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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 13valent 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.
ISRCTN ISRCTN27374886
DOI 10.1186/ISRCTN27374886
ClinicalTrials.gov identifier
EudraCT number 2012-003026-25
Public 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 13valent 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.
Scientific title
Acronym Infanrix-Hexa
Serial number at source 13974
Study hypothesis Infants in the UK are routinely immunised against diphtheria, tetanus, pertussis, polio and Haemophilus influenzae serotype b(Hib) using a 5in1 combination vaccine (Pediacel™) 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 6in1 vaccine (InfanrixHexa™) to replace the current 5in1 vaccine (Pediacel™) 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 InfanrixHexa™ 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.

More details can be found at: http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=13974
Lay summary Not provided at time of registration
Ethics approval First MREC approval date 28/09/2012, ref: 12/LO/1132
Study design Randomised interventional study; Design type: Prevention
Countries of recruitment United Kingdom
Disease/condition/study domain Immune response to vaccines
Participants - inclusion criteria 1. Male or female infants born at term (at least 37 weeks gestation) who are aged <10 weeks and have not yet received their primary immunisations
2. With written informed consent obtained from the parent or legal guardian of the infant to participate in the study
3. Do not fulfil any of the exclusion criteria
Participants - exclusion criteria Participant may not be included in the study if any of the following apply:
1. History of infection with Haemophilus influenzae serotype b (Hib), pneumococcal or meningococcal disease, pertussis, polio, diphtheria, tetanus or hepatitis B
2. History of maternal acute or chronic hepatitis B infection
3. Confirmed or suspected immunosuppressive or immunodeficient condition (including HIV)
4. Bleeding disorders and/or prolonged bleeding time
5. Major congenital defects or chronic disease
6. Premature birth (<37 weeks gestation at birth).
7. Previously received any vaccine (particularly hepatitis B)
8. Unable to obtain sufficient blood sample during >2 of the 4 blood sampling visits

Temporary Exclusion Criterion - Vaccination will be postponed until resolution of fever if axillary/aural temperature is >= 38°C.
Anticipated start date 01/06/2013
Anticipated end date 31/12/2016
Status of trial Ongoing
Patient information material
Target number of participants UK Sample Size: 300
Interventions Vaccines, Babies taking part in this study will be randomly allocated to receive one of 3 MenC or MenC containing vaccines at 3 months of age: NeisVacC™, Menjugate™ or Menitorix™. Recent clinical trials have shown that one dose of NeisVac™ or Menjugate™ given to babies at 3 months of age provides similar protection against MenC disease as two doses.
Primary outcome measure(s) To compare Hib antibody concentrations and MenC-specific antibody titres measured one month after primary immunisation, prior to routine booster vaccination at 12 months of age
Secondary outcome measure(s) Not provided at time of registration
Sources of funding Department of Health (UK) - Policy Research Programme
Trial website
Publications
Contact name Dr  Jo  Southern
  Address Centre for Infections
Health Protection Agency
61 Colindale Avenue
  City/town London
  Zip/Postcode NW9 5EQ
  Country United Kingdom
  Email jo.southern@phe.gov.uk
Sponsor Health Protection Agency (UK)
  Address Health Protection Agency for Infections
61 Colindale Avenue
  City/town London
  Zip/Postcode NW9 5EQ
  Country United Kingdom
  Sponsor website: http://www.hpa.org.uk/
Date applied 25/04/2013
Last edited 26/04/2013
Date ISRCTN assigned 26/04/2013
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