The 6-in-1 Vaccine Study
- Conditions
- Immunogenicity and reactogenicity of concomitantly administered hexavalent and group B meningococcal vaccines in infancy.Therapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2018-003451-38-GB
- Lead Sponsor
- Clinical Trials and Research Governance (CTRG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 240
For recruitment to all study groups, participants MUST FULFILL each of the below criterion:
•Parents/legal guardians are over 16 years of age, and are willing and able to consent to enrol their child/children in the study
•Parents/legal guardians able comply with the requirements of the trial protocol and have internet access for the duration of the study
•Parents/legal guardians are willing to allow their General Practitioner, health visitor and consultant, if appropriate, to be notified of participation in the trial.
•Participants born at greater than or equal to 37 weeks gestation
•Participants are due to receive their primary immunisations, aged 8 to 13 weeks (i.e. the day the child turns 13 weeks of age) at enrolment
Are the trial subjects under 18? yes
Number of subjects for this age range: 240
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
The participant may not enter the trial IF ANY of the following apply:
•Parents/legal guardians of children are on the delegation log of this study
•Confirmed or suspected immunodeficiency
•Fulfil any of the contraindications to vaccination as specified in The Green Book
•Confirmed anaphylactic reaction/s to any constituent/s or excipient/s of the vaccine(s)
•Confirmed anaphylactic reaction to neomycin, streptomycin or polymyxin B (which may be present in trace amounts in the tetanus vaccine), kanamycin, histidine, sodium chloride or sucrose (which may be present in trace amounts in the Meningococcal B vaccine) or to gelatin (which may be present in trace amounts in the MMR vaccine)
•Latex hypersensitivity (the syringe cap of the Meningococcal B vaccine Bexsero may contain natural rubber latex)
•Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial.
•Thrombocytopenia or any other bleeding disorders.
•Child is currently participating in another interventional clinical trial
Temporary exclusions for all groups
For a vaccination visit only (visit 1, 2, 3, and 5)
•Administration of any other vaccine within 14 days prior to study vaccines.
•Scheduled elective surgery, planned admission or other procedures requiring general anaesthesia within 7 days of receiving a vaccine
•Febrile illness (axillary temperature =38.0°C) within the previous 24 hours or on the day of vaccination
For a blood sampling visit only (visit 4 and 6)
Have received parenteral or oral antibiotics within the last 7 days
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method