Pneumococcal disease Infections and Infestations Bacterial infection of unspecified site
Conditions
Interventions
Interventions used are the Heptavalent pneumococcal conjugate vaccine (Prevenar ®, Wyeth Vaccines) and 23-valent pneumococcal polysaccharide vaccine (Pneumovax® II, Sanofi Pasteur MSD). Participants w
Sponsors
University of Oxford (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute antibody concentration to Pn23 after a one or 2 dose priming immunisation with Pnc7. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Characterisation and measurement of the B cell responses and assessment of memory induction following the three different immunisation regimes 2. Number and nature of any adverse events occurring during the study | — |
Countries
United Kingdom
Outcome results
None listed