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Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Elderly Subjects

NCT ID: NCT00500357

Last Updated: 2011-04-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2010-01-31

Brief Summary

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This is a follow-up study to the core study NCT00269672 (6115A1-500). This study will further evaluate the safety, tolerability, and immunogenicity of 13-valent pneumococcal conjugate vaccine (13vPnC) when administered to subjects who have already received one dose of 13vPnC, and one dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) one year later. This study will determine if a subsequent dose of 13vPnC one year later results in similar or greater immune response (body's ability to protect against disease) than that measured after the initial dose of 13vPnC.

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Detailed Description

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Conditions

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Vaccines, Pneumococcal Conjugate Vaccine

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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13-valent Pneumococcal Conjugate Vaccine

1 dose 13vPnC

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Previous participant of study 6115A1-500 and received 13vPnC +AlPO4 / 23vPS
* Generally healthy male or female adults 65 years of age or older
* Available for the duration of the trial - approximately 1 month
* No history of severe adverse reaction associated with a vaccine

* MMSE score less than or equal to 21 was an exclusion criteria.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Wyeth

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Bishop Lavis, , South Africa

Site Status

Bloemfontein, , South Africa

Site Status

Brits, , South Africa

Site Status

Cape Town, , South Africa

Site Status

Cape Town, , South Africa

Site Status

eManzimtoti, , South Africa

Site Status

Lenasia, , South Africa

Site Status

Paarl, , South Africa

Site Status

Parow, , South Africa

Site Status

Parys, , South Africa

Site Status

Pretoria, , South Africa

Site Status

Pretoria, , South Africa

Site Status

Pretoria, , South Africa

Site Status

Pretoria, , South Africa

Site Status

Scottburgh South, , South Africa

Site Status

Vanderbijlpark, , South Africa

Site Status

Countries

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South Africa

References

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Juergens C, de Villiers PJ, Moodley K, Jayawardene D, Jansen KU, Scott DA, Emini EA, Gruber WC, Schmoele-Thoma B. Safety and immunogenicity of 13-valent pneumococcal conjugate vaccine formulations with and without aluminum phosphate and comparison of the formulation of choice with 23-valent pneumococcal polysaccharide vaccine in elderly adults: a randomized open-label trial. Hum Vaccin Immunother. 2014;10(5):1343-53. doi: 10.4161/hv.27998. Epub 2014 Feb 27.

Reference Type DERIVED
PMID: 24576885 (View on PubMed)

Other Identifiers

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6115A1-3009

Identifier Type: -

Identifier Source: org_study_id

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