Clinical trial NCT04440163: MenABCWY Noninferiority Study in Healthy Participants ≥10 to <26 Years of Age
Official title: A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, OBSERVER-BLINDED TRIAL TO ASSESS THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MenABCWY IN HEALTHY PARTICIPANTS ≥10 TO <26 YEARS OF AGE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningococcal Vaccine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-06-19
Enrollment: 2431
Sex: ALL
Minimum age (years): 10
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to determine the immunologic noninferiority of MenABCWY to licensed vaccines Trumenba and MenACWY-CRM (Menveo) by assessing the safety and immunogenicity of MenABCWY and the comparators in both ACWY-naïve and ACWY-experienced healthy participants ≥10 to \<26 years of age.


Eligibility criteria: Inclusion Criteria:

* Male or female subject aged \>=10 and \<26 years at the time of randomization.
* Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
* Negative urine pregnancy test for all female subjects.
* ACWY-naïve participants: Participants who have never received a prior dose of a meningococcal vaccine containing ACWY serogroups.
* ACWY-experienced participants: Participants who have received not more than 1 prior dose, no sooner than 4 years prior to the date of randomization of Menactra or Menveo.

Exclusion Criteria:

* Previous vaccination with any meningococcal group B vaccine, any purely polysaccharide (nonconjugate) meningococcal vaccine, or monovalent/bivalent meningococcal vaccine.- Subjects receiving any allergen immunotherapy with a non-licensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
* A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects in the United States with terminal complement deficiency are excluded from participation in this study.
* Significant neurological disorder or history of seizure (excluding simple febrile seizure).
* Current chronic use of systemic antibiotics.
* Participation in other studies involving investigational drug(s) or investigational vaccine(s) within 28 days prior to study entry and/or during study participation.
* Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
* History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
* Receipt of any blood products, including immunoglobulin, within 6 months before the first study vaccination.

