Hepatitis B vaccination in infants (version 1.1)

• Research type

  Research Study

• Full title

  A phase IV study to evaluate the primary and booster immune responses of UK infants receiving a licensed 6-in-1 DTaP/IPV/Hib/HBV vaccine(Infanrix-Hexa™) with a 13-valent pneumococcal conjugate vaccine and incorporating a randomisation study of a single dose of 3 different meningococcal group C conjugate vaccines at 3 months of age.

• IRAS ID

  100251

• Contact name

  Elizabeth Miller

• Sponsor organisation

  Public Health England

• Eudract number

  2012-003026-25

• ISRCTN Number

  not issued

• Research summary

  Infants in the UK are routinely immunised against diphtheria, tetanus, pertussis, polio and Haemophilus flunzae serotype b(Hib)using a 5-in-1 combination vaccine (Pediacel?½) given at 2, 3 and 4 months of age. These infants also receive vaccines that protect against meningococcal group C (MenC) and pneumococcal disease as part of this primary schedule. Hepatitis B is an infection of the liver caused by the Hepatitis B virus (HBV). Chronic infection with HBV causes significant morbidity and mortality as there is an increased long-term risk of liver failure, cirrhosis and cancer. The UK currently has a selective HBV immunisation strategy targeting only those considered at high-risk of HBV infection. There is an opportunity to introduce a licensed 6-in-1 vaccine (Infanrix-Hexa?½) to replace the current 5-in-1 vaccine (Pediacel?½) in the infant schedule. This vaccine should protect infants against all the same infections but in addition will protect against hepatitis B. The development of combination vaccines is complex and there is the potential for interactions between the different components of a combination vaccine and also between different vaccines given at the same visit. The proposed study aims to ensure that giving Infanrix-Hexa?½ with MenC and the pneumococcal vaccine as part of UK infant schedule will offer adequate protection against the infections it is designed to protect. In addition, although infants in the UK currently receive 2 doses of MenC vaccine at 3 and 4 months of age, recent studies have shown that a single MenC dose in infancy provides adequate protection and, therefore, the UK infant schedule will soon move to a single MenC vaccine dose given at 3 months of age. As a result, we aim to randomise infants to receive one of 3 licensed MenC vaccines at 3 months of age.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  12/LO/1132

• Date of REC Opinion

  28 Sep 2012

• REC opinion

  Further Information Favourable Opinion