MedDataX Logo

MenABCWY Noninferiority Study in Healthy Participants ≥10 to <26 Years of Age

NCT ID: NCT04440163

Last Updated: 2023-04-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2431 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-17

Study Completion Date

2022-07-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT04440176

Meningococcal Vaccine
COMPLETED PHASE2

Safety of MenACWY-CRM Vaccination in Adolescents

NCT01452464

Meningococcal Disease
COMPLETED

Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers

NCT03691610

Healthy Volunteers (Meningococcal Infection)
COMPLETED PHASE3

Immunogenicity and Safety Study of GSK's MenABCWY Vaccine in Healthy Adolescents and Adults Previously Primed With MenACWY Vaccine

NCT04707391

Meningitis, Meningococcal
COMPLETED PHASE3

Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US

NCT03537508

Healthy Volunteers (Meningococcal Infection)
COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Meningococcal Vaccine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1-Immuno Subset (ACWY Naive,MenABCWY/Saline)

ACWY Naive subjects, MenABCWY/Saline

Group Type EXPERIMENTAL

MenABCWY

Intervention Type BIOLOGICAL

N meningitidis groups A, B, C, W, and Y vaccine

Saline

Intervention Type BIOLOGICAL

Placebo

2-Immuno Subset (ACWY Naive, Trumenba/MenACWY-CRM)

ACWY Naive subjects, Trumenba/MenACWY-CRM

Group Type EXPERIMENTAL

Trumenba

Intervention Type BIOLOGICAL

Bivalent recombinant lipoprotein 2086 vaccine

MenACWY-CRM

Intervention Type BIOLOGICAL

Meningococcal group A, C, W-135, and Y conjugate vaccine

3-Immuno Subset (ACWY Experienced,MenABCWY/Saline)

ACWY Experienced subjects, MenABCWY/Saline

Group Type EXPERIMENTAL

MenABCWY

Intervention Type BIOLOGICAL

N meningitidis groups A, B, C, W, and Y vaccine

Saline

Intervention Type BIOLOGICAL

Placebo

4-Immuno Subset (ACWY Experienced,Trumenba/MenACWY-CRM)

ACWY Experienced subjects, Trumenba/MenACWY-CRM

Group Type EXPERIMENTAL

Trumenba

Intervention Type BIOLOGICAL

Bivalent recombinant lipoprotein 2086 vaccine

MenACWY-CRM

Intervention Type BIOLOGICAL

Meningococcal group A, C, W-135, and Y conjugate vaccine

5-Safety Subset (ACWY Naive,MenABCWY/Saline)

ACWY Naive subjects, MenABCWY/Saline

Group Type EXPERIMENTAL

MenABCWY

Intervention Type BIOLOGICAL

N meningitidis groups A, B, C, W, and Y vaccine

Saline

Intervention Type BIOLOGICAL

Placebo

6-Safety Subset (ACWY Naive,Trumenba/MenACWY-CRM)

ACWY Naive subjects, Trumenba/MenACWY-CRM

Group Type EXPERIMENTAL

Trumenba

Intervention Type BIOLOGICAL

Bivalent recombinant lipoprotein 2086 vaccine

MenACWY-CRM

Intervention Type BIOLOGICAL

Meningococcal group A, C, W-135, and Y conjugate vaccine

7-Safety Subset (ACWY Experienced,MenABCWY/Saline)

ACWY Experienced subjects, MenABCWY/Saline

Group Type EXPERIMENTAL

MenABCWY

Intervention Type BIOLOGICAL

N meningitidis groups A, B, C, W, and Y vaccine

Saline

Intervention Type BIOLOGICAL

Placebo

8-Safety Subset (ACWY Experienced,Trumenba/MenACWY-CRM)

ACWY Experienced subjects, Trumenba/MenACWY-CRM

Group Type EXPERIMENTAL

Trumenba

Intervention Type BIOLOGICAL

Bivalent recombinant lipoprotein 2086 vaccine

MenACWY-CRM

Intervention Type BIOLOGICAL

Meningococcal group A, C, W-135, and Y conjugate vaccine

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MenABCWY

N meningitidis groups A, B, C, W, and Y vaccine

Intervention Type BIOLOGICAL

Saline

Placebo

Intervention Type BIOLOGICAL

Trumenba

Bivalent recombinant lipoprotein 2086 vaccine

Intervention Type BIOLOGICAL

MenACWY-CRM

Meningococcal group A, C, W-135, and Y conjugate vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Alabama Clinical Therapeutics, LLC, Birmington Pediatric Assocaites

Birmingham, Alabama, United States

Site Status

Central Research Associates, Inc.

Birmingham, Alabama, United States

Site Status

Fiel Family and Sports Medicine, PC/CCT Research

Tempe, Arizona, United States

Site Status

Velocity Clinical Research (Banning)

Banning, California, United States

Site Status

Madera Family Medical Group

Madera, California, United States

Site Status

Center for Clinical Trials, LLC

Paramount, California, United States

Site Status

Center for Clinical Trials

Paramount, California, United States

Site Status

Optumcare Colorado Springs, LLC

Colorado Springs, Colorado, United States

Site Status

ALL Medical Research, LLC

Cooper City, Florida, United States

Site Status

Alliance for MultiSpecialty Research, LLC - Miami

Coral Gables, Florida, United States

Site Status

Health Awareness, Inc.

