Study to evaluate the immune response of infants to a new infant immunisation schedule which includes a new vaccine protecting against hepatitis B and a reduced dose schedule for meningococcal group C conjugate vaccine.
- Conditions
- ot applicableTherapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2012-003026-25-GB
- Lead Sponsor
- Health Protection Agency
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 171
1. Male or female infants born at term (at least 37 weeks gestation) who aged <12 weeks and have not yet received their primary immunisations
2. Written informed consent obtained from the parent or legal guardian
3. Do not fulfil any of the exclusion criteria
Are the trial subjects under 18? yes
Number of subjects for this age range: 300
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
Participant may not be included in the study if any of the following apply:
1. History of infection with Haemophilus influenzae serotype b (Hib), pneumococcal or meningococcal disease, pertussis, polio, diphtheria, tetanus or hepatitis B
2. History of maternal acute or chronic hepatitis B infection
3. Confirmed or suspected immunosuppressive or immunodeficient condition (including HIV)
4. Bleeding disorders and/or prolonged bleeding time
5. Major congenital defects or chronic disease
6. Premature birth (<37 weeks gestation at birth)
7. Previously received any vaccine(particularly hepatitis B)
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