Status:
COMPLETED
Hepatitis B Vaccination in Infants
Lead Sponsor:
Public Health England
Collaborating Sponsors:
Department of Health, United Kingdom
Institute of Child Health, London, England
Conditions:
Meningococcal Disease
Pneumococcal Disease
Eligibility:
All Genders
2-3 years
Phase:
PHASE4
Brief Summary
In the UK, infants currently receive a 5-in-1 vaccine (Pediacel) at 2, 3 and 4 months of age, which protects against diphtheria, tetanus, pertussis (whooping cough), polio and Haemophilus influenzae t...
Detailed Description
Infants in the United Kingdom are routinely immunised against diphtheria, tetanus, pertussis (whooping cough), polio and Haemophilus influenzae type b (Hib) as a single 5-in-1 (DTaP5-IPV-Hib) combinat...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Male or female infants born at term (at least 37 weeks gestation) who are aged \<12 weeks and have not yet received their primary immunisations
- With written informed consent obtained from the parent or legal guardian of the infant to participate in the study
- Do not fulfil any of the exclusion criteria.
- Exclusion Criteria
- Participant may not be included in the study if any of the following apply:
- History of infection with Haemophilus influenzae serotype b (Hib), pneumococcal or meningococcal disease, pertussis, polio, diphtheria, tetanus or hepatitis B
- History of maternal acute or chronic hepatitis B infection
- 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).
- Previously received any vaccine (particularly hepatitis B)
Exclusion
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01896596
Start Date
July 1 2013
End Date
April 1 2017
Last Update
October 1 2020
Active Locations (1)
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1
St George's Vaccien Institute
London, United Kingdom