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Study Evaluating Persistence Of Antibody Response Elicited By 13vPnC In Healthy Adults Previously Vaccinated

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Chandler, Arizona, 85224 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
60+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Only study volunteers who received both assigned vaccinations at visit 1 and visit 4
when they participated in either study 6115A1-3010 (NCT00574548) or 6115A1-3005
(NCT00546572)

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

- Vaccination with any licensed or experimental pneumococcal vaccine since being
enrolled in the 6115A1-3005 (NCT00546572) or 6115A1-3010 (NCT00574548) study (other
than study vaccines permitted in 6115A1-3010 or 6115A1-3005)

NCT01025336
Pfizer
Completed
Study Evaluating Persistence Of Antibody Response Elicited By 13vPnC In Healthy Adults Previously Vaccinated

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Study Evaluating Persistence Of Antibody Response Elicited By 13vPnC In Healthy Adults Previously Vaccinated
A Study To Evaluate The Persistence Of The Antibody Response Elicited By 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) In Healthy Adults Who Have Previously Been Vaccinated With Either 2 Doses Of 13vPnC Or 13vPnC And 23-Valent Pneumococcal Polysaccharide Vaccine In Different Sequential Order In Study 6115A1-3010 Or 6115A1 3005
The purpose of this study is to evaluate the levels of antibodies 1 year after receiving the second vaccine dose in two groups of adults over the age of 60: (1) those who have previously received 2 doses of 13-valent pneumococcal conjugate vaccine (13vPnC) and (2) those who have previously received 1 dose of 13vPnc and 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS). This study will also assess whether the use of the 2 vaccines, 13vPnC and 23vPS, administered in different sequential order results in different prolonged antibody levels. This study is limited to individuals who participated in either study 6115A1-3010 (NCT00574548) or 6115A1-3005 (NCT00546572).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Healthy
  • Other: Blood draw
    Group 1.1- 0.5 mL dose of 13vPnC was administered in the deltoid muscle at year 0 and 0.5 mL dose of 13vPnC was administered in the deltoid muscle at year 1 Group 1.2- 0.5 mL dose of 13vPnC was administered in the deltoid muscle at year 0 and 0.5 mL dose of 23vPS was administered in the deltoid muscle at year 1 Group 2- 0.5 mL dose of 23vPS was administered in the deltoid muscle at year 0 and 0.5 mL dose of 13vPnC was administered in the deltoid muscle at year 1
  • Other: Blood draw
    Group 1- 0.5 mL dose of 13vPnC was administered in the deltoid muscle at year 0 and year 1 Group 2- 0.5 mL dose of 23vPS was administered in the deltoid muscle at year 0 and 0.5 mL dose of 13vPNC was administered in the deltoid muscle at year 1
  • 23vPS Naive
    Group 1.1 13vPnC/13vPnC Group 1.2 13vPnC/23vPS Group 2 23vPS/13vPNC
    Intervention: Other: Blood draw
  • Prior 23vPS>/= 5 years
    Group 1 13vPnC/13vPnC Group 2 23vPS/13vPnC
    Intervention: Other: Blood draw
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
962
October 2010
October 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Only study volunteers who received both assigned vaccinations at visit 1 and visit 4 when they participated in either study 6115A1-3010 (NCT00574548) or 6115A1-3005 (NCT00546572)

Exclusion Criteria:

  • Vaccination with any licensed or experimental pneumococcal vaccine since being enrolled in the 6115A1-3005 (NCT00546572) or 6115A1-3010 (NCT00574548) study (other than study vaccines permitted in 6115A1-3010 or 6115A1-3005)
Sexes Eligible for Study: All
60 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01025336
6115A1-3018
B1851029
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2012

ICMJE     Data element required by the

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

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