A Study of the Interaction between BCG And Meningitis C immunisation: BAM

Phase 1

• Conditions: Vaccine responses; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2013-003488-71-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-05
• Study Completion: 2018-06-27
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 28

Inclusion Criteria

• Healthy male or female babies aged 7 days or under
• Born at term (= 36 completed weeks of gestation)
• Valid informed consent provided by an individual with parental responsibility (parent or legal guardian)
• Living within the Thames Valley region at enrolment without intention to move out of this region during the course of the study
• Parents or legal guardians must be aged 18 years or over
• Parent or legal guardian is able (in the Investigator’s opinion) and willing to comply with all study requirements
• Parent or legal guardian consent provided for General Practitioner and consultant, if appropriate, to be notified of participation in the study
• Parent or legal guardian consent to review hospital birth records before enrolment and inform GP or Consultant of involvement in study, if appropriate
Are the trial subjects under 18? yes
Number of subjects for this age range: 30
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

• Confirmed, suspected or significant risk of immunodeficiency
(including but not limited to: maternal history of Human Immunodeficiency Virus infection, family history of congenital or hereditary immunodeficiency and receipt of significant immunosuppressive medication by the participant during the study, or by the mother prior to delivery)
• Receipt of BCG or another live vaccine prior to enrolment
• Receipt of any vaccine, either prior to enrolment or planned during the study, except for:
- those listed in the study protocol at the times indicated
- hepatitis A or B vaccine or influenza vaccine.
• Receipt prior to enrolment, or planned receipt during the study, of monoclonal antibodies, immunoglobulin or any blood product
• A baby who would normally be offered BCG at birth under current Department of Health guidance3. This means:
- babies living in an area of the UK with an annual incidence of TB >40 / 100,000 or
- babies who have a parent or grandparent who was born in a country with an annual incidence of TB >40 / 100,000
• Confirmed or suspected household contact with active TB
• Confirmed or suspected anaphylaxis to any component of BCG or other study vaccine
• Any confirmed or suspected serious medical condition (including seizures, neurological conditions, major congenital abnormalities or malignancy)
• Any condition significantly increasing the risk of intussusception (including previous history of intussusception, known malrotation or other significant anatomical gastrointestinal abnormality)
• Receipt of systemic antimicrobial medication since birth
• Parents or legal guardians should not be members of the study team or named on the study delegation log
• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the potential participant (or carer) at risk because of participation in the study, or may influence the result of the study, or the potential participant’s ability to participate in the study.
• A potential participant who has participated or is participating in another research study involving an investigational product

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified