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Trial record 1 of 1 for:    MTA38
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36-Month Post-marketing Surveillance and Analysis of Menactra Vaccine in 2-10 Year Olds

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ClinicalTrials.gov Identifier: NCT00728260
Recruitment Status : Completed
First Posted : August 5, 2008
Results First Posted : February 12, 2015
Last Update Posted : February 12, 2015
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Observational
Study Design Observational Model: Cohort
Conditions Meningitis
Meningococcal Disease
Intervention Biological: None administered in this study
Enrollment 1421
Recruitment Details Study participant accrual occurred from 18 October 2007 through 17 October 2010. Kaiser Permanente databases were reviewed for this study.
Pre-assignment Details Medical utilization databases were reviewed for children 2 through 10 years of age receiving Menactra vaccine within Kaiser Permanente to identify the following medical care events during the 6 months after Menactra vaccination: all outcomes from hospitalizations and emergency department visits and selected outcomes from clinic visits.
Arm/Group Title Menactra Vaccine Recipients
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 1421
Completed 1421
Not Completed 0
Arm/Group Title Menactra Vaccine Recipients
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 1421
Hide Baseline Analysis Population Description
Children 2 through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1421 participants
<=18 years
1421
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1421 participants
8.36  (2.55)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1421 participants
Female
709
  49.9%
Male
712
  50.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1421 participants
1421
Seasonality   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1421 participants
December - February 163
March - May 372
June - August 593
September - November 294
[1]
Measure Description: Data represent participants receiving vaccine during each time period shown. One participant had received more than one dose of Menactra vaccine; each dose is counted in the seasonality section.
Indication for Vaccination   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1421 participants
Asplenia (Surgical or Congenital) 17
Complement Deficiency 2
Hereditary Elliptocytosis 1
Hereditary Spherocytosis 8
Sickle Cell Disease 44
Thalassemias 22
Other Hemoglobinopathy 9
Human Immunodeficiency Virus Infection 1
Travel-Related 364
Not Available 987
[1]
Measure Description: Based on automated subject data. Participants may be included in more than 1 category
1.Primary Outcome
Title Summary of Diagnoses With Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level.
Hide Description 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.
Time Frame Day 0 up to Day 30 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All persons who received Menactra vaccine during the study period were included in the analysis.
Arm/Group Title Menactra Vaccine Recipients
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1421
Measure Type: Number
Unit of Measure: Events per 1,000 person-months
Cellulitis and abscess (All ages combined; H) 1.4
Cellulitis and abscess (Subj.10 Yrs Old; H; n=870) 2.3
2.Primary Outcome
Title Summary of Diagnoses With Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level.
Hide Description 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.
Time Frame Day 31 up to Day 180 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All persons who received Menactra vaccine during the study period were included in the analysis.
Arm/Group Title Menactra Vaccine Recipients
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1421
Measure Type: Number
Unit of Measure: Events per 1,000 person-months
Cellulitis and abscess (All ages combined; H) 0.0
Cellulitis and abscess (Subj.10 Yrs Old; H; n=870) 0.0
3.Other Pre-specified Outcome
Title Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database – All Ages Combined
Hide Description Only persons who received Menactra vaccine during the study period were surveyed and included in this outcome.
Time Frame Day 0 up to 6 months post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Only persons who received Menactra vaccine during the study period were included in the analysis.
Arm/Group Title Menactra Vaccine Recipients
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1421
Measure Type: Number
Unit of Measure: Events per 1,000 doses
Abdominal pain 0.70
Aspergillosis 0.70
Asthma 0.70
Cellulitis and abscess 1.41
Cerebral palsy 0.70
Congenital anomaly of ureter 0.70
Congenital atresia 0.70
Digestive congenital anomalies 070
Febrile illness 2.81
Feeding problem 0.70
Hereditary spherocytosis 0.70
Hydronephrosis 0.70
Malignant neoplasm 5.63
Other non-traumatic joint disorders 0.70
Pneumonia 0.70
Psychiatric 0.70
Pyogenic arthritis 0.70
Respiratory infection, upper 0.70
Sickle cell anemia 5.63
Small bowel obstruction 0.70
Trauma 2.11
Time Frame Surveillance period for serious adverse events was from the day of vaccination up to 6 months post-vaccination from the inpatient database.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Menactra Vaccine Recipients
Hide Arm/Group Description

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.

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   16/1421 (1.13%) 
Congenital, familial and genetic disorders   
Congenital Anomaly of ureter * 1  1/1421 (0.07%) 
Sickle Cell Anemia * 1  8/1421 (0.56%) 
Digestive congenital anomalies * 1  1/1421 (0.07%) 
Congenital atresia * 1  1/1421 (0.07%) 
Cerebral palsy * 1  1/1421 (0.07%) 
Hereditary spherocytosis * 1  1/1421 (0.07%) 
Gastrointestinal disorders   
Abdominal Pain * 1  1/1421 (0.07%) 
Small bowel obstruction * 1  1/1421 (0.07%) 
General disorders   
Febrile Illness * 1  4/1421 (0.28%) 
Infections and infestations   
Aspergillosis * 1  1/1421 (0.07%) 
Pyogenic arthritis * 1  1/1421 (0.07%) 
Respiratory infection, upper * 1  1/1421 (0.07%) 
Cellulitis and abscess * 1  2/1421 (0.14%) 
Pneumonia * 1  1/1421 (0.07%) 
Injury, poisoning and procedural complications   
Trauma * 1  3/1421 (0.21%) 
Metabolism and nutrition disorders   
Feeding problem * 1  1/1421 (0.07%) 
Musculoskeletal and connective tissue disorders   
Other non-traumatic joint disorders * 1  1/1421 (0.07%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Malignant neoplasm * 1  8/1421 (0.56%) 
Psychiatric disorders   
Psychiatric * 1  1/1421 (0.07%) 
Renal and urinary disorders   
Hydronephrosis * 1  1/1421 (0.07%) 
Respiratory, thoracic and mediastinal disorders   
Asthma * 1  1/1421 (0.07%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
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   0/1421 (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: NCT00728260     History of Changes
Other Study ID Numbers: MTA38
First Submitted: May 7, 2008
First Posted: August 5, 2008
Results First Submitted: January 7, 2015
Results First Posted: February 12, 2015
Last Update Posted: February 12, 2015