Post-licensure Safety Surveillance Study of Menactra Vaccine When Administered As a 2-dose Schedule to Children

NCT01689155 | Completed Results

• 2 other identifiers: MTA57U 1111-1120-1574
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

This is a passive-surveillance study that will accrue subjects for surveillance. For each accrued subject, surveillance for outcomes will continue for six months following the first dose. If a second dose is given within that time, then surveillance will be continued for six months following the second dose. Observational Objective:

• To describe and characterize adverse events occurring after vaccination with Menactra vaccine.

Conditions

Meningitis; Meningococcal Infection

Keywords

Meningitis; Meningococcal Infection; Menactra®

Outcome Measures

Primary Outcomes (1)

• Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database.

  Incidence rates for each event were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison widow. The risk window was Days 0-30 following vaccination; the control window was Days 31-75 post-vaccination.

  Day 0 up to Day 75 post-vaccination

Other Outcomes (2)

• Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Hospital Database.

  Day 0 up to Day 75 post-vaccination

• Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Clinic Database.

  Day 0 up to Day 75 post-vaccination

Study Arms (1)

Study Group

Participants must have received Menactra Vaccine according to routine clinical practice.

Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

Interventions

Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate BIOLOGICAL

0.5 mL, Intramuscular

Also known as: Menactra®

Study Group

Eligibility Criteria

• Age: 9 Months - 23 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Participants at age 9 to 23 months at the time of receipt of the first dose of Menactra vaccine according to routine clinical practice during the study period.

You may qualify if:

• Age 9 to 23 months at the time of receipt of the first dose of Menactra vaccine during the study period.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

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: 29550195 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Meningitis; Meningococcal Infections

Interventions

Meningococcal Vaccines

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

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
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2012
• First Posted: September 21, 2012
• Study Start: June 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: April 1, 2016
• Last Updated: November 11, 2016
• Results First Posted: November 11, 2016

Record last verified: 2016-09

Locations

US (1)