A single centre randomised clinical trial to assess the antibody response to a 23-valent pneumococcal polysaccharide vaccine administered to adults aged between 50 - 70 years following a 0, 1 or 2 dose priming immunisation with a 7-valent pneumococcal conjugate vaccine

Completed

• Conditions: Infections and Infestations; Bacterial infection of unspecified site; Pneumococcal disease

• Registration Number: ISRCTN78768849
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07-28
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 348

Inclusion Criteria

1. Healthy adults aged 50 - 70 years inclusive
2. In good health as determined by:
2.1. Medical history
2.2. History-directed physical examination
2.3. Clinical judgment of the investigator
3. Able (in the Investigators opinion) and willing to comply with all study requirements including be available for all the visits scheduled in the study
4. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study

Exclusion Criteria

1. Have previously received any pneumococcal vaccine
2. Have received vaccination with a vaccine containing either CRM197 or Diphtheria toxoid within the past 12 months
3. Have a previous ascertained or suspected disease caused C. diphtheriae, or Pneumococcus
4. Have a history of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component
5. Have a known or suspected autoimmune disease or impairment /alteration of immune function resulting from (for example):
5.1. Receipt of any immunosuppressive therapy
5.2. Receipt of immunostimulants
5.3. Congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months or long-term systemic corticosteroid therapy* (*prednisolone or equivalent for more than two consecutive weeks within the past 3 months)
6. Have a suspected or known human immunodeficiency virus (HIV) infection or HIV related disease
7. Have received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 3 months
8. Have a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time
9. Have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
10. Participation in another clinical trial investigating a vaccine, a drug, a medical device, or a medical procedure

Study & Design

• Study Type: Interventional
• Study Design: Not specified