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 range11 Years – 14 Years

SexALL

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…

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

Timeframe: Within 30 days after vaccination 2 (second dose of MenABCWY)

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 range11 Years – 14 Years

SexALL

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

Timeframe: Within 30 days after vaccination 2 (second dose of MenABCWY)