A new combination vaccine against 6 childhood diseases

• Research type

  Research Study

• Full title

  A phase II, open-label, randomized, multicentre study to evaluate the feasibility of GSK Biologicals DTPa-IPV/Hib-MenC-TT vaccine co-administered with Prevenar compared with Pediacel co-administered with Menjugate and Prevenar, when given in healthy infants as a three-dose primary vaccination course at 2, 3 and 4 months of age and to evaluate Menitorix given to these children as a booster dose at 12 months of age.

• IRAS ID

  9458

• Contact name

  Andrew J Pollard

• Sponsor organisation

  GlaxoSmithKline Biologicals

• Eudract number

  2008-003741-87

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Currently in the UK, infants receive a vaccine covering diphtheria, tetanus, pertussis (whooping cough), poliovirus types 1, 2 and 3 and haemophilus flunzae type b (Hib) at 2, 3 and 4 months of age. They also receive a vaccine against meningococcal serogroup C (MenC) at 3 and 4 months of age, and a separate pneumococcal conjugate vaccine (PCV) at 2 and 4 months of age. This study will evaluate the feasibility of using a combination vaccine covering diphtheria, tetanus, pertussis, poliovirus types 1, 2 and 3, Hib and MenC when co-administered with PCV. The aim of this study is to determine if the combination vaccine is safe and immunogenic, as this would reduce the total number of injections that infants receive in the primary course of immunisations from 7 to 5. This would potentially improve coverage rates by making immunisation schedules more acceptable to parents.This study will be a randomised controlled trial, but not blinded. The control group will receive vaccines according to the current UK immunisation schedule (as outlined above). The study group will receive the combination vaccine at 2, 3 and 4 months of age as well as PCV at 2 and 4 months of age. The study will also evaluate the safety and immunogenicity of a combined Hib and MenC booster vaccine at 12 months of age following the two different priming schedules. This vaccine is currently used in the routine infant immunisation schedule along with a PCV booster and MMR vaccine which are also given at around 1 year of age.Follow-up of study participants will be until 13 months of age, 1 month following the Hib-MenC booster. Safety data will be collected throughout the duration of the study. Blood samples will be drawn at 4, 5, 12 and 13 months of age.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  09/H0606/24

• Date of REC Opinion

  2 Apr 2009

• REC opinion

  Further Information Favourable Opinion