EUCTR2010-023865-22-GBActive, not recruitingPhase 1
A prospective study to evaluate the immune response of UK infants receiving the 13-valent pneumococcal conjugate vaccine as part of their routine primary immunisation schedule at 2 and 4 months (code: P13UK) - P13UK
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Health Protection Agency
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •Male or female infants born at term (at least 37 weeks gestation) aged <6 months:
- •With written informed consent obtained from the parent or legal guardian of the infant to participate in the study and to allow the infant’s General Practitioner (GP) to be informed of participation in the study and be contacted, if required, for confirmation of the vaccination history
- •Who have received all their primary immunisations in the 1st 6 months of life, including:
- •- 3 doses of Pediacel®
- •- 2 doses of Prevenar13®, with the 1st dose given at 6-12 weeks of age and the 2nd
- •dose at 8-12 weeks after the 1st dose
- •- 2 doses of any MenC vaccine
- •Do not fulfil any of the Exclusion Criteria
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Participant may not be included in the study if any of the following apply:
- •History of invasive Haemophilus influenzae serotype b (Hib), pneumococcal or meningococcal disease
- •Confirmed or suspected immunosuppressive or immunodeficient condition (including HIV)
- •Bleeding disorders and/or prolonged bleeding time
- •Major congenital defects or chronic disease
- •Premature birth (<37 weeks gestation at birth)
Investigators
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