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Babies Born Early Antibody Response to Men B Vaccination: BEAR Men B

NCT03125616 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2020-12-01

No results posted yet for this study

Summary

In the UK, babies receive their vaccinations according to a standard schedule, irrespective of their gestation at birth. This policy is designed so that all babies are protected as early as possible from vaccine preventable diseases such as polio, diphtheria, tetanus, rotavirus, pertussis (whooping cough), Haemophilus influenzae type B, pneumococcal disease and now meningococcal B disease. The 4CMenB vaccination (Bexsero®) was added to the UK schedule in September 2015 and there has been no research looking at whether the vaccine gives the same protection to babies born early as it does to those born at term. The Investigators want to compare two different schedules of 4CMenB and see if one gives better protection to babies born prematurely. It is possible that an extra 4CMenB dose (i.e. three doses in early infancy instead of two) will offer better protection for premature babies. This is what the Investigators are trying to find out through this study.

Conditions

  • Prematurity
  • Vaccination
  • Meningococcal Disease

Interventions

BIOLOGICAL

4CMenB Vaccine

The infants will receive an intramuscular injection of the 4CMenB vaccine at 2 months

BIOLOGICAL

4CMenB Vaccine

The infants will receive an intramuscular injection of the 4CMenB vaccine at 3 months

BIOLOGICAL

4CMenB Vaccine

The infants will receive an intramuscular injection of the 4CMenB vaccine at 4 months

BIOLOGICAL

4CMenB Vaccine

The infants will receive an intramuscular injection of the 4CMenB vaccine at 12 months

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • MeningitisNow

    collaborator UNKNOWN

  • Public Health England

    collaborator OTHER_GOV

  • St George's, University of London

    lead OTHER

Principal Investigators

  • Paul Heath, MBBS · St George's, University of London

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Weeks
Max Age
11 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2019-09-02
Completion
2020-08-28

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03125616 on ClinicalTrials.gov