Trial Outcomes & Findings for A Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2009/2010 Influenza Virus Strains for the Northern Hemisphere (NCT NCT01306253)

Results Overview

Seroconversion rate was defined as the number of subjects with ≥4-fold increase in haemagglutination inhibition (HI) antibody titer and with a titer of ≥1:40

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

114 participants

Primary outcome timeframe

Day 22 ± 2 days

Results posted on

2013-09-09

Participant Flow

Participants were recruited at one center in Switzerland First subject first visit (FSFV): 05-Jun-2009 Last subject last visit (LSLV): 30-Jun-2009

Participant milestones

Participant milestones
Measure	Adults Adults from 18 to 60 years old inclusive	Elderly Elderly subjects aged over 60 years
Overall Study STARTED	57	57
Overall Study COMPLETED	56	56
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Adults Adults from 18 to 60 years old inclusive	Elderly Elderly subjects aged over 60 years
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

A Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2009/2010 Influenza Virus Strains for the Northern Hemisphere

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adults n=57 Participants Adults from 18 to 60 years old inclusive	Elderly n=57 Participants Elderly subjects aged over 60 years	Total n=114 Participants Total of all reporting groups
Age Continuous	42.3 years STANDARD_DEVIATION 12.3 • n=5 Participants	68.5 years STANDARD_DEVIATION 5.8 • n=7 Participants	55.4 years STANDARD_DEVIATION 16.3 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	30 Participants n=7 Participants	61 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	27 Participants n=7 Participants	53 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 22 ± 2 days

Population: Intention-to-treat (ITT) and According-to-protocol (ATP) populations excludes one subject per group lost to follow up

Seroconversion rate was defined as the number of subjects with ≥4-fold increase in haemagglutination inhibition (HI) antibody titer and with a titer of ≥1:40

Outcome measures

Outcome measures
Measure	Adults n=56 Participants Adults from 18 to 60 years old inclusive	Elderly n=56 Participants Elderly subjects aged over 60 years
Seroconversion A/Brisbane/59/2007	29 Number of subjects	32 Number of subjects
Seroconversion A/Brisbane/10/2007	37 Number of subjects	35 Number of subjects
Seroconversion B/Brisbane/60/2008	34 Number of subjects	33 Number of subjects

PRIMARY outcome

Timeframe: Day 22 ± 2 days

Population: ITT/ATP

Seroprotection rate, defined as the number of subjects with HI antibody titer ≥1:40

Outcome measures

Outcome measures
Measure	Adults n=56 Participants Adults from 18 to 60 years old inclusive	Elderly n=56 Participants Elderly subjects aged over 60 years
Seroprotection A/Brisbane/59/2007	47 Number of subjects	47 Number of subjects
Seroprotection A/Brisbane/10/2007	49 Number of subjects	51 Number of subjects
Seroprotection B/Brisbane/60/2008	51 Number of subjects	46 Number of subjects

PRIMARY outcome

Timeframe: Day 22/Day 1

Population: ITT/ATP

GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value

Outcome measures

Outcome measures
Measure	Adults n=56 Participants Adults from 18 to 60 years old inclusive	Elderly n=56 Participants Elderly subjects aged over 60 years
Fold Increase in Geometric Mean Titer (GMT) A/Brisbane/59/2007	9.60 Fold (ratio)	5.93 Fold (ratio)
Fold Increase in Geometric Mean Titer (GMT) A/Brisbane/10/2007	9.25 Fold (ratio)	8.30 Fold (ratio)
Fold Increase in Geometric Mean Titer (GMT) B/Brisbane/60/2008	7.91 Fold (ratio)	6.93 Fold (ratio)

SECONDARY outcome

Timeframe: Days 1 to 4 inclusive, and Day 22

Population: Safety population includes all subjects who received study vaccine

Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination

Outcome measures

Outcome measures
Measure	Adults n=57 Participants Adults from 18 to 60 years old inclusive	Elderly n=57 Participants Elderly subjects aged over 60 years
Safety: Numbers of Subjects Reporting Solicited Local Adverse Events Ecchymosis	1 Subjects	0 Subjects
Safety: Numbers of Subjects Reporting Solicited Local Adverse Events Erythema	5 Subjects	3 Subjects
Safety: Numbers of Subjects Reporting Solicited Local Adverse Events Induration	1 Subjects	2 Subjects
Safety: Numbers of Subjects Reporting Solicited Local Adverse Events Pain	18 Subjects	8 Subjects

SECONDARY outcome

Timeframe: Days 1 to 4 inclusive, and Day 22

Population: Safety population

Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination

Outcome measures

Outcome measures
Measure	Adults n=57 Participants Adults from 18 to 60 years old inclusive	Elderly n=57 Participants Elderly subjects aged over 60 years
Numbers of Subjects Reporting Solicited Systemic Adverse Events Malaise	1 Subjects	0 Subjects
Numbers of Subjects Reporting Solicited Systemic Adverse Events Shivering	0 Subjects	0 Subjects
Numbers of Subjects Reporting Solicited Systemic Adverse Events Fever	0 Subjects	0 Subjects

