6-in-1 Part 2 Vaccine Study

  • Status: Open to Recruitment  
  • Population: Paediatric
  • Disease group: Multiple (diphtheria, tetanus, poliovirus, whooping cough, hepatitis B and Haemophilus influenzae Type B) 
  • Funder: MCM vaccine 
  • Sponsor: University of Oxford 
  • Principal Investigator: Prof. Paul Heath

Study Aims

St George’s University Hospital’s Vaccine Institute is inviting healthy children who have not yet had their 12-month immunisations to take part in the study. 

One of the vaccines currently given at age 12 months in the UK routine immunisation programme is due to be withdrawn in 2025. The routine schedule will therefore be revised. Various options have been considered. This study is to assess a possible new immunisation schedule before it is made routinely available. 

In particular, the study will investigate the “6-in-1” vaccine (which protects against diphtheria, tetanus, poliovirus, whooping cough, hepatitis B and Haemophilus influenzae type b). There are two licensed 6-in-1 vaccines available, Infanrix hexa and Vaxelis. The components of these two vaccines are not quite identical. At present, the same vaccine (either Infanrix hexa or Vaxelis) is recommended to be used for each of the three doses in the initial course (given at ages 2, 3 and 4 months). It is hoped that giving booster doses at 18 months of age will increase the protection against these diseases. If a booster dose is introduced, it will be useful to know whether the two vaccines can be used interchangeably. Our study will investigate this question. If either vaccine can be used as a booster, it makes the delivery of the vaccine programme easier and more flexible; it also ensures that if one of the vaccines becomes unavailable, the other can be used instead. 

What does participating in the study involve?

Participants in the study will be given their routine 12-month vaccinations (apart from Hib/MenC, which the Joint Committee on Vaccination and Immunisation has advised is no longer necessary at this age because of good herd immunity in the UK). At 18 months of age, they will be given 6-in-1 vaccine and MMR vaccine. Participants will also have the option of receiving two doses of a varicella vaccine. Varicella is the virus which causes chickenpox. It is possible varicella vaccination will be added to the routine childhood schedule in future. If your child takes part, after the 18-month vaccinations you will be asked to record symptoms in a diary every day for 7 days, and to record your child’s temperature daily for three weeks. Participants will have two blood tests during the study to assess their immune response. 

For more information, please see the Study Information Booklet.

What can I do if I’m interested in taking part?

If you have read the study information booklet and are interested in participating, please contact the St George’s study team either by Phone (0208 725 5382) or Email (6in1@sgul.ac.uk) to see if your child is eligible to take part. 
Alternatively, you can complete our pre-screening questionnaire (click here). If your child is eligible, a member of the study team will then contact you.