Condition category
Infections and Infestations
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Andrew Pollard


Contact details

Oxford Vaccine Group
Department of Paediatrics
University of Oxford
Centre for Clinical Vaccinology and Tropical Medicine
Churchill Hospital
Old Road
United Kingdom
+44 (0)1865 857420

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title


Protecting adults against pneumococcal disease

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).

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

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Pneumococcal disease


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



Not Specified

Drug names

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 trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant 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

Participant type


Age group




Target number of participants


Participant 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

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Oxford Vaccine Group
United Kingdom

Sponsor information


University of Oxford (UK)

Sponsor details

Clinical Trials Office
Manor House
John Radcliffe Hospital
United Kingdom
+44 (0)1865 743004

Sponsor type




Funder type


Funder name

Wyeth Vaccines (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

1. 2011 result in
2. 2012 results in
3. 2013 results in

Publication citations

  1. Result

    Lazarus R, Clutterbuck E, Yu LM, Bowman J, Bateman EA, Diggle L, Angus B, Peto TE, Beverley PC, Mant D, Pollard AJ, A randomized study comparing combined pneumococcal conjugate and polysaccharide vaccination schedules in adults., Clin. Infect. Dis., 2011, 52, 6, 736-742, doi: 10.1093/cid/cir003.

  2. Results

    Clutterbuck EA, Lazarus R, Yu LM, Bowman J, Bateman EA, Diggle L, Angus B, Peto TE, Beverley PC, Mant D, Pollard AJ, Pneumococcal conjugate and plain polysaccharide vaccines have divergent effects on antigen-specific B cells., J. Infect. Dis., 2012, 205, 9, 1408-1416, doi: 10.1093/infdis/jis212.

  3. Results

    Trück J, Lazarus R, Clutterbuck EA, Bowman J, Kibwana E, Bateman EA, Pollard AJ, The zwitterionic type I Streptococcus pneumoniae polysaccharide does not induce memory B cell formation in humans., Immunobiology, 2013, 218, 3, 368-372, doi: 10.1016/j.imbio.2012.05.008.

Additional files

Editorial Notes