Trial Outcomes & Findings for A Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2010/2011 Influenza Virus Strains for the Northern Hemisphere (NCT NCT01306305)

Last Updated: 2013-09-09

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

110 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): 28-Jun-2010 Last subject last visit (LSLV): 20-Jul-2010

Participant milestones

Participant milestones
Measure	Adults Adults from 18 to 60 years old inclusive	Elderly Elderly subjects aged over 60 years
Overall Study STARTED	55	55
Overall Study COMPLETED	53	55
Overall Study NOT COMPLETED	2	0

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	0
Overall Study Withdrew consent	1	0

Baseline Characteristics

A Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2010/2011 Influenza Virus Strains for the Northern Hemisphere

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adults n=55 Participants Adults from 18 to 60 years old inclusive	Elderly n=55 Participants Elderly subjects aged over 60 years	Total n=110 Participants Total of all reporting groups
Age Continuous	43.0 years STANDARD_DEVIATION 11.9 • n=5 Participants	69.8 years STANDARD_DEVIATION 5.7 • n=7 Participants	56.4 years STANDARD_DEVIATION 16.4 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	28 Participants n=7 Participants	57 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 lost to follow up and one subject who withdrew consent

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=53 Participants Adults from 18 to 60 years old inclusive	Elderly n=55 Participants Elderly subjects aged over 60 years
Seroconversion A/California/7/2009	43 Number of subjects	50 Number of subjects
Seroconversion A/Perth/16/2009	45 Number of subjects	48 Number of subjects
Seroconversion B/Brisbane/60/2008	27 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=53 Participants Adults from 18 to 60 years old inclusive	Elderly n=55 Participants Elderly subjects aged over 60 years
Seroprotection A/California/7/2009	45 Number of subjects	51 Number of subjects
Seroprotection A/Perth/16/2009	52 Number of subjects	55 Number of subjects
Seroprotection B/Brisbane/60/2008	50 Number of subjects	51 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=53 Participants Adults from 18 to 60 years old inclusive	Elderly n=55 Participants Elderly subjects aged over 60 years
Fold Increase in Geometric Mean Titer (GMT) A/California/7/2009	25.9 Fold (ratio)	30.8 Fold (ratio)
Fold Increase in Geometric Mean Titer (GMT) A/Perth/16/2009	10.6 Fold (ratio)	14.0 Fold (ratio)
Fold Increase in Geometric Mean Titer (GMT) B/Brisbane/60/2008	6.1 Fold (ratio)	5.7 Fold (ratio)

SECONDARY outcome

Timeframe: Days 1 to 4 inclusive, and Days 8, 15 and 22

Population: Safety population includes all subjects who received study vaccine

Safety assessments are made by the investigator at baseline and on Days 8, 15 and 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=55 Participants Adults from 18 to 60 years old inclusive	Elderly n=55 Participants Elderly subjects aged over 60 years
Safety: Numbers of Subjects Reporting Solicited Local Adverse Events Ecchymosis	1 Subjects	2 Subjects
Safety: Numbers of Subjects Reporting Solicited Local Adverse Events Erythema	16 Subjects	16 Subjects
Safety: Numbers of Subjects Reporting Solicited Local Adverse Events Induration	6 Subjects	6 Subjects
Safety: Numbers of Subjects Reporting Solicited Local Adverse Events Pain	20 Subjects	9 Subjects

SECONDARY outcome

Timeframe: Days 1 to 4 inclusive, and Days 8, 15 and 22

Population: Safety population

Safety assessments are made by the investigator at baseline and on Days 8, 15 and 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=55 Participants Adults from 18 to 60 years old inclusive	Elderly n=55 Participants Elderly subjects aged over 60 years
Numbers of Subjects Reporting Solicited Systemic Adverse Events Fever	0 Subjects	2 Subjects
Numbers of Subjects Reporting Solicited Systemic Adverse Events Shivering	0 Subjects	0 Subjects
Numbers of Subjects Reporting Solicited Systemic Adverse Events Malaise	2 Subjects	3 Subjects

Adverse Events

Adults

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

Elderly

Serious events: 1 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Adults n=55 participants at risk Adults from 18 to 60 years old inclusive	Elderly n=55 participants at risk Elderly subjects aged over 60 years
Infections and infestations Pneumonia	0.00% 0/55 • Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.	1.8% 1/55 • Number of events 1 • Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.

Other adverse events

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

Measure	Adults n=55 participants at risk Adults from 18 to 60 years old inclusive	Elderly n=55 participants at risk Elderly subjects aged over 60 years
Ear and labyrinth disorders Ear pain	1.8% 1/55 • Number of events 1 • Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.	0.00% 0/55 • Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.
Gastrointestinal disorders Diarrhea	5.5% 3/55 • Number of events 3 • Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.	0.00% 0/55 • Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.
Gastrointestinal disorders Nausea	3.6% 2/55 • Number of events 2 • Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.	0.00% 0/55 • Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.
Gastrointestinal disorders Odynophagia	0.00% 0/55 • Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.	1.8% 1/55 • Number of events 1 • Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.
Gastrointestinal disorders Toothache	0.00% 0/55 • Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.	1.8% 1/55 • Number of events 1 • Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.
General disorders Fatigue	1.8% 1/55 • Number of events 1 • Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.	0.00% 0/55 • Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.
General disorders Injection site erythema	29.1% 16/55 • Number of events 16 • Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.	29.1% 16/55 • Number of events 16 • Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.
General disorders Injection site haemorrhage (ecchymosis)	1.8% 1/55 • Number of events 1 • Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.	3.6% 2/55 • Number of events 2 • Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.
General disorders Injection site induration	10.9% 6/55 • Number of events 6 • Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.	10.9% 6/55 • Number of events 6 • Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.
General disorders Injection site pain	36.4% 20/55 • Number of events 20 • Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.	16.4% 9/55 • Number of events 9 • Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.
General disorders Malaise	3.6% 2/55 • Number of events 2 • Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.	5.5% 3/55 • Number of events 3 • Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.
General disorders Pyrexia (Fever)	0.00% 0/55 • Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.	3.6% 2/55 • Number of events 2 • Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.
Infections and infestations Nasopharyngitis	5.5% 3/55 • Number of events 3 • Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.	0.00% 0/55 • Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.
Injury, poisoning and procedural complications Arthropod bite	1.8% 1/55 • Number of events 1 • Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.	0.00% 0/55 • Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.
Injury, poisoning and procedural complications Heat stroke	1.8% 1/55 • Number of events 1 • Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.	0.00% 0/55 • Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.
Injury, poisoning and procedural complications Joint sprain	0.00% 0/55 • Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.	1.8% 1/55 • Number of events 1 • Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.
Nervous system disorders Dizziness	0.00% 0/55 • Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.	1.8% 1/55 • Number of events 1 • Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.
Nervous system disorders Headache	1.8% 1/55 • Number of events 1 • Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.	5.5% 3/55 • Number of events 3 • Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/55 • Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.	1.8% 1/55 • Number of events 1 • Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.