NCT00728260

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
1,421

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
2.9 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2008

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 5, 2008

Completed
4.7 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
1.8 years until next milestone

Results Posted

Study results publicly available

February 12, 2015

Completed
Last Updated

February 12, 2015

Status Verified

February 1, 2015

Enrollment Period

7.8 years

First QC Date

May 7, 2008

Results QC Date

January 7, 2015

Last Update Submit

February 10, 2015

Conditions

MeningitisMeningococcal Disease

Keywords

MeningitisMeningococcal diseaseMenactra vaccine

Outcome Measures

Primary Outcomes (2)

  • Summary of Diagnoses With Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level.

    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 comparison window. Clinical setting is given in parenthesis as (H) for hospital.

    Day 0 up to Day 30 post-vaccination

  • Summary of Diagnoses With Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level.

    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 comparison window. Clinical setting is given in parenthesis as (H) for hospital.

    Day 31 up to Day 180 post-vaccination

Other Outcomes (1)

  • Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database - All Ages Combined

    Day 0 up to 6 months post-vaccination

Study Arms (1)

Menactra Vaccine Recipients

Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They 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. Six-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31-180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses. Menactra vaccine was administered according to routine clinical practice.

Biological: None administered in this study

Interventions

None administered in this studyBIOLOGICAL

N/A in this study

Menactra 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, Eaton A, Baxter R, Robertson CA, Decker MD, Greenberg DP, Bassily E, Klein NP. Post-licensure safety surveillance study of routine use of quadrivalent meningococcal diphtheria toxoid conjugate vaccine (MenACWY-D) in infants and children. Vaccine. 2018 Apr 12;36(16):2133-2138. doi: 10.1016/j.vaccine.2018.02.107. Epub 2018 Mar 14.

    PMID: 29550195DERIVED

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

May 7, 2008

First Posted

August 5, 2008

Study Start

July 1, 2005

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

February 12, 2015

Results First Posted

February 12, 2015

Record last verified: 2015-02

Locations

US(1)