Safety and Immunogenicity of Men B

Safety and immunogenicity of Men B when administered concomitantly with Men ACWY vaccine to healthy subject 16-18 years of age

Protocol Description

Meningitis is caused by the bacteria Neisseria meningitidis. It can attack the brain and spinal cord and cause swelling in those areas as well as a serious infection of the bloodstream, called septicemia. Approximately 10% to 15% of people infected with meningococcal disease will die, sometimes as quickly as 24 hours after symptoms appear. For those who survive, about 1 in 5 may experience a variety of long-term disabilities including hearing loss, brain damage and nervous system problems, kidney damage, loss of limbs, and skin scarring. There have been five common groups of the bacteria that cause meningococcal disease: A, C, W, Y, and B. In the United States, three of these bacterial groups—B, C, and Y—cause most of the meningococcal disease cases.

We routinely administer adolescents and young adults two different approved vaccines for meningitis — one for groups A, C, W, and Y (Menveo or Menactra) and another for group B (Bexsero).

You or your loved one have already been vaccinated for meningitis ACWY (Menveo or Menactra) at age 11 to 12 years (still need booster shot at age 16).

The meningitis B vaccine (Bexsero) is administered at 16 years as part of a 2-dose series.

A combination vaccine of the two standard-of-care, well-established vaccines for meningitis ACWY (Menveo) and meningitis B (Bexsero) has been developed as a single vaccine for meningitis ABCWY, MenABCWY (Menveo+Bexsero). Availability of this combination would reduce the number of injections and could increase coverage for meningococcal disease worldwide.

We are conducting the final trial for FDA approval to assess the immunogenicity and safety of administering MenACWY (Menveo) first, MenB (Bexsero) first or both on the same day (separate injections) in healthy adolescents and young adults, ages 16 through 18 years of age, who previously received one dose of the MenACWY vaccine (Menveo or Menactra).

Eligibility Criteria

WHO can participate?  Adolescent/young adults between the ages of 16 and 18 years of age who received one dose of the MenACWY vaccine (Menveo or Menactra) at least 4 years ago.

WHAT happens? Adolescent/young adults enrolled in the clinical trial will receive a total of 3 injections. A total of 945 adolescents will be randomized, by chance, to 1 of 3 treatment groups at the initial visit.

  • 1 dose of the MenACWY vaccine (Menveo) and 1 dose of placebo (no study product)
  • OR
  • 1 dose of MenB vaccine (Bexsero) and 1 doses of placebo (no study product)
  • OR
  • 1 dose of MenACWY vaccine (Menveo) and 1 dose of MenB vaccine (Bexsero)
  • Given as separate injections – in opposite arms

At the 3rd visit on Day 60, all 3 groups will receive MenB vaccine (Bexsero), and at the 4th visit on Day 90, each of the 3 groups will receive MenB vaccine (Bexsero), MenACWY vaccine (Menveo) or placebo (no study product), respectively.


  • 4-5 in-person study visits (visit 1 [day 1], visit 2 [day 30], visit 3 [day 60], visit 4 [day 90], and visit 5 [day 120].
  • 7 follow-up phone calls (up to day 450)
  • 4 injections (2 at visit 1 [day 1], and 1 at visit 3 [day 60] and visit 4 [day 90])
  • 3 blood draws (one per visit, at visit 1 [day 1], 2 [day 30] and 4 [day 120]
  • Total duration: 15 months from first vaccination
  • Compensation provided

Primary Investigator

Alejandro Hoberman, MD

Contact Information

For additional information or to enroll, please visit Meningitis Combination Vaccine | UPMC Children's or contact 412-692-7382.