Clinical trial NCT04440176: A Trial to Describe the Safety and Immunogenicity of MenABCWY When Administered on 2 Schedules
Official title: A PHASE 2b, RANDOMIZED, OBSERVER-BLINDED TRIAL TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MenABCWY ADMINISTERED ON 2 DIFFERENT DOSING SCHEDULES IN HEALTHY PARTICIPANTS ≥11 TO <15 YEARS OF AGE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Meningococcal Vaccine
Keywords: pentavalent meningococcal vaccine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-06-19
Enrollment: 309
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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 receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
* Receipt of any blood products, including immunoglobulin, within 6 months before the first study vaccination.
* Current use of systemic antibiotics with no foreseeable date of discontinuation prior to anticipated date of enrollment (first vaccination).

Primary outcomes:
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: Percentage of Participants Reporting AEs Within 30 Days After Vaccination 1: 0 and 36 Month Schedule
timeFrame: Within 30 days after vaccination 1 (first dose of MenABCWY)
measure: Percentage of Participants Reporting AEs Within 30 Days After Vaccination 2: 0 and 36 Month Schedule
timeFrame: Within 30 days after vaccination 2 (saline)
measure: Percentage of Participants Reporting AEs Within 30 Days After Vaccination 3: 0 and 36 Month Schedule
timeFrame: Within 30 days after vaccination 3 (second dose of MenABCWY)
measure: Percentage of Participants Reporting Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAEs) and Newly Diagnosed Chronic Medical Condition (NDCMCs) Within 30 Days After Vaccination 1: 0 and 12 Month Schedule
timeFrame: Within 30 days after vaccination 1 (First dose of MenABCWY)
measure: Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 2: 0 and 12 Month Schedule
timeFrame: Within 30 days after vaccination 2 (Second dose of MenABCWY)
measure: Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 1: 0 and 36 Month Schedule
timeFrame: Within 30 days after vaccination 1 (First dose of MenABCWY)
measure: Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 2: 0 and 36 Month Schedule
timeFrame: Within 30 days after vaccination 2 (Saline)
measure: Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 3: 0 and 36 Month Schedule
timeFrame: Within 30 days after vaccination 3 (Second dose of MenABCWY)
measure: Percentage of Participants Reporting AEs Within 30 Days After Any MenABCWY Vaccination: 0 and 12 Month Schedule
timeFrame: Within 30 Days after any MenABCWY vaccination
measure: Percentage of Participants Reporting AEs Within 30 Days After Any MenABCWY Vaccination: 0 and 36 Month Schedule
timeFrame: Within 30 days after any MenABCWY vaccination
measure: Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Any MenABCWY Vaccination: 0 and 12 Month Schedule
timeFrame: Within 30 days after any MenABCWY vaccination
measure: Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Any MenABCWY Vaccination: 0 and 36 Month Schedule
timeFrame: Within 30 days after any MenABCWY vaccination
measure: Percentage of Participants Reporting AEs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 12 Month Schedule
timeFrame: From vaccination 1 through 1 month after vaccination 1 (First dose of MenABCWY)
measure: Percentage of Participants Reporting AEs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 36 Month Schedule
timeFrame: Vaccination 1 through 1 month after vaccination 1 (First dose of MenABCWY)
measure: Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 12 Month Schedule
timeFrame: From vaccination 1 through 1 month after vaccination 1 (First dose of MenABCWY)
measure: Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 36 Month Schedule
timeFrame: From vaccination 1 through 1 month after vaccination 1 (First dose of MenABCWY)
measure: Percentage of Participants Reporting AEs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 12 Month Schedule
timeFrame: From vaccination 2 through 1 month after vaccination 2 (Second dose of MenABCWY)
measure: Percentage of Participants Reporting AEs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 36 Month Schedule
timeFrame: From vaccination 2 through 1 month after vaccination 2 (Saline)
measure: Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 12 Month Schedule
timeFrame: From vaccination 2 through 1 month after vaccination 2 (Second dose of MenABCWY)
measure: Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 36 Month Schedule
timeFrame: From vaccination 2 through 1 month after vaccination 2 (Saline)
measure: Percentage of Participants Reporting AEs From Vaccination 3 Through 1 Month After Vaccination 3: 0 and 36 Month Schedule
timeFrame: From vaccination 3 through 1 month after vaccination 3 (Second dose of MenABCWY)
measure: Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 3 Through 1 Month After Vaccination 3: 0 and 36 Month Schedule
timeFrame: From vaccination 3 through 1 month after vaccination 3 (Second dose of MenABCWY)
measure: Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 1 Through 6 Months After Vaccination 1: 0 and 12 Month Schedule
timeFrame: From 1 month after vaccination 1 through 6 months after vaccination 1 (First dose of MenABCWY)
measure: Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 1 Through 6 Months After Vaccination 1: 0 and 36 Month Schedule
timeFrame: From 1 month after vaccination 1 through 6 months after vaccination 1 (First dose of MenABCWY)
measure: Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 2 Through 6 Months After Vaccination 2: 0 and 12 Month Schedule
timeFrame: From 1 month after vaccination 2 through 6 months after vaccination 2 (Second dose of MenABCWY)
measure: Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 2 Through 6 Months After Vaccination 2: 0 and 36 Month Schedule
timeFrame: From 1 month after vaccination 2 through 6 months after vaccination 2 (Saline)
