The 6-in-1 Part 2 Vaccine Study
Research type
Research Study
Full title
Heterologous Boosting for Hexavalent Paediatric Vaccines in the UK Schedule
IRAS ID
1006942
Contact name
Rinn Song
Contact email
Sponsor organisation
University of Oxford, Research Governance, Ethics & Assurance (RGEA) Team
Eudract number
2022-003425-22
Research summary
A vaccine protecting against Haemophilus influenzae type b (Hib) and group C meningococcus (MenC), currently given in the UK routine immunisation programme at age 12 months, branded Menitorix, will be unavailable from 2025. The Joint Committee on Vaccination and Immunisation (JCVI) has considered options for adapting the current schedule. This study will evaluate a proposed schedule before its implementation.
The JCVI suggests that MenC vaccination is no longer required in the UK infant schedule, as a successful vaccination programme in adolescents has led to effective “herd immunity” against MenC. The JCVI also suggests a new vaccination timepoint in the routine schedule at age 18 months, to give a second dose of measles, mumps, rubella (MMR) vaccine and a booster dose of “6-in-1” vaccine (which protects against diphtheria, tetanus, poliovirus, pertussis, hepatitis B and Hib). Moving forward the second dose of MMR vaccine (currently given at pre-school age) may improve vaccination uptake. An initial course of the 6-in-1 vaccine is currently routinely given at 2, 3 and 4 months of age. The boost to Hib immunity currently achieved with Menitorix may instead be achievable by giving the 6-in-1 vaccine at 18 months.
There are two licensed 6-in-1 vaccines, Infanrix hexa and Vaxelis, whose components differ. Currently, the same vaccine is recommended for each of the initial three doses. This study will investigate whether the vaccines may be used interchangeably for the booster, which would facilitate delivery of the vaccine programme.
Participants will be given the vaccinations routinely scheduled at 12 months (except Menitorix). At age 18 months, they will be given either Infanrix hexa or Vaxelis (determined by randomisation) and MMR vaccine. Participants will also be offered two doses of chickenpox vaccine (which is not routinely given in UK) as an optional benefit . Blood samples will be taken at ages 18 and 19 months to assess immune responses to the vaccines.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
23/EE/0121
Date of REC Opinion
30 Aug 2023
REC opinion
Further Information Favourable Opinion