Broader Protection Against Pneumococcal Disease: a Follow-on Study

• Research type

  Research Study

• Full title

  A follow-on, multi-centre, open-label, clinical, phase 3 trial to investigate the persistence of serotype-specific antibodies at 40 months of age in children who have received either the 7-valent or the 13-valent pneumococcal conjugate vaccine at 2, 4 and 12 months of age and assessing the immunogenicity of a 13-valent pneumococcal conjugate vaccine booster dose given at 40 months of age

• IRAS ID

  41572

• Contact name

  A J Pollard

• Eudract number

  2009-017498-39

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Children in the UK are routinely immunised with a 7-valent pneumococcal conjugate vaccine that helps prevent against invasive pneumococcal disease (IPD), an important cause of meningitis and septicaemia (blood poisoning). A new version of this vaccine that extends the protection against IPD to 13, rather than 7, serotypes has been developed and assessed in a previous study conducted by the Oxford Vaccine Group. This follow-on study will look at the persistence of serotype-specific antibodies at approximately 40 months of age in children who have received either the 7-valent or the 13-valent pneumococcal conjugate vaccine at 2, 4 and 12 months of age. The study will also assess the immune response to a dose of the 13-valent pneumococcal conjugate vaccine given at 40 months of age. This multicentre study will include at least 5 sites (in Oxford, Bristol, London and Southampton) and we are expecting to recruit approximately 100 children. Two home visits will take place and will involve a blood test (10 mls) followed by a booster dose of PCV13 on Visit 1, and a blood test (10 mls) on Visit 2. The study will take place from March 2010 to March 2011.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  10/H0606/9

• Date of REC Opinion

  18 Mar 2010

• REC opinion

  Further Information Favourable Opinion