NCT00254995

Brief Summary

To further characterize the safety profile of Menactra vaccine and to identify any signals of potentially vaccine-related adverse events (AEs) not detected during pre-licensure studies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62,626

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2005

Longer than P75 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

July 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2005

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

November 11, 2014

Completed
Last Updated

April 19, 2016

Status Verified

April 1, 2016

Enrollment Period

7.8 years

First QC Date

November 15, 2005

Results QC Date

September 4, 2014

Last Update Submit

April 15, 2016

Conditions

MeningitisMeningococcal Disease

Keywords

MeningitisMeningococcal diseaseMenactra vaccine

Outcome Measures

Primary Outcomes (1)

  • Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons: All Ages Combined - Short-Term Passive Surveillance

    Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each 30-day comparison window. Individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination. Clinical setting is given in parenthesis as either (H) for hospital or (ER) for emergency room.

    Day 0 up to Day 60 post-vaccination

Other Outcomes (8)

  • Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - All Ages Combined - Long-Term Passive Surveillance

    Day 0 up to Day 180 post-vaccination

  • Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons - By Age Categories - Short-Term Passive Surveillance

    Day 0 up to Day 60 post-vaccination

  • Summary of Diagnoses With Significantly Elevated Findings for Menactra Vaccine Recipients vs. Age-Matched Controls - By Age Categories - Long-Term Passive Surveillance

    Day 0 up to Day 180 post-vaccination

  • +5 more other outcomes

Study Arms (2)

Menactra Vaccine Recipients

Participants who received Menactra vaccine as part of routine medical care during the study period in Kaiser Permanente.

Biological: None administered in this study

Age-Matched Control

Each individual receiving Menactra vaccine served as their own control for evaluation of acute (Days 0-30) events (short-term surveillance). For the 6-month (long-term) surveillance, for each person receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a received tetanus and diphtheria toxoids (Td), hepatitis A, hepatitis B, or hepatitis A/hepatitis B combination vaccine as part of routine medical care during the same month 1 year earlier in Kaiser Permanente

Biological: None administered in this study

Interventions

None administered in this studyBIOLOGICAL

N/A in this study

Age-Matched ControlMenactra Vaccine Recipients

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Past receipt of Menactra vaccine

You may qualify if:

  • Receipt of Menactra vaccine during the study period.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Oakland, California, 94612, United States

Location

Related Publications (1)

  • Hansen J, Zhang L, Klein NP, Robertson CA, Decker MD, Greenberg DP, Bassily E, Baxter R. Post-licensure safety surveillance study of routine use of quadrivalent meningococcal diphtheria toxoid conjugate vaccine. Vaccine. 2017 Dec 14;35(49 Pt B):6879-6884. doi: 10.1016/j.vaccine.2017.09.032. Epub 2017 Sep 21.

    PMID: 28941623DERIVED

Related Links

MeSH Terms

Conditions

MeningitisMeningococcal Infections

Condition Hierarchy (Ancestors)

Neuroinflammatory DiseasesNervous System DiseasesNeisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Results Point of Contact

Title
Medical Drector
Organization
Sanofi Pasteur Inc
RegistryContactus@sanofipasteur.com

Study Officials

  • Medical Director

    Sanofi Pasteur Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2005

First Posted

November 17, 2005

Study Start

July 1, 2005

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

April 19, 2016

Results First Posted

November 11, 2014

Record last verified: 2016-04

Locations

US(1)