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

Streptococcus Pneumoniae Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00197821
• Other study ID #: PNCA
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: March 27, 2012
• Start date: January 2004
• Est. completion date: December 2008

Study information

• Verified date: March 2012
• Source: Public Health England
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 611
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia
• Streptococcus Pneumoniae

Intervention

Biological:
• pneumococcal conjugate vaccine
Pneumococcal conjugate vaccine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Public Health England

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity	ELISA based asssay for serotype specific pneumococcal responses	Completed by dec 2008

External Links

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