Optimal Timing for Adolescent Meningococcal B vaccination schedule (BOOST MenB study)
A randomised controlled trial to assess the persistence of Neisseria bactericidal antibodies at 12-months post two doses of meningococcal B vaccine following two different dosing schedules (short vs long interval) in Adolescents.
University of Adelaide
284 participants
Jan 5, 2026
Interventional
Conditions
Summary
The BOOST MenB Study is a randomised controlled trial investigating the best timing of the Meningococcal B (Bexsero®) vaccine in adolescents. Currently, two doses are given approximately 2-3 months apart, around age 15-16. This study aims to determine if spacing the doses several years apart would provide longer-lasting protection. It will also explore whether Bexsero® offers cross-protection against gonorrhoea.
Eligibility
Inclusion Criteria3
- Children aged 11-13 years (not yet 14) at randomisation.
- The participant and parent (and/or legal guardian) are capable of understanding the written informed consent, providing signed and witnessed written informed consent and assent, and understanding and complying with protocol requirements.
- Participant is willing to receive two doses of 4CMenB vaccine and up to four blood samples throughout the study duration.
Exclusion Criteria8
- Received a prior 4CMenB vaccine in the previous 10 years
- Previously received two or more 4CMenB containing vaccines at least 8 weeks apart
- Immunodeficiency condition or immunosuppressive therapy.
- Prior history of invasive meningococcal disease.
- Participation in any other study receiving an investigational drug/vaccine
- Known pregnancy
- Any contraindication to receiving 4CMenB vaccine.
- Any other condition that may interfere with the immune system
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Interventions
The intervention is the extended-interval 4CMenB (Bexsero®) vaccination schedule, defined in the protocol as: Group B – Intervention group: Dose 1: 4CMenB at 11–13 years of age Dose 2: 4CMenB at 14–16 years of age Interval: 24–36 months between doses This schedule represents a long-interval dosing strategy designed to test whether giving the two doses several years apart improves antibody persistence. The 4CMenB (Bexsero®) is supplied as a 0.5 mL dose in a pre-filled syringe and administered by intramuscular injection. Vaccines are administered according to the Australian Immunisation Handbook procedures.
Locations(1)
View Full Details on ANZCTR
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ACTRN12625001444471