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 |
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DOI | https://doi.org/10.1186/ISRCTN78768849 |
Secondary identifying numbers | 6097A1-800 |
- Submission date
- 04/07/2006
- Registration date
- 28/07/2006
- Last edited
- 24/07/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Andrew Pollard
Scientific
Scientific
Oxford Vaccine Group
Department of Paediatrics
University of Oxford
Centre for Clinical Vaccinology and Tropical Medicine
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LJ
United Kingdom
Phone | +44 (0)1865 857420 |
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ovg@paediatrics.ox.ac.uk |
Study information
Study design | Randomised clinical trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | |
Study acronym | Protecting adults against pneumococcal disease |
Study objectives | 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). |
Ethics approval(s) | Ethics approval received from the Oxfordshire A Local Research Ethics Committee (LREC) on the 14th September 2006 (ref: 06/Q1604/121). |
Health condition(s) or problem(s) studied | Pneumococcal disease |
Intervention | 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. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Heptavalent pneumococcal conjugate vaccine (Prevenar ®), 23-valent pneumococcal polysaccharide vaccine (Pneumovax® II) |
Primary outcome measure | Absolute antibody concentration to Pn23 after a one or 2 dose priming immunisation with Pnc7. |
Secondary outcome measures | 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 |
Overall study start date | 01/09/2006 |
Completion date | 31/08/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 348 |
Key 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 |
Key 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 |
Date of first enrolment | 01/09/2006 |
Date of final enrolment | 31/08/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Oxford Vaccine Group
Oxford
OX3 7LJ
United Kingdom
OX3 7LJ
United Kingdom
Sponsor information
University of Oxford (UK)
University/education
University/education
Clinical Trials Office
Manor House
John Radcliffe Hospital
Headington
Oxford
OX3 7LJ
England
United Kingdom
Phone | +44 (0)1865 743004 |
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heather.house@admin.ox.ac.uk | |
Website | http://www.admin.ox.ac.uk/rso/contactus/ctrg.shtml |
https://ror.org/052gg0110 |
Funders
Funder type
Industry
Wyeth Vaccines (UK)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | result | 15/03/2011 | Yes | No | |
Results article | results | 01/05/2012 | Yes | No | |
Results article | results | 01/03/2013 | Yes | No |