Babies Born Early Antibody Response to Men B Vaccination: BEAR Men B (BEAR Men B)
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ClinicalTrials.gov Identifier: NCT03125616 |
Recruitment Status :
Completed
First Posted : April 24, 2017
Last Update Posted : December 1, 2020
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Condition or disease | Intervention/treatment | Phase |
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Prematurity Vaccination Meningococcal Disease | Biological: 4CMenB Vaccine | Phase 4 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 136 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | This will be an open label, phase IV study. |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
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. |
Actual Study Start Date : | August 1, 2017 |
Actual Primary Completion Date : | September 2, 2019 |
Actual Study Completion Date : | August 28, 2020 |

Arm | Intervention/treatment |
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Active Comparator: Standard UK 4CMenB vaccine
4CMenB (Bexsero®) vaccination at 2 and 4 months and a booster at 12 months .
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Biological: 4CMenB Vaccine
The infants will receive an intramuscular injection of the 4CMenB vaccine at 2 months
Other Name: Bexsero Biological: 4CMenB Vaccine The infants will receive an intramuscular injection of the 4CMenB vaccine at 4 months
Other Name: Bexsero Biological: 4CMenB Vaccine The infants will receive an intramuscular injection of the 4CMenB vaccine at 12 months
Other Name: Bexsero |
Experimental: Additional 4CMenB Vaccine
4CMenB (Bexsero®) vaccination at 2, 3 and 4 months and a booster at 12 months.
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Biological: 4CMenB Vaccine
The infants will receive an intramuscular injection of the 4CMenB vaccine at 2 months
Other Name: Bexsero Biological: 4CMenB Vaccine The infants will receive an intramuscular injection of the 4CMenB vaccine at 3 months
Other Name: Bexsero Biological: 4CMenB Vaccine The infants will receive an intramuscular injection of the 4CMenB vaccine at 4 months
Other Name: Bexsero Biological: 4CMenB Vaccine The infants will receive an intramuscular injection of the 4CMenB vaccine at 12 months
Other Name: Bexsero |
- hSBA GMT [ Time Frame: Tested in each infant at 5 months of age (1 month after completion of primary vaccinations) ]hSBA GMT one month after completing primary immunisations for relevant 4CMenB (Bexsero®) antigens: fHbp, NadA and PorA
- hSBA proportions [ Time Frame: Tested in each infant at 5 months of age (1 month after completion of primary vaccinations) ]hSBA proportions ≥ 1:4, one month after completing primary immunisations for relevant 4CMenB (Bexsero®) antigens: fHbp, NadA and PorA.
- Reactions within 7 days [ Time Frame: Assessed in each infant for the 7 days following vaccination ]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 [ Time Frame: Assessed in all infants in hospital 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 [ Time Frame: Assessed in all infants in the 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 [ Time Frame: Assessed in all infants 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 [ Time Frame: Assessed in all infants at the conclusion of the study ]The percentage of infants who experience a serious adverse event at any point within the study
- Persistence of hSBA GMTs [ Time Frame: Assessed in all infants at 12 months of age ]hSBA GMTs at 12 months of age (pre booster) for relevant 4CMenB (Bexsero®) antigens: fHbp, NadA and PorA
- Persistence of hSBA proportions ≥1:4 [ Time Frame: Assessed in all infants at 12 months of age ]hSBA proportions ≥1:4, at 12 months of age (pre booster) for relevant 4CMenB (Bexsero®) antigens: fHbp, NadA and PorA
- Booster response: hSBA GMTs [ Time Frame: Assessed in all infants at 13 months of age ]hSBA GMTs at 13 months of age (post booster) for relevant 4CMenB (Bexsero®) antigens: fHbp, NadA and PorA;
- Booster response: hSBA proportions ≥1:4 [ Time Frame: Assessed in all infants at 13 months of age ]hSBA proportions ≥1:4, at 13 months of age (post booster) for relevant 4CMenB (Bexsero®) antigens: fHbp, NadA and PorA.

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Ages Eligible for Study: | 7 Weeks to 11 Weeks (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03125616
United Kingdom | |
St Georges University Hospital NHS Foundation Trust | |
Tooting, London, United Kingdom, SW17 0QT |
Principal Investigator: | Paul Heath, MBBS | St George's, University of London |
Responsible Party: | St George's, University of London |
ClinicalTrials.gov Identifier: | NCT03125616 |
Other Study ID Numbers: |
16.0247 2017-001487-38 ( EudraCT Number ) |
First Posted: | April 24, 2017 Key Record Dates |
Last Update Posted: | December 1, 2020 |
Last Verified: | November 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Individual participant data will not be shared with other researchers. |
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 |
Prematurity Vaccination |
Meningococcal Infections Premature Birth Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications Neisseriaceae Infections Gram-Negative Bacterial Infections |
Bacterial Infections Bacterial Infections and Mycoses Infections Vaccines Immunologic Factors Physiological Effects of Drugs |