Jupiter, Florida, United States

Site Status

Altus Research

Lake Worth, Florida, United States

Site Status

Acevedo Clinical Research Associates

Miami, Florida, United States

Site Status

Healthy Life Research, Inc.

Miami, Florida, United States

Site Status

Bio-Medical Research, LLC

Miami, Florida, United States

Site Status

Crystal Biomedical Research, LLC

Miami Lakes, Florida, United States

Site Status

San Marcus Research Clinic, Inc.

Miami Lakes, Florida, United States

Site Status

Complete Health Research

Ormond Beach, Florida, United States

Site Status

Oviedo Medical Research, LLC

Oviedo, Florida, United States

Site Status

PAS Research

Tampa, Florida, United States

Site Status

Tekton Research, Inc.

Chamblee, Georgia, United States

Site Status

Velocity Clinical Research - Boise

Meridian, Idaho, United States

Site Status

Saltzer Health

Nampa, Idaho, United States

Site Status

MOC Research

Mishawaka, Indiana, United States

Site Status

The South Bend Clinic Center for Research

South Bend, Indiana, United States

Site Status

The Iowa Clinic

Ankeny, Iowa, United States

Site Status

The Iowa Clinic

West Des Moines, Iowa, United States

Site Status

Alliance for Multispecialty Research, LLC

El Dorado, Kansas, United States

Site Status

Alliance for Multispecialty Research, LLC

Newton, Kansas, United States

Site Status

Michael W. Simon, MD, PSC

Lexington, Kentucky, United States

Site Status

Meridian Clinical Research, LLC

Baton Rouge, Louisiana, United States

Site Status

Meridian Clinical Research, LLC

Baton Rouge, Louisiana, United States

Site Status

Acorn to Oak Pediatrics - ACC Pediatric Research

Haughton, Louisiana, United States

Site Status

Sundance Clinical Research, LLC

St Louis, Missouri, United States

Site Status

Skyline Medical Center, PC/CCT Research

Elkhorn, Nebraska, United States

Site Status

Quality Clinical Research

Omaha, Nebraska, United States

Site Status

Meridian Clinical Research, LLC

Binghamton, New York, United States

Site Status

PMG Research of Salisbury, LLC

Salisbury, North Carolina, United States

Site Status

PMG Research of Wilmington, LLC

Wilmington, North Carolina, United States

Site Status

Accellacare - Winston-Salem

Winston-Salem, North Carolina, United States

Site Status

PMG Research of Winston-Salem, LLC

Winston-Salem, North Carolina, United States

Site Status

Velocity Clinical Research - Cleveland

Cleveland, Ohio, United States

Site Status

Dayton Clinical Research

Dayton, Ohio, United States

Site Status

Pediatric Associates of Fairfield, Inc.

Fairfield, Ohio, United States

Site Status

Senders Pediatrics

South Euclid, Ohio, United States

Site Status

Lynn Institute of Norman

Norman, Oklahoma, United States

Site Status

Tekton Research

Yukon, Oklahoma, United States

Site Status

Liberty Family Practice

Erie, Pennsylvania, United States

Site Status

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

Accellacare US Inc.

Mt. Pleasant, South Carolina, United States

Site Status

Internal Medicine and Pediatric Associates of Bristol, PC

Bristol, Tennessee, United States

Site Status

Holston Medical Group

Kingsport, Tennessee, United States

Site Status

Family Medicine Associates of Texas

Carrollton, Texas, United States

Site Status

AIM Trials, LLC

Plano, Texas, United States

Site Status

North Texas Family Medicine

Plano, Texas, United States

Site Status

Tekton Research

San Antonio, Texas, United States

Site Status

Olympus Family Medicine/CCT Research

Holladay, Utah, United States

Site Status

Pediatric Care

Provo, Utah, United States

Site Status

J. Lewis Research, Inc. / Foothill Family Clinic

Salt Lake City, Utah, United States

Site Status

J. Lewis Research, Inc. / Foothill Family Clinic South

Salt Lake City, Utah, United States

Site Status

J. Lewis Research, Inc. / Jordan River Family Medicine

South Jordan, Utah, United States

Site Status

SANARE s.r.o

České Budějovice, , Czechia

Site Status

Fakultni nemocnice Hradec Kralove

Hradec Králové, , Czechia

Site Status

Ordinace praktickeho lekare pro deti a dorost

Jindřichův Hradec, , Czechia

Site Status

MUDr. Katerina Stichhauerova s.r.o.

Pardubice, , Czechia

Site Status

Medicentrum 6 s.r.o.

Prague, , Czechia

Site Status

Praktik Pb s.r.o.

Příbram, , Czechia

Site Status

Aarhus Universitetshospital

Aarhus N, , Denmark

Site Status

DRC Gyógyszervizsgáló Központ Kft.

