Trial Outcomes & Findings for Post-licensure Safety Surveillance Study of Menactra Vaccine When Administered As a 2-dose Schedule to Children (NCT NCT01689155)

Last Updated: 2016-11-11

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

116 participants

Primary outcome timeframe

Day 0 up to Day 75 post-vaccination

Results posted on

2016-11-11

Participant Flow

Study participant accrual occurred from 16 June 2011 through 20 June 2014.

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.

Participant milestones

Participant milestones
Measure	Menactra Vaccine Recipients 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 Study STARTED	116
Overall Study COMPLETED	116
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Menactra Vaccine Recipients n=116 Participants 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.
Age, Categorical <=18 years	116 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	15.9 Months STANDARD_DEVIATION 5.56 • n=5 Participants
Sex: Female, Male Female	61 Participants n=5 Participants
Sex: Female, Male Male	55 Participants n=5 Participants
Region of Enrollment United States	116 Participants n=5 Participants
Seasonality December - February	30 Participants n=5 Participants
Seasonality March - May	39 Participants n=5 Participants
Seasonality June - August	22 Participants n=5 Participants
Seasonality September - November	29 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0 up to Day 75 post-vaccination

Population: Eligible participants who received Menactra vaccine during the study period and captured in the KPNC databases were included in the analysis.

Outcome measures

Outcome measures
Measure	Menactra Vaccine Recipients n=116 Participants 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.	Control Group n=116 Participants 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.
Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database. Vomiting (ER)	0.009 Events per 1,000 person-months	0.000 Events per 1,000 person-months
Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database. Asthma	0.009 Events per 1,000 person-months	0.006 Events per 1,000 person-months
Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database. Cough	0.009 Events per 1,000 person-months	0.006 Events per 1,000 person-months
Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database. Febrile Seizure	0.009 Events per 1,000 person-months	0.000 Events per 1,000 person-months
Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database. Otitis Media	0.009 Events per 1,000 person-months	0.000 Events per 1,000 person-months
Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database. Trauma	0.019 Events per 1,000 person-months	0.000 Events per 1,000 person-months
Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database. Upper Respiratory Infection	0.009 Events per 1,000 person-months	0.000 Events per 1,000 person-months
Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database. Viral Syndrome	0.009 Events per 1,000 person-months	0.000 Events per 1,000 person-months

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 up to Day 75 post-vaccination

Population: All participants who received Menactra vaccine during the study period and captured in the KPNC databases were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	Menactra Vaccine Recipients n=116 Participants 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.	Control Group n=116 Participants 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.
Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Hospital Database.	0 Events per 1,000 person-months	0 Events per 1,000 person-months

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 up to Day 75 post-vaccination

Population: All participants who received Menactra vaccine during the study period and captured in the KPNC databases were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	Menactra Vaccine Recipients n=116 Participants 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.	Control Group n=116 Participants 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.
Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Clinic Database.	0 Events per 1,000 person-months	0 Events per 1,000 person-months

Adverse Events

Menactra Vaccine Recipients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Medical Drector

Sanofi Pasteur Inc

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
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Restriction type: OTHER