Plain English Summary
Background and study aims
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 schedule. Hepatitis B is an infection of the liver caused by the Hepatitis B virus (HBV). Chronic (long-term) infection with HBV increases the 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 aim of this study is 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 two 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 randomly allocate infants to receive one of three licensed MenC vaccines at 3 months of age.
Who can participate?
Infants born at term (at least 37 weeks gestation) and aged less than 10 weeks who have not yet received their primary immunisations.
What does the study involve?
Infants are randomly allocated to receive one of three MenC or MenC-containing vaccines at 3 months of age: NeisVacC™, Menjugate™ or Menitorix™. Hib and MenC antibody levels are measured one month later, before routine booster vaccination at 12 months of age.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Health Protection Agency (UK)
When is the study starting and how long is it expected to run for?
June 2013 to December 2016
Who is funding the study?
Department of Health (UK)
Who is the main contact?
Dr Jo Southern
jo.southern@phe.gov.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Jo Southern
ORCID ID
Contact details
Centre for Infections
Health Protection Agency
61 Colindale Avenue
London
NW9 5EQ
United Kingdom
-
jo.southern@phe.gov.uk
Additional identifiers
EudraCT number
2012-003026-25
ClinicalTrials.gov number
NCT01896596
Protocol/serial number
13974
Study information
Scientific 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
Acronym
Infanrix-Hexa
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.
Ethics approval
First MREC approval date 28/09/2012, ref: 12/LO/1132
Study design
Randomised interventional study; Design type: Prevention
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Immune response to vaccines
Intervention
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.
Intervention type
Biological/Vaccine
Phase
Drug names
Primary outcome measure
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 measures
Not provided at time of registration
Overall trial start date
01/06/2013
Overall trial end date
31/12/2016
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
UK Sample Size: 300
Participant exclusion criteria
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.
Recruitment start date
01/06/2013
Recruitment end date
31/12/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Health Protection Agency
London
NW9 5EQ
United Kingdom
Sponsor information
Organisation
Health Protection Agency (UK)
Sponsor details
Health Protection Agency for Infections
61 Colindale Avenue
London
NW9 5EQ
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Department of Health (UK) - Policy Research Programme
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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