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

Public Health England

Status and phase

Completed

Phase 2

Conditions

Streptococcus Pneumoniae

Treatments

Biological: pneumococcal conjugate vaccine

Study type

Interventional

Funder types

Other

Identifiers

NCT00197821

PNCA

Details and patient eligibility

About

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.

Enrollment

611 patients

Sex

All

Ages

50 to 79 years old

Volunteers

Accepts Healthy Volunteers

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