Men B vaccination in preterm infants: a comparison of two schedules

Babies born Early Antibody Response to Men B vaccination: BEAR Men B

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14943533

Enrollment

132

Registered

2019-07-10

Start date

2017-08-01

Completion date

Unknown

Last updated

2021-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meningitis Infections and Infestations Meningitis

Interventions

Babies will be randomised in a 1:1 ratio to receive two doses (at 2 and 4 months) or three doses (at 2, 3 and 4 months) of Men B vaccine (Bexsero) in their primary vaccination series. All babies will

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Premature infant born at <35 weeks gestation 2. No contraindications to vaccination according to the ‘Green Book’ 3. Willing and able to comply with study procedures 4. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Contraindication to vaccination according to the Green Book 2. Life-limiting congenital abnormality or condition 3. Prior diagnosis of an immunodeficiency syndrome 4. Considered unlikely to complete expected follow up until the end of the study

Design outcomes

Primary

Measure	Time frame
Antibody response to Men B vaccination assessed using serum bactericidal antibody (SBA) assays performed on samples collected at 5 months (post primary), 12 months (pre-booster) and 13 months (post booster): 1. hSBA GMTs 1 month after completion of primary immunisations for relevant Bexsero antigens: fHbp, NadA and PorA 2. hSBA proportions =1:4, at 1 month after completion of primary immunisations for relevant Bexsero antigens: fHbp, NadA and PorA	—

Measure

Time frame

Antibody response to Men B vaccination assessed using serum bactericidal antibody (SBA) assays performed on samples collected at 5 months (post primary), 12 months (pre-booster) and 13 months (post booster): 1. hSBA GMTs 1 month after completion of primary immunisations for relevant Bexsero antigens: fHbp, NadA and PorA 2. hSBA proportions =1:4, at 1 month after completion of primary immunisations for relevant Bexsero antigens: fHbp, NadA and PorA

—

Secondary

Measure	Time frame
Local and systemic effects of the vaccine collected using a diary card completed for the 7 days following each set of vaccinations: 1. The percentage of infants presenting with fever, local reactions and non-febrile systemic reactions within the 7 days following each Bexsero® vaccine dose 2. The percentage of inpatients who have a change/deterioration in cardiorespiratory status within the 72 hours following each Bexsero® vaccine dose 3. The percentage of infants investigated for sepsis and commenced on antibiotics within 7 days of Bexsero® vaccination 4. hSBA GMTs at 12 months of chronological age (pre booster) for relevant Bexsero® antigens: fHbp, NadA and PorA 5. hSBA proportions =1:4, at 12 months of chronological age (pre booster) for relevant Bexsero® antigens: fHbp, NadA and PorA 6. hSBA GMTs at 13 months of chronological age (4-6 weeks post booster) for relevant Bexsero® antigens: fHbp, NadA and PorA 7. hSBA proportions =1:4, at 13 months of age (post booster) for relevant Bexsero® antigens: fHbp, NadA and PorA	—

Measure

Time frame

Local and systemic effects of the vaccine collected using a diary card completed for the 7 days following each set of vaccinations: 1. The percentage of infants presenting with fever, local reactions and non-febrile systemic reactions within the 7 days following each Bexsero® vaccine dose 2. The percentage of inpatients who have a change/deterioration in cardiorespiratory status within the 72 hours following each Bexsero® vaccine dose 3. The percentage of infants investigated for sepsis and commenced on antibiotics within 7 days of Bexsero® vaccination 4. hSBA GMTs at 12 months of chronological age (pre booster) for relevant Bexsero® antigens: fHbp, NadA and PorA 5. hSBA proportions =1:4, at 12 months of chronological age (pre booster) for relevant Bexsero® antigens: fHbp, NadA and PorA 6. hSBA GMTs at 13 months of chronological age (4-6 weeks post booster) for relevant Bexsero® antigens: fHbp, NadA and PorA 7. hSBA proportions =1:4, at 13 months of age (post booster) for relevant Bexsero® antigens: fHbp, NadA and PorA

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026