Trial Outcomes & Findings for A Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2008/2009 Influenza Virus Strains for the Northern Hemisphere (NCT NCT01303510)

NCT ID: NCT01303510

Last Updated: 2013-09-09

Results Overview

Seroconversion rate was defined as the proportion 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: 111 participants
• Primary outcome timeframe: Day 22 ± 2 days
• Results posted on: 2013-09-09

Participant Flow

Participants were recruited at one center in Switzerland FSFV: 09-Jul-2008 LSLV: 30-Jul-2008

Participant milestones

Measure	Group A Adults from 18 to 60 years old inclusive	Group B Elderly subjects aged over 60 years
Overall Study STARTED	55	56
Overall Study COMPLETED	54	56
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Group A Adults from 18 to 60 years old inclusive	Group B Elderly subjects aged over 60 years
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

A Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2008/2009 Influenza Virus Strains for the Northern Hemisphere

Baseline characteristics by cohort

Measure	Group A n=55 Participants Adults from 18 to 60 years old inclusive	Group B n=56 Participants Elderly subjects aged over 60 years	Total n=111 Participants Total of all reporting groups
Age Continuous	39.2 years STANDARD_DEVIATION 13.0 • n=5 Participants	69.3 years STANDARD_DEVIATION 5.2 • n=7 Participants	54.4 years STANDARD_DEVIATION 18.0 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	25 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	31 Participants n=7 Participants	60 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 22 ± 2 days

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

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

Outcome measures

Measure	Group A n=54 Participants Adults from 18 to 60 years old inclusive	Group B n=56 Participants Elderly subjects aged over 60 years
Seroconversion A/Brisbane/59/2007	27 Subjects	17 Subjects
Seroconversion A/Uruguay/716/2007	32 Subjects	43 Subjects
Seroconversion B/Florida/4/2006	34 Subjects	20 Subjects

PRIMARY outcome

Timeframe: Day 22 ± 2 days

Population: ITT/ATP

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

Outcome measures

Measure	Group A n=54 Participants Adults from 18 to 60 years old inclusive	Group B n=56 Participants Elderly subjects aged over 60 years
Seroprotection A/Brisbane/59/2007	52 Subjects	39 Subjects
Seroprotection A/Uruguay/716/2007	39 Subjects	49 Subjects
Seroprotection B/Florida/4/2006	53 Subjects	54 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

Measure	Group A n=54 Participants Adults from 18 to 60 years old inclusive	Group B n=56 Participants Elderly subjects aged over 60 years
Fold Increase in Geometric Mean Titer (GMT) A/Brisbane/59/2007	9.97 Fold (ratio)	4.36 Fold (ratio)
Fold Increase in Geometric Mean Titer (GMT) A/Uruguay/716/2007	11.54 Fold (ratio)	17.40 Fold (ratio)
Fold Increase in Geometric Mean Titer (GMT) B/Florida/4/2006	9.90 Fold (ratio)	2.36 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

Measure	Group A n=55 Participants Adults from 18 to 60 years old inclusive	Group B n=56 Participants Elderly subjects aged over 60 years
Safety: Incidence of Solicited Local Adverse Events Ecchymosis	1 Subjects	1 Subjects
Safety: Incidence of Solicited Local Adverse Events Erythema	6 Subjects	6 Subjects
Safety: Incidence of Solicited Local Adverse Events Induration	7 Subjects	3 Subjects
Safety: Incidence of Solicited Local Adverse Events Pain	30 Subjects	12 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

Measure	Group A n=54 Participants Adults from 18 to 60 years old inclusive	Group B n=56 Participants Elderly subjects aged over 60 years
Incidence of Solicited Systemic Adverse Events Shivering	0 Subjects	0 Subjects
Incidence of Solicited Systemic Adverse Events Malaise	8 Subjects	3 Subjects

Adverse Events

Group A

Serious events: 0 serious events

Other events: 36 other events

Deaths: 0 deaths

Group B

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Group A n=55 participants at risk Adults from 18 to 60 years old inclusive	Group B n=56 participants at risk Elderly subjects aged over 60 years
Gastrointestinal disorders Diarrhea	1.8% 1/55 • 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% 0/56 • 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.
Infections and infestations Nasopharyngitis	1.8% 1/55 • 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% 0/56 • 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.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/55 • 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% 1/56 • 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	1.8% 1/55 • 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% 0/56 • 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 Somnolence	1.8% 1/55 • 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% 0/56 • 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 Tension headache	0.00% 0/55 • 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% 1/56 • 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 Ecchymosis	1.8% 1/55 • 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.	1.8% 1/56 • 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 Erythema	10.9% 6/55 • Number of events 6 • 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.	10.7% 6/56 • Number of events 6 • 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	12.7% 7/55 • Number of events 7 • 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.	5.4% 3/56 • 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 Pain	54.5% 30/55 • Number of events 30 • 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.	21.4% 12/56 • Number of events 12 • 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	14.5% 8/55 • 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.	5.4% 3/56 • 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.

Additional Information

Medical Affairs Director

Crucell Switzerland AG

Phone: +41(0)319806111

Email: info@crucell.com

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