Prems Under New Schedule (PUNS)

Phase 1

• Conditions: These are vaccines routinely given to infants in the UK and are not administered with respect to existing medical condition(s), rather in the prevention of diseases.; MedDRA version: 15.0 Level: LLT Classification code 10027276 Term: Meningococcal meningitis System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Health Care [N] - Environment and Public Health [N06]

• Registration Number: EUCTR2007-007535-23-GB
• Lead Sponsor: St George's University of London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-03-28
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

•Infants born at <35 weeks gestation (i.e. up to and including 34 weeks and 6 days); recruitment will be stratified such that 50% of infants are born at <30 weeks gestational age (i.e. up to and including 29 weeks and 6 days) and 50% of infants are born between 30 weeks and 34 weeks and 6 days gestational age).
•No contraindications to vaccination as specified in the Green Book” (Immunisation Against Infectious Disease, 2006).
•Written informed consent obtained from the parent or legal guardian
•Receipt of previous BCG or Hepatitis B vaccines will not be an exclusion criterion.
•Receipt of immunoglobulin, or corticosteroids will not be an exclusion criterion.
Are the trial subjects under 18? yes
Number of subjects for this age range: 200
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

Contraindications to vaccination as specified in the Green Book” – Immunisation Against Infectious Disease, 2006 HMSO17.

Study & Design

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