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

Primary Purpose

Prematurity, Vaccination, Meningococcal Disease

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
4CMenB Vaccine
4CMenB Vaccine
4CMenB Vaccine
4CMenB Vaccine
Sponsored by
St George's, University of London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prematurity focused on measuring Prematurity, Vaccination

Eligibility Criteria

7 Weeks - 11 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Premature infant born at <35 weeks gestation
  • No contraindications to vaccination according to the 'Green Book'
  • Willing and able to comply with study procedures
  • Written informed consent

Exclusion Criteria:

  • Contraindication to vaccination according to the Green Book
  • Life-limiting congenital abnormality or condition
  • Prior diagnosis of an immunodeficiency syndrome
  • Considered unlikely to complete expected follow up until the end of the study

Sites / Locations

  • St Georges University Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard UK 4CMenB vaccine

Additional 4CMenB Vaccine

Arm Description

4CMenB (Bexsero®) vaccination at 2 and 4 months and a booster at 12 months .

4CMenB (Bexsero®) vaccination at 2, 3 and 4 months and a booster at 12 months.

Outcomes

Primary Outcome Measures

hSBA GMT
hSBA GMT one month after completing primary immunisations for relevant 4CMenB (Bexsero®) antigens: fHbp, NadA and PorA
hSBA proportions
hSBA proportions ≥ 1:4, one month after completing primary immunisations for relevant 4CMenB (Bexsero®) antigens: fHbp, NadA and PorA.

Secondary Outcome Measures

Reactions within 7 days
The percentage of infants experiencing fever, local reactions and non-febrile systemic reactions within the 7 days following each vaccine dose
Cardiorespiratory status for 72 hours following vaccination
The percentage of inpatients experiencing change / deterioration in cardiorespiratory status within the 72 hours following each vaccine dose
Suspicion of sepsis in 7 days following vaccination
The percentage of infants investigated for sepsis and commenced on antibiotics within 7 days of vaccination
Fever and/or suspicion of sepsis in the 28 days following vaccination
The percentage of infants who experience fever and/or are investigated for sepsis and commenced on antibiotics within 28 days of vaccination
Serious adverse events
The percentage of infants who experience a serious adverse event at any point within the study
Persistence of hSBA GMTs
hSBA GMTs at 12 months of age (pre booster) for relevant 4CMenB (Bexsero®) antigens: fHbp, NadA and PorA
Persistence of hSBA proportions ≥1:4
hSBA proportions ≥1:4, at 12 months of age (pre booster) for relevant 4CMenB (Bexsero®) antigens: fHbp, NadA and PorA
Booster response: hSBA GMTs
hSBA GMTs at 13 months of age (post booster) for relevant 4CMenB (Bexsero®) antigens: fHbp, NadA and PorA;
Booster response: hSBA proportions ≥1:4
hSBA proportions ≥1:4, at 13 months of age (post booster) for relevant 4CMenB (Bexsero®) antigens: fHbp, NadA and PorA.

Full Information

First Posted
April 19, 2017
Last Updated
November 30, 2020
Sponsor
St George's, University of London
Collaborators
GlaxoSmithKline, MeningitisNow, Public Health England
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1. Study Identification

Unique Protocol Identification Number
NCT03125616
Brief Title
Babies Born Early Antibody Response to Men B Vaccination: BEAR Men B
Acronym
BEAR Men B
Official Title
Babies Born Early Antibody Response to Men B Vaccination: A Phase IV Multicentre Randomised Study to Evaluate the Primary and Booster Immune Responses in UK Preterm Infants Receiving Routine Immunisations and Incorporating a Three Dose Versus a Two Dose Schedule of 4CMenB (Bexsero®) for Primary Immunisation.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
September 2, 2019 (Actual)
Study Completion Date
August 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St George's, University of London
Collaborators
GlaxoSmithKline, MeningitisNow, Public Health England

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
This will be an open label, phase IV study. After appropriate consent, 132 premature infants born at <35 weeks gestation (i.e. up to 34 weeks and 6 days), 50% <30 weeks gestation (i.e. up to 29 weeks and 6 days) will be randomised to 1 of 2 4CMen B schedules either at 2,4 and 12 months or 2,3,4 and 12 months. Babies will remain in the study for around 12 months, from recruitment to 13 months of age. All visits can be performed at the participant's home or in clinic, depending on the preference of the parents and study team. Blood samples will be obtained at 5 months of age (post primary sample), 12 months (persistence sample) and 13 months (post booster sample). Reactogenicity and safety will be assessed by caregiver completion of a 7-day diary after each vaccine dose. Inpatients will be monitored for cardiorespiratory events for 72 hours after vaccination by healthcare staff and this information will be collected on the CRF. This will include details of oxygen saturations, heart rate, respiratory rate and details of any episodes of desaturation, bradycardia or apnoea. Particular emphasis will be placed on rates, timing and intensity of fever and other adverse reactions in the first 24 hours after vaccination, because this remains a cause of great concern amongst neonatologists.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity, Vaccination, Meningococcal Disease
Keywords
Prematurity, Vaccination

