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

• ClinicalTrials.gov Identifier: NCT01689155
• Recruitment Status: Completed
• First Posted: September 21, 2012
• Results First Posted: November 11, 2016
• Last Update Posted: November 11, 2016
• Sponsor: Sanofi Pasteur, a Sanofi Company
• Information provided by (Responsible Party): Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description

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.

Condition or disease	Intervention/treatment
Meningitis; Meningococcal Infection	Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

Detailed Description:

The study will be carried out in collaboration with the Kaiser Permanente Medical Care Program (KPMCP) under the direction of the Kaiser Permanente Vaccine Study Center (KPVSC). KPMCP is a closed-panel healthcare organization that maintains comprehensive encounter databases that capture all medical care received by enrollees.

Vaccination will be according to routine clinical practice. Vaccination databases will be reviewed to identify eligible persons receiving Menactra vaccine within the KPMCP system.

Study Design

• Study Type: Observational
• Actual Enrollment: 116 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Post-licensure Safety Surveillance Study of Menactra® Vaccine When Administered As a 2-dose Schedule to Children 9 Months Through 23 Months of Age.
• Study Start Date: June 2011
• Actual Primary Completion Date: June 2015
• Actual Study Completion Date: April 2016

Groups and Cohorts

Group/Cohort	Intervention/treatment
Study Group; Participants must have received Menactra Vaccine according to routine clinical practice.	Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate; 0.5 mL, Intramuscular; Other Name: Menactra®

Outcome Measures

Primary Outcome Measures :

1. Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database. [ Time Frame: Day 0 up to Day 75 post-vaccination ]
   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.

Other Outcome Measures:

1. Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Hospital Database. [ Time Frame: Day 0 up to Day 75 post-vaccination ]
   Incidence rates for identified events were to be 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. Note: No events were identified in the hospital database.
2. Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Clinic Database. [ Time Frame: Day 0 up to Day 75 post-vaccination ]
   Incidence rates for pre-specified events were to be 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. Pre-specified neurological conditions, hypersensitivity reactions, and new-onset autoimmune disease were selected for monitoring in the clinical database. Note: None of these events were identified in the clinic database.

Eligibility Criteria

• Ages Eligible for Study: 9 Months to 23 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• 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.

Criteria

Inclusion Criteria:

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

Contacts and Locations

Locations

United States, California

Oakland, California, United States, 94612

Sponsors and Collaborators

Sanofi Pasteur, a Sanofi Company

Investigators

• Study Director: Medical Director; Sanofi Pasteur Inc.

More Information

Additional Information:

Related Info 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Sanofi Pasteur, a Sanofi Company
• ClinicalTrials.gov Identifier: NCT01689155
• Other Study ID Numbers: MTA57; U 1111-1120-1574 ( Other Identifier: WHO )
• First Posted: September 21, 2012
• Results First Posted: November 11, 2016
• Last Update Posted: November 11, 2016
• Last Verified: September 2016

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):

Meningitis; Meningococcal Infection; Menactra®

Additional relevant MeSH terms:

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