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Trial record 1 of 1 for:    MTA57
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Post-licensure Safety Surveillance Study of Menactra Vaccine When Administered As a 2-dose Schedule to Children

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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:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Meningitis
Meningococcal Infection
Intervention Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
Enrollment 116
Recruitment Details Study participant accrual occurred from 16 June 2011 through 20 June 2014.
Pre-assignment Details Databases of Kaiser Permanente in Northern California (KPNC) were reviewed to describe and characterize adverse events occurring after use of Menactra vaccine in routine clinical practice. Rates of events occurring in a risk window for participants were compared with rates of events occurring in a control window for the same participants.
Arm/Group Title Menactra Vaccine Recipients
Hide Arm/Group Description Participants 9 months through 23 months of age receiving Menactra vaccine within the study institution following licensure of the vaccine for this age indication. KPNC databases were used; Menactra vaccine was administered according to routine clinical practice.
Period Title: Overall Study
Started 116
Completed 116
Not Completed 0
Arm/Group Title Menactra Vaccine Recipients
Hide Arm/Group Description Participants 9 months through 23 months of age receiving Menactra vaccine within the study institution following licensure of the vaccine for this age indication. KPNC databases were used; Menactra vaccine was administered according to routine clinical practice.
Overall Number of Baseline Participants 116
Hide Baseline Analysis Population Description
Participants age 9 months through 23 months of age receiving Menactra vaccine within the study institution following licensure of the vaccine for this age indication. KPNC databases were used; Menactra vaccine was administered according to routine clinical practice.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 116 participants
<=18 years
116
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 116 participants
15.9  (5.56)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 116 participants
Female
61
  52.6%
Male
55
  47.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 116 participants
116
Seasonality   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 116 participants
December - February 30
March - May 39
June - August 22
September - November 29
[1]
Measure Description: Data represent participants receiving vaccine during time period shown. Four participants received 2 doses of Menactra; each dose is accounted for in the appropriate time period.
1.Primary Outcome
Title Rates of Safety Outcomes at Days 0–30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database.
Hide Description 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.
Time Frame Day 0 up to Day 75 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants who received Menactra vaccine during the study period and captured in the KPNC databases were included in the analysis.
Arm/Group Title Menactra Vaccine Recipients Control Group
Hide Arm/Group Description:
Participants 9 months through 23 months of age receiving Menactra vaccine within the study institution following licensure of the vaccine for this age indication. KPNC databases were used; Menactra vaccine was administered according to routine clinical practice.
There was no separate control group per se. For all analyses, rates of events in a risk window for participants were compared with rates of events in a control window for the same participants.
Overall Number of Participants Analyzed 116 116
Measure Type: Number
Unit of Measure: Events per 1,000 person-months
Asthma 0.009 0.006
Cough 0.009 0.006
Febrile Seizure 0.009 0.000
Otitis Media 0.009 0.000
Trauma 0.019 0.000
Upper Respiratory Infection 0.009 0.000
Viral Syndrome 0.009 0.000
Vomiting (ER) 0.009 0.000
2.Other Pre-specified Outcome
Title Rates of Safety Outcomes at Days 0–30 vs Days 31-75 After Menactra Vaccine - Hospital Database.
Hide Description 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.
Time Frame Day 0 up to Day 75 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received Menactra vaccine during the study period and captured in the KPNC databases were included in the analysis.
Arm/Group Title Menactra Vaccine Recipients Control Group
Hide Arm/Group Description:
Participants 9 months through 23 months of age receiving Menactra vaccine within the study institution following licensure of the vaccine for this age indication. KPNC databases were used; Menactra vaccine was administered according to routine clinical practice.
There was no separate control group per se. For all analyses, rates of events in a risk window for participants were compared with rates of events in a control window for the same participants.
Overall Number of Participants Analyzed 116 116
Measure Type: Number
Unit of Measure: Events per 1,000 person-months
0 0
3.Other Pre-specified Outcome
Title Rates of Safety Outcomes at Days 0–30 vs Days 31-75 After Menactra Vaccine - Clinic Database.
Hide Description 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.
Time Frame Day 0 up to Day 75 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received Menactra vaccine during the study period and captured in the KPNC databases were included in the analysis.
Arm/Group Title Menactra Vaccine Recipients Control Group
Hide Arm/Group Description:
Participants 9 months through 23 months of age receiving Menactra vaccine within the study institution following licensure of the vaccine for this age indication. KPNC databases were used; Menactra vaccine was administered according to routine clinical practice.
There was no separate control group per se. For all analyses, rates of events in a risk window for participants were compared with rates of events in a control window for the same participants.
Overall Number of Participants Analyzed 116 116
Measure Type: Number
Unit of Measure: Events per 1,000 person-months
0 0
Time Frame Surveillance period for adverse events was from the day of vaccination to 6 months post-final vaccination, an average of 6 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Menactra Vaccine Recipients
Hide Arm/Group Description Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.
All-Cause Mortality
Menactra Vaccine Recipients
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Menactra Vaccine Recipients
Affected / at Risk (%)
Total   0/116 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.0%
Menactra Vaccine Recipients
Affected / at Risk (%)
Total   0/116 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
Results Point of Contact
Name/Title: Medical Drector
Organization: Sanofi Pasteur Inc
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01689155     History of Changes
Other Study ID Numbers: MTA57
U 1111-1120-1574 ( Other Identifier: WHO )
First Submitted: September 14, 2012
First Posted: September 21, 2012
Results First Submitted: August 1, 2016
Results First Posted: November 11, 2016
Last Update Posted: November 11, 2016