Investigating the immune response to 4CMenB in infants(EUCLIDS)

Phase 1

Active, not recruiting

• Conditions: This study aims to investigate gene expression following vaccination with 4CMenB and relate this to vaccine reactions and to immune response; Therapeutic area: Body processes [G] - Genetic Phenomena [G05]

• Registration Number: EUCTR2014-000126-38-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-04
• Study Completion: 2018-04-27
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Not specified
• Target Recruitment: 187

Inclusion Criteria

•Healthy infants of two Caucasian parents (self-defined by parent) born between 37 and 42 weeks of gestation aged 8-12 weeks at time of first visit
•Parent or legal guardian willing and able to comply with the requirements of the protocol and have internet access for the duration of the study.
•Parent/legal guardian who have given informed consent for their child’s participation in the study

Are the trial subjects under 18? yes
Number of subjects for this age range: 0
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

•Non-Caucasian infants
•Children of parents who are on the delegation log for this study
•Parent/ legal guardian under the age of 18
•History of invasive meningococcal B disease
•Previous vaccination with meningococcal serogroup B vaccine
•History of being a household contact with a case of confirmed bacterial meningitis
•Prior administration of any vaccine or planned administration of any vaccine not specified in the study protocol, with the exception of Hepatitis B vaccine and Influenza vaccines (which can be given 14 days before or after study vaccines), or BCG (which can be administered 28 days before or after study vaccines)
•Prior or planned receipt of any other investigational vaccine or drug
•Confirmed or suspected immunodeficiency
•A family history of congenital or hereditary immunodeficiency, or maternal HIV
•Receipt of more than 1 week of immunosuppressants or immune modifying drugs (e.g. oral prednisolone >0.5ml/kg/day or intravenous glucocorticoid steroid). Nasal, topical or inhaled steroids are allowed.
•History of allergy to any component of the vaccine
•Major congenital defects or serious chronic illness
•History of any neurologic disorders or seizures
•Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period
•Any other condition which, in the opinion of the investigator, may interfere with the ability to fulfil study requirements (this may include plans to move house and language comprehension).
•No internet access for the duration of the study.

Study & Design

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