Babies born early Antibody Response to Men B Vaccinatio
Phase 1
- Conditions
- This study is looking at the vaccine responses of premature infants to the Men B vaccine.Therapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2017-001487-38-GB
- Lead Sponsor
- St George's, University of London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 132
Inclusion Criteria
Premature infant born at <35 weeks gestation
No contraindications to vaccination according to the ‘Green Book’
Willing and able to comply with study procedures
Written informed consent
Are the trial subjects under 18? yes
Number of subjects for this age range: 132
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
Exclusion Criteria
Contraindication to vaccination according to the Green Book
Life-limiting congenital abnormality or condition
Prior diagnosis of an immunodeficiency syndrome
Considered unlikely to complete expected follow up until the end of the study
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