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OpenTrials
Completed

NCT Number: NCT00197821

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

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.

Completed

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Key information

Conditions

Streptococcus Pneumoniae

Age range

50 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pneumococcal conjugate vaccine

Biological

Pneumococcal conjugate vaccine

Primary outcomes

  1. Immunogenicity

    Time frame: Completed by dec 2008

    ELISA based asssay for serotype specific pneumococcal responses

Sponsors and collaborators

Lead sponsor

Public Health England

Other Gov

Registry information

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Sep 20, 2005
Registry last updated
Mar 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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