Adverse Events

Adults

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Elderly

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Adults n=57 participants at risk Adults from 18 to 60 years old inclusive	Elderly n=57 participants at risk Elderly subjects aged over 60 years
General disorders Pain	31.6% 18/57 • Number of events 18 • Safety assessments were made by the investigator at baseline and on Day 22 (± 2 days), and by subjects themselves (Subject Diary) for the 4-day period post-vaccination. SAE surveillance extended to 6 months post-vaccination.	14.0% 8/57 • Number of events 8 • Safety assessments were made by the investigator at baseline and on Day 22 (± 2 days), and by subjects themselves (Subject Diary) for the 4-day period post-vaccination. SAE surveillance extended to 6 months post-vaccination.
General disorders Induration	1.8% 1/57 • Number of events 1 • Safety assessments were made by the investigator at baseline and on Day 22 (± 2 days), and by subjects themselves (Subject Diary) for the 4-day period post-vaccination. SAE surveillance extended to 6 months post-vaccination.	3.5% 2/57 • Number of events 2 • Safety assessments were made by the investigator at baseline and on Day 22 (± 2 days), and by subjects themselves (Subject Diary) for the 4-day period post-vaccination. SAE surveillance extended to 6 months post-vaccination.
General disorders Erythema	8.8% 5/57 • Number of events 5 • Safety assessments were made by the investigator at baseline and on Day 22 (± 2 days), and by subjects themselves (Subject Diary) for the 4-day period post-vaccination. SAE surveillance extended to 6 months post-vaccination.	5.3% 3/57 • Number of events 3 • Safety assessments were made by the investigator at baseline and on Day 22 (± 2 days), and by subjects themselves (Subject Diary) for the 4-day period post-vaccination. SAE surveillance extended to 6 months post-vaccination.
General disorders Ecchymosis	1.8% 1/57 • Number of events 1 • Safety assessments were made by the investigator at baseline and on Day 22 (± 2 days), and by subjects themselves (Subject Diary) for the 4-day period post-vaccination. SAE surveillance extended to 6 months post-vaccination.	0.00% 0/57 • Safety assessments were made by the investigator at baseline and on Day 22 (± 2 days), and by subjects themselves (Subject Diary) for the 4-day period post-vaccination. SAE surveillance extended to 6 months post-vaccination.
General disorders Injection site pruritus	0.00% 0/57 • Safety assessments were made by the investigator at baseline and on Day 22 (± 2 days), and by subjects themselves (Subject Diary) for the 4-day period post-vaccination. SAE surveillance extended to 6 months post-vaccination.	1.8% 1/57 • Number of events 1 • Safety assessments were made by the investigator at baseline and on Day 22 (± 2 days), and by subjects themselves (Subject Diary) for the 4-day period post-vaccination. SAE surveillance extended to 6 months post-vaccination.
General disorders Malaise	1.8% 1/57 • Number of events 1 • Safety assessments were made by the investigator at baseline and on Day 22 (± 2 days), and by subjects themselves (Subject Diary) for the 4-day period post-vaccination. SAE surveillance extended to 6 months post-vaccination.	0.00% 0/57 • Safety assessments were made by the investigator at baseline and on Day 22 (± 2 days), and by subjects themselves (Subject Diary) for the 4-day period post-vaccination. SAE surveillance extended to 6 months post-vaccination.
Blood and lymphatic system disorders Lymphadenopathy	1.8% 1/57 • Number of events 1 • Safety assessments were made by the investigator at baseline and on Day 22 (± 2 days), and by subjects themselves (Subject Diary) for the 4-day period post-vaccination. SAE surveillance extended to 6 months post-vaccination.	0.00% 0/57 • Safety assessments were made by the investigator at baseline and on Day 22 (± 2 days), and by subjects themselves (Subject Diary) for the 4-day period post-vaccination. SAE surveillance extended to 6 months post-vaccination.
Nervous system disorders Dizziness	0.00% 0/57 • Safety assessments were made by the investigator at baseline and on Day 22 (± 2 days), and by subjects themselves (Subject Diary) for the 4-day period post-vaccination. SAE surveillance extended to 6 months post-vaccination.	1.8% 1/57 • Number of events 1 • Safety assessments were made by the investigator at baseline and on Day 22 (± 2 days), and by subjects themselves (Subject Diary) for the 4-day period post-vaccination. SAE surveillance extended to 6 months post-vaccination.
Nervous system disorders Headache	3.5% 2/57 • Number of events 2 • Safety assessments were made by the investigator at baseline and on Day 22 (± 2 days), and by subjects themselves (Subject Diary) for the 4-day period post-vaccination. SAE surveillance extended to 6 months post-vaccination.	0.00% 0/57 • Safety assessments were made by the investigator at baseline and on Day 22 (± 2 days), and by subjects themselves (Subject Diary) for the 4-day period post-vaccination. SAE surveillance extended to 6 months post-vaccination.
Nervous system disorders Monoparesis	0.00% 0/57 • Safety assessments were made by the investigator at baseline and on Day 22 (± 2 days), and by subjects themselves (Subject Diary) for the 4-day period post-vaccination. SAE surveillance extended to 6 months post-vaccination.	1.8% 1/57 • Number of events 1 • Safety assessments were made by the investigator at baseline and on Day 22 (± 2 days), and by subjects themselves (Subject Diary) for the 4-day period post-vaccination. SAE surveillance extended to 6 months post-vaccination.

Additional Information

Medical Affairs Director

Crucell Switzerland AG

Phone: +41(0)319806111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The investigator to submit all manuscripts/abstracts to the sponsor for review at least 6 weeks before submission.
Publication restrictions are in place

Restriction type: OTHER