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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Conditions: Meningitis; Meningococcal Infection
• Intervention: Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
• Enrollment: 116

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		Menactra Vaccine Recipients
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
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.

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

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
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.
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

Outcome Measure Data

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
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.
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

Outcome Measure Data

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
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

Adverse Events

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
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	--/--
Serious Adverse Events
	Menactra Vaccine Recipients
	Affected / at Risk (%)
Total	0/116 (0.00%)
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%)

Limitations and Caveats

[Not Specified]

More Information

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
• EMail: RegistryContactus@sanofipasteur.com

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 ( Sanofi Pasteur, a Sanofi Company )
• ClinicalTrials.gov Identifier: NCT01689155
• 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