Primary outcomes:
measure: Percentage of Participants Achieving At Least 4-Fold Rise in Serum Bactericidal Assay Using Human Complement (hSBA) Titer From Baseline for Each MenACWY Strains: 1 Month After Vaccination 2 in Group 1 Compared to 1 Month After Vaccination 1 in Group 2
timeFrame: Baseline (pre-vaccination on Day 1), 1 month after Vaccination 2 in Group 1 and 1 month after Vaccination 1 in Group 2
measure: Percentage of Participants Achieving At Least 4-Fold Rise in hSBA Titer From Baseline for Each of the MenACWY Strains: 1 Month After Vaccination 2 in Group 3 Compared to 1 Month After Vaccination 1 in Group 4
timeFrame: Baseline (pre-vaccination on Day 1), 1 month after Vaccination 2 in Group 3 and 1 month after Vaccination 1 in Group 4
measure: Percentage of Participants Achieving hSBA Titer Greater Than or Equal to (>=) LLOQ for All Primary Neisseria Meningitidis Group B (MenB) Test Strains Combined (Composite Response): Groups 1 and 3 Combined Versus Groups 2 and 4 Combined
timeFrame: 1 month after Vaccination 2
measure: Percentage of Participants Achieving At Least a 4-Fold Rise in hSBA Titer From Baseline For Each Primary MenB Test Strains at 1 Month After Vaccination 2: Groups 1 and 3 Combined Versus Groups 2 and 4 Combined
timeFrame: Baseline (pre-vaccination on Day 1), 1 month after Vaccination 2
measure: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
timeFrame: Within 7 days after Vaccination 1
measure: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
timeFrame: Within 7 days after Vaccination 2
measure: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
timeFrame: Within 7 days after Vaccination 1
measure: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
timeFrame: Within 7 days after Vaccination 2
measure: Percentage of Participants With Use of Antipyretic Medication Within 7 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
timeFrame: Within 7 days after Vaccination 1
measure: Percentage of Participants With Use of Antipyretic Medication Within 7 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
timeFrame: Within 7 days after Vaccination 2
measure: Percentage of Participants With Adverse Events (AEs) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
timeFrame: Within 30 days after Vaccination 1
measure: Percentage of Participants With AEs Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
timeFrame: Within 30 days after Vaccination 2
measure: Percentage of Participants With AEs Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
timeFrame: Within 30 days after any vaccination
measure: Percentage of Participants With AEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
timeFrame: From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)
measure: Percentage of Participants With Serious Adverse Events (SAEs) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
timeFrame: Within 30 days after Vaccination 1
measure: Percentage of Participants With SAEs Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
timeFrame: Within 30 days after Vaccination 2
measure: Percentage of Participants With SAEs Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
timeFrame: Within 30 days after any vaccination
measure: Percentage of Participants With SAEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
timeFrame: From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)
measure: Percentage of Participants With SAEs During Follow-up Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
timeFrame: From 1 month after Vaccination 2 up to 6 months after Vaccination 2 (approximately 5 months)
measure: Percentage of Participants With SAEs Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
timeFrame: From day of Vaccination 1 (Day 1) up to 6 months after Vaccination 2 (approximately 12 months)
measure: Percentage of Participants With Medically Attended Adverse Events (MAEs) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
timeFrame: Within 30 days after Vaccination 1
measure: Percentage of Participants With MAEs Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
timeFrame: Within 30 days after Vaccination 2
measure: Percentage of Participants With MAEs Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
timeFrame: Within 30 days after any vaccination
measure: Percentage of Participants With MAEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
timeFrame: From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)
measure: Percentage of Participants With MAEs During Follow-up Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
timeFrame: From 1 month after Vaccination 2 up to 6 months after Vaccination 2 (approximately 5 months)
measure: Percentage of Participants With MAEs Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
timeFrame: From day of Vaccination 1 (Day 1) up to 6 months after Vaccination 2 (approximately 12 months)
measure: Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
timeFrame: Within 30 days after Vaccination 1
measure: Percentage of Participants With NDCMC Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
timeFrame: Within 30 days after Vaccination 2
measure: Percentage of Participants With NDCMC Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
timeFrame: Within 30 Days after any vaccination
measure: Percentage of Participants With NDCMC During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
timeFrame: From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)
measure: Percentage of Participants With NDCMC During Follow-up Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
timeFrame: From 1 month after Vaccination 2 up to 6 months after Vaccination 2 (approximately 5 months)
measure: Percentage of Participants With NDCMC Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
timeFrame: From day of Vaccination 1 (Day 1) up to 6 months after Vaccination 2 (approximately 12 months)
measure: Percentage of Participants With Immediate AE Within 30 Minutes After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
timeFrame: Within 30 minutes after Vaccination 1
measure: Percentage of Participants With Immediate AE Within 30 Minutes After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
timeFrame: Within 30 minutes after Vaccination 2
measure: Percentage of Participants Who Missed Days of School or Work Due to AEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
timeFrame: From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)
Secondary outcomes:
measure: Percentage of Participants Achieving At Least 4-Fold Rise in hSBA Titer From Baseline for Each MenACWY Test Strains: 1 Month After Vaccination 1 in Group 1 Compared to Group 2
timeFrame: Baseline (pre-vaccination on Day 1), 1 month after Vaccination 1
