Trial Outcomes & Findings for Risk of Narcolepsy Associated With Administration of H1N1 Vaccine (NCT NCT01394614)

NCT ID: NCT01394614

Last Updated: 2015-05-14

Results Overview

Incidence rates will be computed by comparing narcolepsy incidence rates in exposed and non-exposed subjects. Comparison of narcolepsy incidence rates in the period prior to vaccine administration and pseudo-vaccine administration will be used to test the comparability of exposed and non-exposed group.

• Recruitment status: COMPLETED
• Target enrollment: 24 participants
• Primary outcome timeframe: Narcolepsy onset during the 16-week post-vaccination period.
• Results posted on: 2015-05-14

Participant Flow

Participant milestones

Measure	Narcoleptic Subjects Exposed to Vaccine Exposed narcoleptic subjects (vaccinated and onset of narcolepsy is after vaccine administration)	Unexposed Narcoleptic Subjects Unexposed narcoleptic subjects (not vaccinated or vaccinated after the onset of symptoms)
Overall Study STARTED	8	16
Overall Study COMPLETED	8	16
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Risk of Narcolepsy Associated With Administration of H1N1 Vaccine

Baseline characteristics by cohort

Measure	Exposed Narcoleptic Subjects n=8 Participants Exposed (vaccinated and onset of narcolepsy is after vaccine administration) narcoleptic subjects to adjuvanted A/H1N1 vaccine	Unexposed Narcoleptic Subjects n=16 Participants Unexposed (non-vaccinated or vaccinated after onset of symptoms) narcoleptic subjects to adjuvanted A/H1N1 vaccine	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	19.9 years n=5 Participants	26.1 years n=7 Participants	24.0 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	10 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment Canada	8 participants n=5 Participants	16 participants n=7 Participants	24 participants n=5 Participants

PRIMARY outcome

Timeframe: Narcolepsy onset during the 16-week post-vaccination period.

Incidence rates will be computed by comparing narcolepsy incidence rates in exposed and non-exposed subjects. Comparison of narcolepsy incidence rates in the period prior to vaccine administration and pseudo-vaccine administration will be used to test the comparability of exposed and non-exposed group.

Outcome measures

Measure	Exposed Narcoleptic Subjects n=8 Participants Exposed (vaccinated and onset of narcolepsy is post-vaccination) narcoleptic subjects Intervention: Adjuvanted (ASO3) A/H1N1 pandemic vaccine Arepanrix.	Unexposed Narcoleptic Subjects n=16 Participants Unexposed narcoleptic subjects (non-vaccinated or vaccinated after onset of symptoms)
Incidence of Narcolepsy Among Narcoleptic Subjects Exposed or Unexposed to Vaccine	0.52 events per 100,000 person-years	0.11 events per 100,000 person-years

Adverse Events

Exposed Narcoleptic Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Unexposed Narcoleptic Subjects

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

Dr. Jacques Montplaisir

Center for Advanced Research in Sleep Medicine

Phone: 514-388-2693

Email: jy.montplaisir@umontreal.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place