Trial Outcomes & Findings for Zanamivir Versus Trivalent Split Virus Influenza Vaccine (NCT NCT00784784)

NCT ID: NCT00784784

Last Updated: 2014-11-21

Results Overview

Four-fold increase in antibody titer 2 weeks post injection and end of study or positive laboratory test for influenza during study (polymerase chain reaction \[PCR\] or culture)

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 64 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2014-11-21

Participant Flow

Recruitment period: November 5th to November 19th, 2008 in Toronto, Ontario Canada. Most subjects were healthcare workers employed at a 470-bed acute care facility.

Participant milestones

Measure	Influenza Vaccine Influenza vaccine, using Fluviral trivalent split virus vaccine	Antiviral Prophylaxis Zanamivir, 10mg once daily during period of influenza activity, as prophylaxis
Overall Study STARTED	22	42
Overall Study COMPLETED	20	40
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Measure	Influenza Vaccine Influenza vaccine, using Fluviral trivalent split virus vaccine	Antiviral Prophylaxis Zanamivir, 10mg once daily during period of influenza activity, as prophylaxis
Overall Study Withdrawal by Subject	2	2

Baseline Characteristics

Zanamivir Versus Trivalent Split Virus Influenza Vaccine

Baseline characteristics by cohort

Measure	Influenza Vaccine n=22 Participants Influenza vaccine, using Fluviral trivalent split virus vaccine	Antiviral Prophylaxis n=42 Participants Zanamivir, 10mg once daily during period of influenza activity, as prophylaxis	Total n=64 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants	42 Participants n=7 Participants	64 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	40 years STANDARD_DEVIATION 10 • n=5 Participants	40 years STANDARD_DEVIATION 10 • n=7 Participants	40 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	27 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	15 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment Canada	22 participants n=5 Participants	42 participants n=7 Participants	64 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: intention to treat

Four-fold increase in antibody titer 2 weeks post injection and end of study or positive laboratory test for influenza during study (polymerase chain reaction [PCR] or culture)

Outcome measures

Measure	Influenza Vaccine n=20 Participants Influenza vaccine, using Fluviral trivalent split virus vaccine	Antiviral Prophylaxis n=40 Participants Zanamivir, 10mg once daily during period of influenza activity, as prophylaxis
Number of Laboratory Confirmed Influenza Infections	2 infections	1 infections

SECONDARY outcome

Timeframe: 5 months

Population: ITT

Number of subjects taking 80% or more doses per week of zanamivir (10 mg once daily), as influenza prophylaxis, for 13 weeks or longer (as measured by weekly diary and dose counts at study visits).

Outcome measures

Measure	Influenza Vaccine Influenza vaccine, using Fluviral trivalent split virus vaccine	Antiviral Prophylaxis n=40 Participants Zanamivir, 10mg once daily during period of influenza activity, as prophylaxis
Number of Subjects Adhering to Long-term Zanamivir Prophylaxis	—	34 participants Interval 29.0 to 37.0

Adverse Events

Influenza Vaccine

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Antiviral Prophylaxis

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Influenza Vaccine n=22 participants at risk；n=20 participants at risk Influenza vaccine, using Fluviral trivalent split virus vaccine	Antiviral Prophylaxis n=40 participants at risk Zanamivir, 10mg once daily during period of influenza activity, as prophylaxis
Musculoskeletal and connective tissue disorders Broken bone	0.00% 0/20 • 7 months Solicited and unsolicited adverse event reporting	2.5% 1/40 • Number of events 1 • 7 months Solicited and unsolicited adverse event reporting
Respiratory, thoracic and mediastinal disorders pneumonia	10.0% 2/20 • Number of events 2 • 7 months Solicited and unsolicited adverse event reporting	0.00% 0/40 • 7 months Solicited and unsolicited adverse event reporting

Other adverse events

Adverse event data not reported

Additional Information

Dr. Brenda Coleman

Mount Sinai Hospital

Phone: 416-586-4800

Email: bcoleman@mtsinai.on.ca

Results disclosure agreements

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