measure: Percentage of Participants Achieving At Least 4-Fold Rise in hSBA Titer From Baseline for Each MenACWY Test Strains: 1 Month After Vaccination 1 in Group 3 Compared to Group 4
timeFrame: Baseline (pre-vaccination on Day 1), 1 month after Vaccination 1
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics, LLC, Birmington Pediatric Assocaites
state: Alabama
city: Birmingham
country: United States
facility: Central Research Associates, Inc.
state: Alabama
city: Tempe
country: United States
facility: Fiel Family and Sports Medicine, PC/CCT Research
state: Arizona
city: Banning
country: United States
facility: Velocity Clinical Research (Banning)
state: California
city: Madera
country: United States
facility: Madera Family Medical Group
state: California
city: Paramount
country: United States
facility: Center for Clinical Trials, LLC
state: California
city: Paramount
country: United States
facility: Center for Clinical Trials
state: California
city: Colorado Springs
country: United States
facility: Optumcare Colorado Springs, LLC
state: Colorado
city: Cooper City
country: United States
facility: ALL Medical Research, LLC
state: Florida
city: Coral Gables
country: United States
facility: Alliance for MultiSpecialty Research, LLC - Miami
state: Florida
city: Jupiter
country: United States
facility: Health Awareness, Inc.
state: Florida
city: Lake Worth
country: United States
facility: Altus Research
state: Florida
city: Miami Lakes
country: United States
facility: Crystal Biomedical Research, LLC
state: Florida
city: Miami Lakes
country: United States
facility: San Marcus Research Clinic, Inc.
state: Florida
city: Miami
country: United States
facility: Acevedo Clinical Research Associates
state: Florida
city: Miami
country: United States
facility: Healthy Life Research, Inc.
state: Florida
city: Miami
country: United States
facility: Bio-Medical Research, LLC
state: Florida
city: Ormond Beach
country: United States
facility: Complete Health Research
state: Florida
city: Oviedo
country: United States
facility: Oviedo Medical Research, LLC
state: Florida
city: Tampa
country: United States
facility: PAS Research
state: Florida
city: Chamblee
country: United States
facility: Tekton Research, Inc.
state: Georgia
city: Meridian
country: United States
facility: Velocity Clinical Research - Boise
state: Idaho
city: Nampa
country: United States
facility: Saltzer Health
state: Idaho
city: Mishawaka
country: United States
facility: MOC Research
state: Indiana
city: South Bend
country: United States
facility: The South Bend Clinic Center for Research
state: Indiana
city: Ankeny
country: United States
facility: The Iowa Clinic
state: Iowa
city: West Des Moines
country: United States
facility: The Iowa Clinic
state: Iowa
city: El Dorado
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kansas
city: Newton
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kansas
city: Lexington
country: United States
facility: Michael W. Simon, MD, PSC
state: Kentucky
city: Baton Rouge
country: United States
facility: Meridian Clinical Research, LLC
state: Louisiana
city: Baton Rouge
country: United States
facility: Meridian Clinical Research, LLC
state: Louisiana
city: Haughton
country: United States
facility: Acorn to Oak Pediatrics - ACC Pediatric Research
state: Louisiana
city: Saint Louis
country: United States
facility: Sundance Clinical Research, LLC
state: Missouri
city: Elkhorn
country: United States
facility: Skyline Medical Center, PC/CCT Research
state: Nebraska
city: Omaha
country: United States
facility: Quality Clinical Research
state: Nebraska
city: Binghamton
country: United States
facility: Meridian Clinical Research, LLC
state: New York
city: Salisbury
country: United States
facility: PMG Research of Salisbury, LLC
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: Accellacare - Winston-Salem
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem, LLC
state: North Carolina
city: Cleveland
country: United States
facility: Velocity Clinical Research - Cleveland
state: Ohio
city: Dayton
country: United States
facility: Dayton Clinical Research
state: Ohio
city: Fairfield
country: United States
facility: Pediatric Associates of Fairfield, Inc.
state: Ohio
city: South Euclid
country: United States
facility: Senders Pediatrics
state: Ohio
city: Norman
country: United States
facility: Lynn Institute of Norman
state: Oklahoma
city: Yukon
country: United States
facility: Tekton Research
state: Oklahoma
city: Erie
country: United States
facility: Liberty Family Practice
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: Accellacare US Inc.
state: South Carolina
city: Bristol
country: United States
facility: Internal Medicine and Pediatric Associates of Bristol, PC
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Carrollton
country: United States
facility: Family Medicine Associates of Texas
state: Texas
city: Plano
country: United States
facility: AIM Trials, LLC
state: Texas
city: Plano
country: United States
facility: North Texas Family Medicine
state: Texas
city: San Antonio
country: United States
facility: Tekton Research
state: Texas
city: Holladay
country: United States
facility: Olympus Family Medicine/CCT Research
state: Utah
city: Provo
country: United States
facility: Pediatric Care
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: J. Lewis Research, Inc. / Jordan River Family Medicine
state: Utah
city: Ceske Budejovice
country: Czechia
facility: SANARE s.r.o
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Jindrichuv Hradec
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Pardubice
country: Czechia
facility: MUDr. Katerina Stichhauerova s.r.o.
city: Praha 6
country: Czechia
facility: Medicentrum 6 s.r.o.
city: Pribram
country: Czechia
facility: Praktik Pb s.r.o.
city: Aarhus N
country: Denmark
facility: Aarhus Universitetshospital
city: Balatonfüred
country: Hungary
facility: DRC Gyógyszervizsgáló Központ Kft.
city: Debrecen
country: Hungary
facility: ClinTrial Audit Kft., Klinikai Farmakologiai Intezet, Vedooltasi Ambulancia
city: Gyula
country: Hungary
facility: Coronella Orvosi Centrum / Trial Pharma Kft.
city: Miskolc
country: Hungary
facility: CRU Hungary Kft.
city: Székesfehérvár
country: Hungary
facility: Fejér Megyei Szent György Egyetemi Oktató Kórház
city: Krakow
country: Poland
facility: Centrum Badan Klinicznych JCI
city: Krakow
country: Poland
facility: Przylądek Zdrowia
city: Leczna
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej "Salmed"
city: Siemianowice Slaskie
country: Poland
facility: Niepubliczny Zaklad Lecznictwa Ambulatoryjnego MICHALKOWICE
city: Trzebnica
country: Poland
facility: Szpital im. Sw. Jadwigi Slaskiej w Trzebnicy
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: