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| [ Print-friendly version ] |
| 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 |
| ISRCTN | ISRCTN78768849 |
| DOI | 10.1186/ISRCTN78768849 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | 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 |
| Scientific title | |
| Acronym | Protecting adults against pneumococcal disease |
| Serial number at source | 6097A1-800 |
| Study hypothesis | To assess the antibody response (absolute antibody concentration) to a 23-valent pneumococcal polysaccharide vaccine (Pn23) after a 0, 1 or 2 dose priming immunisation with heptavalent pneumococcal conjugate vaccine (Pnc7). |
| Lay summary | Not provided at time of registration |
| Ethics approval | Ethics approval received from the Oxfordshire A Local Research Ethics Committee (LREC) on the 14th September 2006 (ref: 06/Q1604/121). |
| Study design | Randomised clinical trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Pneumococcal disease |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/09/2006 |
| Anticipated end date | 31/08/2008 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 348 |
| Interventions |
Interventions used are the Heptavalent pneumococcal conjugate vaccine (Prevenar ®, Wyeth Vaccines) and 23-valent pneumococcal polysaccharide vaccine (Pneumovax® II, Sanofi Pasteur MSD). Participants will be randomised to receive either:
1. Two doses of the 7-serotype vaccine (Prevenar®) followed by one dose of the 23-serotype vaccine (Pneumovax® II) 2. One dose of the 23-serotype vaccine (Pneumovax® II) followed by two doses of the 7-serotype vaccine (Prevenar®) 3. One dose of the 7-serotype vaccine (Prevenar®) followed by one dose of the 23-serotype vaccine (Pneumovax® II, followed by a further dose of the 7-serotype vaccine (Prevenar®) All vaccines will be administered at 0, 6 and 12 months. |
| Primary outcome measure(s) | Absolute antibody concentration to Pn23 after a one or 2 dose priming immunisation with Pnc7. |
| Secondary outcome measure(s) |
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 |
| Sources of funding | Wyeth Vaccines (UK) |
| Trial website | http://www.paediatrics.ox.ac.uk/ovg/ |
| Publications |
1. 2011 result in http://www.ncbi.nlm.nih.gov/pubmed/21367726
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22457293 |
| Contact name | Dr Andrew Pollard |
| Address |
Oxford Vaccine Group
Department of Paediatrics University of Oxford Centre for Clinical Vaccinology and Tropical Medicine Churchill Hospital Old Road Headington |
| City/town | Oxford |
| Zip/Postcode | OX3 7LJ |
| Country | United Kingdom |
| Tel | +44 (0)1865 857420 |
| Fax | +44 (0)1865 857420 |
| ovg@paediatrics.ox.ac.uk | |
| Sponsor | University of Oxford (UK) |
| Address |
Clinical Trials Office
Manor House John Radcliffe Hospital Headington |
| City/town | Oxford |
| Zip/Postcode | OX3 7LJ |
| Country | United Kingdom |
| Tel | +44 (0)1865 743004 |
| Fax | +44 (0)1865 743002 |
| heather.house@admin.ox.ac.uk | |
| Sponsor website: | http://www.admin.ox.ac.uk/rso/contactus/ctrg.shtml |
| Date applied | 04/07/2006 |
| Last edited | 05/04/2012 |
| Date ISRCTN assigned | 28/07/2006 |
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| © 2013 ISRCTN unless otherwise stated. | |
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