Balatonfüred, , Hungary

Site Status

ClinTrial Audit Kft., Klinikai Farmakologiai Intezet, Vedooltasi Ambulancia

Debrecen, , Hungary

Site Status

Coronella Orvosi Centrum / Trial Pharma Kft.

Gyula, , Hungary

Site Status

CRU Hungary Kft.

Miskolc, , Hungary

Site Status

Fejér Megyei Szent György Egyetemi Oktató Kórház

Székesfehérvár, , Hungary

Site Status

Centrum Badan Klinicznych JCI

Krakow, , Poland

Site Status

Przylądek Zdrowia

Krakow, , Poland

Site Status

Niepubliczny Zaklad Lecznictwa Ambulatoryjnego MICHALKOWICE

Siemianowice Śląskie, , Poland

Site Status

Szpital im. Sw. Jadwigi Slaskiej w Trzebnicy

Trzebnica, , Poland

Site Status

Niepubliczny Zaklad Opieki Zdrowotnej "Salmed"

Łęczna, , Poland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Czechia Denmark Hungary Poland

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

Access external resources that provide additional context or updates about the study.

https://pmiform.com/clinical-trial-info-request?StudyID=C3511001

To obtain contact information for a study center near you, click here.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019-004313-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C3511001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Adolescent MenACWY Booster Study
NCT03694405 COMPLETED PHASE4
Assessing the Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents
NCT02285777 COMPLETED PHASE2
Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents
NCT02140762 COMPLETED PHASE2
Phase 2, Observer-Blind, Placebo-Controlled, Randomized, Multi-Center Extension Study to Evaluate the Safety and Immunogenicity of a Booster Dose of a MenABCWY Vaccine Administered 24 Months Following the Primary Series to Adolescents and Young Adults Who Participated in V102_03 (NCT01272180)
NCT01992536 COMPLETED PHASE2
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants
NCT00474526 COMPLETED PHASE3
Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adolescents
NCT02199691 COMPLETED PHASE2
Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
NCT03673462 COMPLETED PHASE3
Safety and Immunogenicity Evaluation After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants and Toddlers
NCT00667602 COMPLETED PHASE3
Study to Evaluate the Immune Response After a Booster Dose of a Quadrivalent Meningococcal (MenACYW) Conjugate Vaccine When Administered Alone or Concomitantly With a Licensed Meningococcal Serogroup B Vaccine, in Participants Who Received Primary Quadrivalent Meningococcal Conjugate Vaccine (MCV4)
NCT04084769 COMPLETED PHASE3
Safety and Immunogenicity of Intradermal Versus Subcutaneous Doses of Menomune®
NCT00850603 COMPLETED PHASE4
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults
NCT00450437 COMPLETED PHASE3
A Study to Evaluate the Safety and Immunogenicity of 4 Doses of MenACWY Conjugate Vaccine, Administered Concomitantly With Routine Vaccines, Among Infants Aged 2 Months
NCT01000311 COMPLETED PHASE3
Study to Assess the Safety and Immunogenicity of a Single Dose of GlaxoSmithKline's (GSK) Meningococcal MenACWY-CRM Vaccine (Menveo), Administered to Subjects 15 Through 55 Years of Age, Approximately 4-6 Years After Primary ACWY Vaccination
NCT02986854 COMPLETED PHASE3
Safety Surveillance of MenACWY-CRM Vaccine in Children
NCT01452438 COMPLETED
Study on a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared to a Meningococcal Reference Vaccine, and When Given Alone or With Two Other Vaccines in Healthy Adolescents
NCT04490018 COMPLETED PHASE3
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Healthy Adults
NCT00474487 COMPLETED PHASE3
Study on Immunogenicity and Safety of a Meningococcal ACYW Conjugate Vaccine in Healthy Infants and Toddlers
NCT06284915 COMPLETED PHASE3
A Study to Evaluate the Persistence and Immune Response to a Booster Dose of MenACWY
NCT01018732 COMPLETED PHASE2
Study of the Safety and Immune Response of a Meningococcal Conjugate Vaccine Administered to Healthy Adolescents
NCT00262041 COMPLETED PHASE2
Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
NCT05087056 ACTIVE_NOT_RECRUITING PHASE2
A Study on the Safety, Effectiveness and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Adolescents and Adults
NCT04886154 COMPLETED PHASE1/PHASE2
Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Meningococcal ACWY Conjugate Vaccine in Healthy Children 2 Through 10 Years of Age.
NCT01682876 COMPLETED PHASE3
Safety & Immunogenicity of 1 Dose of GSK134612 in Children 12-14 Months and 3-5 Years Old
NCT00196976 COMPLETED PHASE2
Study of a Single Dose of Menactra® Vaccine 4-6 Years After Prior Menactra Vaccine
NCT01442675 COMPLETED PHASE2
Safety, Tolerability and Immunogenicity of a Third Dose of One of Four Different Formulations of rMenB + MenACWY Combination Vaccine in Adolescents Who Previously Received the Same Study Vaccines
NCT01367158 COMPLETED PHASE2