Prematurity Clinical Trial
— BEAR Men BOfficial 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.
Verified date | November 2020 |
Source | St George's, University of London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 136 |
Est. completion date | August 28, 2020 |
Est. primary completion date | September 2, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 7 Weeks to 11 Weeks |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | St Georges University Hospital NHS Foundation Trust | Tooting | London |
Lead Sponsor | Collaborator |
---|---|
St George's, University of London | GlaxoSmithKline, MeningitisNow, Public Health England |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | hSBA GMT | hSBA GMT one month after completing primary immunisations for relevant 4CMenB (Bexsero®) antigens: fHbp, NadA and PorA | Tested in each infant at 5 months of age (1 month after completion of primary vaccinations) | |
Primary | hSBA proportions | hSBA proportions = 1:4, one month after completing primary immunisations for relevant 4CMenB (Bexsero®) antigens: fHbp, NadA and PorA. | Tested in each infant at 5 months of age (1 month after completion of primary vaccinations) | |
Secondary | 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 | Assessed in each infant for the 7 days following vaccination | |
Secondary | 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 | Assessed in all infants in hospital for 72 hours following vaccination | |
Secondary | Suspicion of sepsis in 7 days following vaccination | The percentage of infants investigated for sepsis and commenced on antibiotics within 7 days of vaccination | Assessed in all infants in the 7 days following vaccination | |
Secondary | 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 | Assessed in all infants in the 28 days following vaccination | |
Secondary | Serious adverse events | The percentage of infants who experience a serious adverse event at any point within the study | Assessed in all infants at the conclusion of the study | |
Secondary | Persistence of hSBA GMTs | hSBA GMTs at 12 months of age (pre booster) for relevant 4CMenB (Bexsero®) antigens: fHbp, NadA and PorA | Assessed in all infants at 12 months of age | |
Secondary | 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 | Assessed in all infants at 12 months of age | |
Secondary | Booster response: hSBA GMTs | hSBA GMTs at 13 months of age (post booster) for relevant 4CMenB (Bexsero®) antigens: fHbp, NadA and PorA; | Assessed in all infants at 13 months of age | |
Secondary | 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. | Assessed in all infants at 13 months of age |
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