CompletedPhase 2

A Trial to Describe the Safety and Immunogenicity of MenABCWY When Administered on 2 Schedules

United States309 participantsStarted 2020-06-17

Plain-language summary

This study is designed to describe the short-term immunogenicity and safety of 2 doses of Neisseria meningitidis group A, B, C, W, and Y vaccine (MenABCWY) separated by either 12 or 36 months during adolescence, and immunopersistence up to 24 months after completing 2 doses separated by a 12-month interval.

Who can participate

Age range

11 Years – 14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female participants 11 through \<15 years of age at the time of randomization. * Participants who have never received a prior dose of any meningococcal vaccine. Written confirmation of vaccination history must be obtained prior to randomization. * Available for the entire study period and can be reached by telephone. * Healthy participant as determined by medical history, physical examination, and judgement of the investigator. * Negative urine pregnancy test for all female participants; pregnancy test is not applicable to male participants. Exclusion Criteria: * A previous anaphylactic reaction to any vaccine or vaccine-related component. * Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection. * A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as participants with congenital or acquired defects in B-cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. * History of microbiologically proven disease caused by Neisseria meningitidis or Neisseria gonorrhoeae. * Significant neurological disorder or history of seizure (excluding simple febrile seizure). * Any neuroinflammatory or autoimmune condition, including, but no limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis. * Participants receivin…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >=Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Neisseria Meningitidis Serogroup B (MenB) Test Strains at Baseline: 0 and 12 Month Schedule

Timeframe: Baseline (before vaccination 1)

Percentage of Participants With hSBA Titer >=LLOQ for Each of the 4 Primary MenB Test Strains at 1 Month After Vaccination 2: 0 and 12 Month Schedule

Timeframe: 1 month after vaccination 2 (second dose of MenABCWY)

Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MenB Test Strains at Baseline: 0 and 36 Month Schedule

Timeframe: Baseline (before vaccination 1)

Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MenB Test Strains at 1 Month After Vaccination 3: 0 and 36 Month Schedule

Timeframe: 1 Month After Vaccination 3 (second dose of MenABCWY)

Percentage of Participants Reporting Adverse Events (AEs) Within 30 Days After Vaccination 1: 0 and 12 Month Schedule

Timeframe: Within 30 days after vaccination 1 (first dose of MenABCWY)

Percentage of Participants Reporting AEs Within 30 Days After Vaccination 2: 0 and 12 Month Schedule

Trial details

NCT IDNCT04440176

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-01-05

Results submitted2024-12-17

View on ClinicalTrials.gov More Meningococcal Vaccine trials

Plain-language summary

Who can participate

Age range

11 Years – 14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Timeframe: Baseline (before vaccination 1)

Percentage of Participants With hSBA Titer >=LLOQ for Each of the 4 Primary MenB Test Strains at 1 Month After Vaccination 2: 0 and 12 Month Schedule

Timeframe: 1 month after vaccination 2 (second dose of MenABCWY)

Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MenB Test Strains at Baseline: 0 and 36 Month Schedule

Timeframe: Baseline (before vaccination 1)

Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MenB Test Strains at 1 Month After Vaccination 3: 0 and 36 Month Schedule

Timeframe: 1 Month After Vaccination 3 (second dose of MenABCWY)

Percentage of Participants Reporting Adverse Events (AEs) Within 30 Days After Vaccination 1: 0 and 12 Month Schedule

Timeframe: Within 30 days after vaccination 1 (first dose of MenABCWY)

Percentage of Participants Reporting AEs Within 30 Days After Vaccination 2: 0 and 12 Month Schedule