   (Adult, Older 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 NCT02124161
Other Study ID Numbers  ICMJE B1851138
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 April 2016

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