NCT02500511

Brief Summary

To determine the persistence of protective antibody levels for subjects who seroconverted after vaccination with NmVac4-A/C/Y/W-135-DT™ Participants in trial # JN-NM-002, who seroconverted for serogroups A and C will be contacted and asked to provide a blood sample at 12-24 months after vaccination with NmVac4-A/C/Y/W-135-DT. Serum Bactericidal Assays will be performed to evaluated duration of protective antibody titer for NmVac4-A/C/Y/W-135-DT for all four serogroups. To determine if subjects who seroconverted with lower titers retain protective levels of antibody (titer ≥:8) at 12-24 months after vaccination.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 14, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2015

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

April 12, 2016

Status Verified

July 1, 2015

Enrollment Period

2 months

First QC Date

July 14, 2015

Last Update Submit

April 8, 2016

Conditions

Meningococcal MeningitisMeningococcal Infections

Outcome Measures

Primary Outcomes (1)

  • Antibody titer

    12-24 months after vaccination in study JN-NM-002

Interventions

NmVac4-A/C/Y/W-135-DT™BIOLOGICAL

no intervention in this study, received test vaccine in trial JN-NM-002

Also known as: meningococcal meningitis conjugate vaccine quadrivalent

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Subjects who seroconverted for serogroups A and C after vaccination with NmVac4-A/C/Y/W-135-DT in study JN-NM-001

You may qualify if:

  • Willing and able to give informed consent
  • Participant in trial JN-NM-002
  • Seroconverted in trial JN-NM-002 for both serogroups A and C

You may not qualify if:

  • Chronic medication use or medical history that, in the opinion of the Investigator, may impact the quality of the sample or safety of the subject

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRC Clinics

Towson, Maryland, 21204, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples used for antibody assays.

MeSH Terms

Conditions

Meningitis, MeningococcalMeningococcal Infections

Condition Hierarchy (Ancestors)

Meningitis, BacterialCentral Nervous System Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsNeisseriaceae InfectionsGram-Negative Bacterial InfectionsCentral Nervous System InfectionsCentral Nervous System DiseasesNervous System DiseasesMeningitisNeuroinflammatory Diseases

Study Officials

  • Alberto Yataco, MD

    IRC Clinics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2015

First Posted

July 16, 2015

Study Start

June 1, 2015

Primary Completion

August 1, 2015

Study Completion

September 1, 2015

Last Updated

April 12, 2016

Record last verified: 2015-07

Locations

US(1)