Evaluation of the Immunogenicity and Reactogenicity of a Pneumococcal Conjugate Vaccine in Healthy Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

611 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2008-12-31

Brief Summary

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To compare the relative immunogenicity and reactogenicity of the existing 23 valent plain pneumococcal vaccine and a 7 valent pneumococcal conjugate vaccine in healthy UK adults aged 50-80 years, and subsequent antibody persistence and response to boosting.

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Detailed Description

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Conditions

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Streptococcus Pneumoniae

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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pneumococcal conjugate vaccine

Pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Written informed consent for participation in the study; ages between 50 and 80 years at recruitment

Exclusion Criteria

* Lack of adequate comprehension of the information sheet, consent form and study nurse's explanation of the study in order to give informed consent.
* Current participation in any other clinical trial
* Any vaccination in the previous month (except influenza vaccination which can be given at any time during the study)
* Prior pneumococcal conjugate vaccine (PNC)
* 23 valent pneumococcal vaccine(PPV) in last 5 years
* Severe general or local reaction to a previous dose of PNC or PPV
* Patients currently immunocompromised as listed in UK Handbook "Immunisation Against Infectious Disease" ed 1996
* Patients who have received intravenous immunoglobulin in the previous month or who will require replacement intravenous immunoglobulin during the period of the study
* Patients in whom pneumococcal vaccination (PPV) is currently recommended as per the UK Handbook "Immunisation Against Infectious Disease"
* Deferral of vaccination if acute systemic illness or temperature \>38C on day of vaccination

Minimum Eligible Age

50 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes