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 | https://doi.org/10.1186/ISRCTN27374886 |
| EudraCT/CTIS number | 2012-003026-25 |
| ClinicalTrials.gov number | NCT01896596 |
| Secondary identifying numbers | 13974 |
- Submission date
- 25/04/2013
- Registration date
- 26/04/2013
- Last edited
- 21/06/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
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
Contact information
Scientific
Centre for Infections
Health Protection Agency
61 Colindale Avenue
London
NW9 5EQ
United Kingdom
| jo.southern@phe.gov.uk |
Study information
| Study design | Randomised interventional study; Design type: Prevention |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| 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 |
| Study acronym | Infanrix-Hexa |
| Study objectives | 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(s) | First MREC approval date 28/09/2012, ref: 12/LO/1132 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 01/06/2013 |
| Completion date | 31/12/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | UK Sample Size: 300 |
| Total final enrolment | 171 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 01/06/2013 |
| Date of final enrolment | 31/12/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
NW9 5EQ
United Kingdom
Sponsor information
Government
Health Protection Agency for Infections
61 Colindale Avenue
London
NW9 5EQ
United Kingdom
| Website | http://www.hpa.org.uk/ |
|---|---|
"ROR" |
https://ror.org/03sbpja79 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
21/06/2019: The total final enrolment was added.
01/03/2019: Basic results link added.
15/01/2018: The primary contact for the study informed us that they will not be keeping the ISRCTN record updated as the trial is registered at clinicaltrials.gov. Please visit this site for up to date information (NCT registration number added).
09/06/2016: Plain English summary added.
