MenABCWY Vaccine for Meningococcal Disease Prevention

Recruiting in Palo Alto (17 mi)

+23 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Pfizer

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests a vaccine for meningitis in adolescents. The vaccine helps the body build defenses against five types of bacteria that cause meningitis.

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

This trial is for healthy boys and girls aged 11 to less than 15 who haven't had a meningococcal vaccine before. They must be available for the whole study, reachable by phone, and not pregnant. They can't join if they have bleeding issues, unstable allergies, are on certain immune system drugs or antibiotics, have had meningitis or similar diseases, neurological disorders or seizures (except simple febrile seizure), received blood products recently, had severe reactions to vaccines before, or have autoimmune conditions.

Inclusion Criteria

I have never received a meningococcal vaccine.

I am between 11 and 14 years old.

I am available for the study duration and can be contacted by phone.

Exclusion Criteria

I have a condition or take medication that weakens my immune system.

I am not on long-term antibiotics.

I have had an infection caused by Neisseria bacteria.

Treatment Details

Interventions

• MenABCWY (Vaccine)
• Saline (Other)

Trial Overview The trial tests two schedules of the MenABCWY vaccine against meningitis: one group gets two doses with a gap of either 12 months or another with a gap of 36 months. The safety and body's defense response right after vaccination and up to 24 months later are being studied.

Participant Groups

Group I: Group 2 (MenABCWY 0-, 36-months) Experimental Treatment 2 Interventions

MenABCWY administered at Month 0 and Month 36

Group II: Group 1 (MenABCWY 0-, 12-months) Experimental Treatment 1 Intervention

MenABCWY administered at Month 0 and Month 12

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University