Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adults 56 Years and Older

ClinicalTrials.gov ID: NCT02842866

Public ClinicalTrials.gov record NCT02842866. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adults Age 56 Years and Older

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The aim of the study was to demonstrate non-inferiority of immunogenicity and evaluate the safety of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid conjugate vaccine (MenACYW conjugate vaccine) compared to a single dose of Meningococcal Polysaccharide Vaccine Serogroups A, C, Y, and W-135 Combined (Menomune® - A/C/Y/W-135) in adults 56 years of age and older in the United States. Primary objective: -To demonstrate the non-inferiority of the vaccine seroresponse to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW conjugate vaccine compared to those observed following the administration of a single dose of Menomune® - A/C/Y/W-135. Secondary objective: -To compare the serum bactericidal assay using human complement (hSBA) antibody geometric mean titers of meningococcal serogroups A, C, Y, and W following the administration of MenACYW conjugate vaccine to those observed following the administration of Menomune® - A/C/Y/W-135. Observational objectives: * To describe antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA at baseline (before vaccination) and 30 days after vaccination with MenACYW conjugate vaccine or Menomune® - A/C/Y/W-135 in a subset of 100 participants per treatment group. * To describe the safety profile of MenACYW conjugate vaccine compared to that of the licensed Menomune® - A/C/Y/W-135 after a single administration.

Study identification

NCT ID: NCT02842866
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Sanofi Pasteur, a Sanofi Company; Industry
Enrollment: 907 participants

Conditions and interventions

Conditions

Interventions

Biological

Eligibility (public fields only)

Age range: 56 Years and older
Sex: All
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jul 15, 2016 (Actual)
Primary completion: Feb 13, 2017 (Actual)
Completion: Feb 13, 2017 (Actual)
Last update posted: Apr 5, 2022

2016 – 2017

United States locations

U.S. sites: 35
U.S. states: 19
U.S. cities: 31

Facility	City	State	ZIP	Site status
Not listed	Chandler	Arizona	85224	—
Not listed	Anaheim	California	92801	—
Not listed	San Diego	California	92103	—
Not listed	Waterbury	Connecticut	06708	—
Not listed	Clearwater	Florida	33756	—
Not listed	DeLand	Florida	32720	—
Not listed	Jacksonville	Florida	32205	—
Not listed	Jacksonville	Florida	32216	—
Not listed	Ponte Vedra	Florida	32081	—
Not listed	Port Orange	Florida	32127	—
Not listed	West Palm Beach	Florida	33409	—
Not listed	Lenexa	Kansas	66219	—
Not listed	Newton	Kansas	67114	—
Not listed	Wichita	Kansas	67205	—
Not listed	Elkridge	Maryland	21075	—
Not listed	Quincy	Massachusetts	02169	—
Not listed	Troy	Michigan	48098	—
Not listed	St Louis	Missouri	63141	—
Not listed	Endwell	New York	13760	—
Not listed	Greensboro	North Carolina	27408	—
Not listed	Raleigh	North Carolina	27612	—
Not listed	Winston-Salem	North Carolina	27103	—
Not listed	Fargo	North Dakota	58104	—
Not listed	Cincinnati	Ohio	45236	—
Not listed	Cincinnati	Ohio	45246	—
Not listed	Grants Pass	Oregon	97527	—
Not listed	Allentown	Pennsylvania	18012	—
Not listed	Uniontown	Pennsylvania	15401	—
Not listed	Mt. Pleasant	South Carolina	29464	—
Not listed	Mt. Pleasant	South Carolina	29646	—
Not listed	Dallas	Texas	75231	—
Not listed	Dallas	Texas	75234	—
Not listed	South Jordan	Utah	84095	—
Not listed	West Jordan	Utah	84088	—
Not listed	Charlottesville	Virginia	22911	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT02842866, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Apr 5, 2022 · Synced Nov 7, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02842866 live on ClinicalTrials.gov.

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