measure: Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 6 Months After Vaccination 1: 0 and 12 Month Schedule
timeFrame: From vaccination 1 through 6 months after vaccination 1 (First dose of MenABCWY)
measure: Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 6 Months After Vaccination 1: 0 and 36 Month Schedule
timeFrame: From vaccination 1 through 6 months after vaccination 1 (First dose of MenABCWY)
measure: Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 6 Months After Vaccination 2: 0 and 12 Month Schedule
timeFrame: From vaccination 2 through 6 months after vaccination 2 (Second dose of MenABCWY)
measure: Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 6 Months After Vaccination 2: 0 and 36 Month Schedule
timeFrame: From vaccination 2 through 6 months after vaccination 2 (Saline)
measure: Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 1: 0 and 12 Month Schedule
timeFrame: 30 minutes after vaccination 1 (First dose of MenABCWY)
measure: Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 2: 0 and 12 Month Schedule
timeFrame: 30 minutes after vaccination 2 (Second dose of MenABCWY)
measure: Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 1: 0 and 36 Month Schedule
timeFrame: 30 minutes after vaccination 1 (First dose of MenABCWY)
measure: Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 2: 0 and 36 Month Schedule
timeFrame: 30 minutes after vaccination 2 (Saline)
measure: Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 3: 0 and 36 Month Schedule
timeFrame: 30 minutes after vaccination 3 (Second dose of MenABCWY)
measure: Percentage of Participants Who Missed School or Work Because of AEs Within 6 Months After Vaccination 1: 0 and 12 Month Schedule
timeFrame: Within 6 months after vaccination 1 (First dose of MenABCWY)
measure: Percentage of Participants Who Missed School or Work Because of AEs Within 6 Months After Vaccination 1: 0 and 36 Month Schedule
timeFrame: Within 6 months after vaccination 1 (First dose of MenABCWY)
measure: Percentage of Participants Who Missed School or Work Because of AEs Within 6 Months After Vaccination 2: 0 and 12 Month Schedule
timeFrame: Within 6 months after vaccination 2 (Second dose of MenABCWY)
measure: Percentage of Participants Who Missed School or Work Because of AEs Within 6 Months After Vaccination 2: 0 and 36 Month Schedule
timeFrame: Within 6 months after vaccination 2 (Saline)
measure: Percentage of Participants Who Missed School or Work Because of AEs Within 1 Month After Vaccination 3: 0 and 36 Month Schedule
timeFrame: Within 1 month after vaccination 3 (Second dose of MenABCWY)
Secondary outcomes:
measure: Percentage of Participants With hSBA Titer >= LLOQ for Each of the Meningococcal Group A, C, W, and Y (MenACWY) Test Strains at Baseline and 1 Month After the First Dose of MenABCWY: 0 and 12 Month Schedule-Post-Vaccination 1 Evaluable Population
timeFrame: Baseline (before vaccination 1) and 1 month after the first dose of MenABCWY
measure: Percentage of Participants With hSBA Titer >= LLOQ for Each of the MenACWY Test Strains at Baseline and 1 Month After the Second Dose of MenABCWY: 0 and 12 Month Schedule-Post-Vaccination 2 Evaluable Population
timeFrame: Baseline (before vaccination 1) and 1 month after the second dose of MenABCWY
measure: Percentage of Participants With hSBA Titer >=LLOQ for Each of the MenACWY Test Strains at Baseline and 1 Month After First Dose of MenABCWY: 0 and 36 Month Schedule-Post-Vaccination 1 Evaluable Population
timeFrame: Baseline (before vaccination 1) and 1 month after first dose of MenABCWY
measure: Percentage of Participants With hSBA Titer >=LLOQ for Each of the MenACWY Test Strains at Baseline and 1 Month After Second Dose of MenABCWY: 0 and 36 Month Schedule-Post-Vaccination 2 Evaluable Population
timeFrame: Baseline (before vaccination 1) and 1 month after second dose of MenABCWY
measure: Percentage of Participants With hSBA Titer >=LLOQ for Each of the 4 Primary MenB Test Strains at 12 Months and 24 Months After Vaccination 2: 0 and 12 Month Schedule
timeFrame: At 12 months and 24 months after vaccination 2 (Second dose of MenABCWY)
measure: Percentage of Participants With hSBA Titer >=LLOQ for Each ACWY Test Strains at 12 Months and 24 Months After Vaccination 2: 0 and 12 Month Schedule
timeFrame: At 12 months and 24 months after vaccination 2 (Second dose of MenABCWY)
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Alabama
city: San Diego
country: United States
facility: California Research Foundation
state: California
city: Orlando
country: United States
facility: Nona Pediatric Center
state: Florida
city: Norfolk
country: United States
facility: Velocity Clinical Research, Norfolk
state: Nebraska
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Dayton
country: United States
facility: Ohio Pediatric Research Association Inc.
state: Ohio
city: North Charleston
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Fort Worth
country: United States
facility: Benchmark Research
state: Texas
city: Fort Worth
country: United States
facility: Texas Health Resources
state: Texas
city: San Antonio
country: United States
facility: Diagnostics Research Group
state: Texas
city: Kaysville
country: United States
facility: Wee Care Pediatrics
state: Utah
city: Murray
country: United States
facility: Wasatch Pediatrics, Cottonwood Office
state: Utah
city: Orem
country: United States
facility: Utah Valley Pediatrics - Timpanogos Office
state: Utah
city: Roy
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. / Foothill Family Clinic
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. / Foothill Family Clinic South
state: Utah
city: South Jordan
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Utah
city: Syracuse
country: United States
facility: Wee Care Pediatrics
state: Utah
city: Charlottesville
country: United States
facility: Pediatric Research of Charlottesville, LLC
state: Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: