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Study Evaluating Persistence Of Antibody Response Elicited By 13vPnC In Healthy Adults Previously Vaccinated (AB PERSISTENCE)

Pfizer logo

Pfizer

Status and phase

Completed
Phase 3

Conditions

Healthy

Treatments

Other: Blood draw

Study type

Interventional

Funder types

Industry

Identifiers

NCT01025336
B1851029
6115A1-3018

Details and patient eligibility

About

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).

Enrollment

962 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

962 participants in 2 patient groups

23vPS Naive
Other group
Description:
Group 1.1 13vPnC/13vPnC Group 1.2 13vPnC/23vPS Group 2 23vPS/13vPNC
Treatment:
Other: Blood draw
Other: Blood draw
Prior 23vPS>/= 5 years
Other group
Description:
Group 1 13vPnC/13vPnC Group 2 23vPS/13vPnC
Treatment:
Other: Blood draw
Other: Blood draw

Trial contacts and locations

29

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Data sourced from clinicaltrials.gov

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