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
This will be an open label, phase IV study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard UK 4CMenB vaccine
Arm Type
Active Comparator
Arm Description
4CMenB (Bexsero®) vaccination at 2 and 4 months and a booster at 12 months .
Arm Title
Additional 4CMenB Vaccine
Arm Type
Experimental
Arm Description
4CMenB (Bexsero®) vaccination at 2, 3 and 4 months and a booster at 12 months.
Intervention Type
Biological
Intervention Name(s)
4CMenB Vaccine
Other Intervention Name(s)
Bexsero
Intervention Description
The infants will receive an intramuscular injection of the 4CMenB vaccine at 2 months
Intervention Type
Biological
Intervention Name(s)
4CMenB Vaccine
Other Intervention Name(s)
Bexsero
Intervention Description
The infants will receive an intramuscular injection of the 4CMenB vaccine at 3 months
Intervention Type
Biological
Intervention Name(s)
4CMenB Vaccine
Other Intervention Name(s)
Bexsero
Intervention Description
The infants will receive an intramuscular injection of the 4CMenB vaccine at 4 months
Intervention Type
Biological
Intervention Name(s)
4CMenB Vaccine
Other Intervention Name(s)
Bexsero
Intervention Description
The infants will receive an intramuscular injection of the 4CMenB vaccine at 12 months
Primary Outcome Measure Information:
Title
hSBA GMT
Description
hSBA GMT one month after completing primary immunisations for relevant 4CMenB (Bexsero®) antigens: fHbp, NadA and PorA
Time Frame
Tested in each infant at 5 months of age (1 month after completion of primary vaccinations)
Title
hSBA proportions
Description
hSBA proportions ≥ 1:4, one month after completing primary immunisations for relevant 4CMenB (Bexsero®) antigens: fHbp, NadA and PorA.
Time Frame
Tested in each infant at 5 months of age (1 month after completion of primary vaccinations)
Secondary Outcome Measure Information:
Title
Reactions within 7 days
Description
The percentage of infants experiencing fever, local reactions and non-febrile systemic reactions within the 7 days following each vaccine dose
Time Frame
Assessed in each infant for the 7 days following vaccination
Title
Cardiorespiratory status for 72 hours following vaccination
Description
The percentage of inpatients experiencing change / deterioration in cardiorespiratory status within the 72 hours following each vaccine dose
Time Frame
Assessed in all infants in hospital for 72 hours following vaccination
Title
Suspicion of sepsis in 7 days following vaccination
Description
The percentage of infants investigated for sepsis and commenced on antibiotics within 7 days of vaccination
Time Frame
Assessed in all infants in the 7 days following vaccination
Title
Fever and/or suspicion of sepsis in the 28 days following vaccination
Description
The percentage of infants who experience fever and/or are investigated for sepsis and commenced on antibiotics within 28 days of vaccination
Time Frame
Assessed in all infants in the 28 days following vaccination
Title
Serious adverse events
Description
The percentage of infants who experience a serious adverse event at any point within the study
Time Frame
Assessed in all infants at the conclusion of the study
Title
Persistence of hSBA GMTs
Description
hSBA GMTs at 12 months of age (pre booster) for relevant 4CMenB (Bexsero®) antigens: fHbp, NadA and PorA
Time Frame
Assessed in all infants at 12 months of age
Title
Persistence of hSBA proportions ≥1:4
Description
hSBA proportions ≥1:4, at 12 months of age (pre booster) for relevant 4CMenB (Bexsero®) antigens: fHbp, NadA and PorA
Time Frame
Assessed in all infants at 12 months of age
Title
Booster response: hSBA GMTs
Description
hSBA GMTs at 13 months of age (post booster) for relevant 4CMenB (Bexsero®) antigens: fHbp, NadA and PorA;
Time Frame
Assessed in all infants at 13 months of age
Title
Booster response: hSBA proportions ≥1:4
Description
hSBA proportions ≥1:4, at 13 months of age (post booster) for relevant 4CMenB (Bexsero®) antigens: fHbp, NadA and PorA.
Time Frame
Assessed in all infants at 13 months of age

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Weeks
Maximum Age & Unit of Time
11 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Premature infant born at <35 weeks gestation No contraindications to vaccination according to the 'Green Book' Willing and able to comply with study procedures Written informed consent Exclusion Criteria: Contraindication to vaccination according to the Green Book Life-limiting congenital abnormality or condition Prior diagnosis of an immunodeficiency syndrome Considered unlikely to complete expected follow up until the end of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Heath, MBBS
Organizational Affiliation
St George's, University of London
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Georges University Hospital NHS Foundation Trust
City
Tooting
State/Province
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared with other researchers.
Links:
URL
https://www.gov.uk/government/publications/meningococcal-the-green-book-chapter-22
Description
Meningococcal: the green book, chapter 22

Learn more about this trial

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

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