The 6-in-1 Part 2 Vaccine Study University Hospital Southampton NHS Foundation Trust

The 6-in-1 Part 2 Vaccine Study University Hospital Southampton NHS Foundation Trust

Would you like to participate in a study which will help to guide decisions about the future UK immunisation schedule? University Hospital Southampton NHS Foundation Trust is inviting healthy children, who are about 12 months old, to take part in this research study.

One of the vaccines currently given to 12-month-old children in the UK routine immunisation programme, Menitorix, will no longer be available after 2025. Menitorix protects against two infections, Haemophilus influenzae type b (Hib) and group C meningococcus (MenC). The immunisation programme will therefore need to be modified. The Joint Committee on Vaccination and Immunisation (JCVI), the independent expert group which advises on vaccination policy in the UK, has considered various possible options for adapting the current schedule. This study is to evaluate the proposed schedule which is most likely to be adopted.

The JCVI has suggested that a new vaccination timepoint could be included in the routine schedule, when children are 18 months old. Two vaccines would be given at this age: a second dose of measles, mumps, rubella (MMR) vaccine, and a booster dose of “6-in-1” vaccine (which protects against diphtheria, tetanus, poliovirus, whooping cough, hepatitis B and Hib). It is hoped that giving booster doses at 18 months of age will increase protection against these diseases.

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 infant course (given at ages 2, 3 and 4 months). If a booster dose is introduced at 18 months of age, it will be valuable to know whether the two vaccines can be used interchangeably. This study will investigate this question. If either vaccine can be used for the 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.

Participants in the study will be given their routine 12-month vaccinations (apart from Hib/MenC). The JCVI has advised that the 12-month Hib/MenC vaccination is no longer necessary because of good herd immunity in the UK. At 18 months of age, participants will be given 6-in-1 vaccine and MMR vaccine. Two doses of a varicella vaccine will be offered to all participants. Varicella is the virus which causes chickenpox. Varicella vaccination is not currently routinely offered to all children in UK, but it is possible that the JCVI will recommend that it becomes part of the routine immunisation 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. Children will have two blood tests during the study to assess their immune response to the different components of the vaccines.

Before you decide whether your child should take part, it is important for you to understand exactly what the study is about and what participation would involve. Participation in the study is voluntary; if enrolled, your child may withdraw at any time. If you are interested in this study, the full study information booklet is available HERE If you have read the study information booklet and are interested in participating, please answer the questions below to see if your child is eligible to take part: If you would like to discuss any aspect of the study, please contact us by email or phone: Email: 6in1vaccinestudy@uhs.nhs.uk  Telephone: 02381 204 989

Many thanks,

University Hospital Southampton NHS Foundation Trust is inviting healthy children

 

Screening Questionnaire Part 1

Answers to Part 1 of this questionnaire (which does not collect any identifiable information such as name/address) will be stored on a secure University of Oxford server. They will be deleted at the end of the study recruitment period for all participants who do not proceed to participate in the study.

 

Thank you for your interest in our study. Based on your responses, you may be eligible to participate. A second part to this questionnaire will follow shortly.

 

Thank you for your interest in our study. Based on your responses, you might be eligible to participate. A second part to this questionnaire will follow shortly.

 

Thank you for your interest in our study. Based on your responses, you are not eligible to take part in this study.

 

Screening Questionnaire Part 2

To ensure that your child is eligible to take part in this study we need to know which 6-in-1 vaccine your child received for their baby immunisations. If you are interested in your child taking part, please email a photo of your child’s baby immunisations from their “red book” to 6in1vaccinestudy@uhs.nhs.uk. Please write “The 6-in-1 Part 2 Vaccine Study” as the title of your email and include your child’s name in the message. The photographs below show what to do.

Thank you for your interest in our study. Based on your responses, your child may be eligible to participate. Please complete the questions below. Please read the study information booklet. We will arrange to contact you.

 

Thank you for your interest in our study. Based on your responses, you are not eligible to take part in this study.

8 + 10 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.

Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, University of Oxford, OX3 7LE.

This unit receives National Institute for Health Research CTU Support Funding. This funding has been awarded to support the unit in developing and supporting NIHR trials.