Study Evaluating Antibody Response Of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) 24 Months After Toddler Dose.

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NCT01026038

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Study Location
Pfizer Investigational Site
Ancenis, , 44150, France
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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.
13-valent Pneumococcal Vaccine, Immunization, Safety, Antibody Response
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
3 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy subjects at least 3 years of age, who received all 4 assigned doses of pneumococcal conjugate vaccine and completed Study 6096A1-008-EU (NCT00366678) for at least 24 months

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


- Vaccination with any licensed or investigational pneumococcal vaccine since completion
of Study 6096A1-008-EU(NCT00366678).


- History of culture-proven invasive disease caused by S pneumoniae since the completion
of Study 6096A1-008-EU (NCT00366678).


- Previous anaphylactic reaction to any vaccine or vaccine-related component.


- Contraindication to vaccination

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13-valent Pneumococcal Vaccine, Immunization, Safety, Antibody ResponseStudy Evaluating Antibody Response Of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) 24 Months After Toddler Dose.
NCT01026038
  1. Ancenis,
  2. Bondues,
  3. Brest,
  4. Chalons En Champagne,
  5. Draguignan,
  6. Ecully,
  7. Essey Les Nancy,
  8. Floirac,
  9. Garges Les Gonesses,
  10. Joue Les Tours,
  11. Le Havre,
  12. Lingolsheim,
  13. Lyon,
  14. Maromme,
  15. Moutiers,
  16. Nancy,
  17. Nice,
  18. Olonne Sur Mer,
  19. Strasbourg,
  20. Strasbourg,
  21. Talence,
  22. Thionville,
  23. Tours,
  24. Villers Les Nancy,
  25. Vitry Sur Seine,
ALL GENDERS
3 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Antibody Response Of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) 24 Months After Toddler Dose.
Official Title  ICMJE A Phase 3, Open-label Study to Evaluate Persistence of the Antibody Response Elicited by Pneumococcal Conjugate Vaccine in Healthy Children Who Have Been Previously Immunized With a 4-Dose Series of a Pneumococcal Conjugate Vaccine During Infancy in Study 6096A1-008-EU and the Safety and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine Administered at Least 24 Months After the Last Toddler Dose of Pneumococcal Conjugate Vaccine
Brief Summary This is an open-label study (a study in which the doctors and participants know which drug or vaccine is being administered) in children who previously received a 4-dose series of a pneumococcal conjugate vaccine (PnC) during infancy in Study 6096A1-008-EU (NCT00366678). In this study, participants will receive an additional dose of 13-valent pneumococcal conjugate vaccine. The purpose of this study is to evaluate persistence, if any, of the antibody response by measuring any remaining pneumococcal antibodies since the previous study. This study will also evaluate the safety and immunogenicity of 13-valent pneumococcal conjugate vaccine when administered at least 24 months after the last dose of pneumococcal conjugate vaccine.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • 13-valent Pneumococcal Vaccine
  • Immunization
  • Safety
  • Antibody Response
Intervention  ICMJE Biological: 13-valent pneumococcal conjugate vaccine
All subjects will receive 1 dose (0.5 mL), IM of 13vPnC vaccine. (at least 24 months after toddler dose).
Study Arms  ICMJE Experimental: 1
1 dose (0.5 mL), IM of 13vPnC vaccine.
Intervention: 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: January 5, 2012)		263
Original Estimated Enrollment  ICMJE
 (submitted: December 2, 2009)		500
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy subjects at least 3 years of age, who received all 4 assigned doses of pneumococcal conjugate vaccine and completed Study 6096A1-008-EU (NCT00366678) for at least 24 months

Exclusion Criteria:

  • Vaccination with any licensed or investigational pneumococcal vaccine since completion of Study 6096A1-008-EU(NCT00366678).
  • History of culture-proven invasive disease caused by S pneumoniae since the completion of Study 6096A1-008-EU (NCT00366678).
  • Previous anaphylactic reaction to any vaccine or vaccine-related component.
  • Contraindication to vaccination
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 3 Years and older   (Child, 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 France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01026038
Other Study ID Numbers  ICMJE 6096A1-3021
B1851016
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 January 2012

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