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

NCT ID: NCT01025336

Last Updated: 2012-06-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

962 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-10-31

Brief Summary

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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).

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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23vPS Naive

Group 1.1 13vPnC/13vPnC Group 1.2 13vPnC/23vPS Group 2 23vPS/13vPNC

Group Type OTHER

Blood draw

Intervention Type OTHER

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

Prior 23vPS>/= 5 years

Group 1 13vPnC/13vPnC Group 2 23vPS/13vPnC

Group Type OTHER

Blood draw

Intervention Type OTHER

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

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Chandler, Arizona, United States

Site Status

Pfizer Investigational Site

Phoenix, Arizona, United States

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Denver, Colorado, United States

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Pinellas Park, Florida, United States

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Meridian, Idaho, United States

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Wichita, Kansas, United States

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Lexington, Kentucky, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Rochester, New York, United States

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Cary, North Carolina, United States

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Durham, North Carolina, United States

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Raleigh, North Carolina, United States

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Raleigh, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Corvallis, Oregon, United States

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Eugene, Oregon, United States

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Carnegie, Pennsylvania, United States

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Grove City, Pennsylvania, United States

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Jefferson, Pennsylvania, United States

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Penndel, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Greer, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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Bristol, Tennessee, United States

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Nashville, Tennessee, United States

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Pfizer Investigational Site

Austin, Texas, United States

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Pfizer Investigational Site

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Schmoele-Thoma B, van Cleeff M, Greenberg RN, Gurtman A, Jones TR, Sundaraiyer V, Gruber WC, Scott DA. Persistence of antibodies 1 year after sequential administration of the 13-valent pneumococcal conjugate vaccine and the 23-valent pneumococcal polysaccharide vaccine in adults. Hum Vaccin Immunother. 2019;15(3):575-583. doi: 10.1080/21645515.2018.1538618. Epub 2019 Jan 16.

Reference Type DERIVED
PMID: 30648932 (View on PubMed)

Related Links

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Other Identifiers

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B1851029

Identifier Type: -

Identifier Source: secondary_id

6115A1-3018

Identifier Type: -

Identifier Source: org_study_id

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