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	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

Study website

Contact information

Dr Andrew Pollard
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
Email	ovg@paediatrics.ox.ac.uk

Study information

Study design	Randomised clinical trial
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
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

Sponsor information

University of Oxford (UK)
University/education

Clinical Trials Office
Manor House
John Radcliffe Hospital
Headington
Oxford
OX3 7LJ
England
United Kingdom

Phone	+44 (0)1865 743004
Email	heather.house@admin.ox.ac.uk
Website	http://www.admin.ox.ac.uk/rso/contactus/ctrg.shtml
"ROR"	https://ror.org/052gg0110

Funders

Funder type

Industry

Wyeth Vaccines (UK)

No information available

Results and Publications

Intention to publish date
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	Peer reviewed?	Patient-facing?
Results article	result	15/03/2011	Yes	No
Results article	results	01/05/2012	Yes	No
Results article	results	01/03/2013	Yes	No