Trial Outcomes & Findings for Re-licensing Study to Assess Virosomal Influenza Vaccine Formulated With WHO Recommended Influenza Strains (NCT NCT01631071)

Last Updated: 2013-12-20

Results Overview

Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)

Recruitment status

COMPLETED

Study phase

Target enrollment

110 participants

Primary outcome timeframe

Day 22 +/- 2 days

Results posted on

2013-12-20

Participant Flow

Recruitment period: 03 August 2012 to 27 August 2012; outpatient study

Participant milestones

Participant milestones
Measure	Elderly Subjects Aged Over 60 Years	Adults From 18 to 60 Years Old Inclusive
Overall Study STARTED	55	55
Overall Study COMPLETED	55	55
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Re-licensing Study to Assess Virosomal Influenza Vaccine Formulated With WHO Recommended Influenza Strains

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Elderly Subjects Aged Over 60 Years n=55 Participants	Adults From 18 to 60 Years Old Inclusive n=55 Participants	Total n=110 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	23 Participants n=5 Participants	55 Participants n=7 Participants	78 Participants n=5 Participants
Age, Categorical >=65 years	32 Participants n=5 Participants	0 Participants n=7 Participants	32 Participants n=5 Participants
Age, Continuous	66.2 years STANDARD_DEVIATION 4.42 • n=5 Participants	41.0 years STANDARD_DEVIATION 11.52 • n=7 Participants	53.6 years STANDARD_DEVIATION 15.37 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	30 Participants n=7 Participants	64 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	25 Participants n=7 Participants	46 Participants n=5 Participants
Region of Enrollment Switzerland	55 participants n=5 Participants	55 participants n=7 Participants	110 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 22 +/- 2 days

Population: Intent-to-treat, vaccinated subjects with available pre- and post-vaccination titers

Outcome measures

Outcome measures
Measure	Elderly Subjects Aged Over 60 Years n=55 Participants	Adults From 18 to 60 Years Old Inclusive n=55 Participants
Seroprotection Percentage seroprotected subjects: A/H1N1	94.5 percentage of subjects Interval 84.9 to 98.9	100 percentage of subjects Interval 93.5 to 100.0
Seroprotection Percentage seroprotected subjects: A/H3N2	100 percentage of subjects Interval 93.5 to 100.0	100 percentage of subjects Interval 93.5 to 100.0
Seroprotection Percentage seroprotected subjects: B strain	100 percentage of subjects Interval 93.5 to 100.0	100 percentage of subjects Interval 93.5 to 100.0

PRIMARY outcome

Timeframe: Day 22 +/- 2 days

Population: Intent-to-treat, vaccinated subjects with available pre- and post-vaccination titers

Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)

Outcome measures

Outcome measures
Measure	Elderly Subjects Aged Over 60 Years n=55 Participants	Adults From 18 to 60 Years Old Inclusive n=55 Participants
Seroconversion Percentage seroconverted subjects: A/H1N1	43.6 percentage of subjects Interval 30.3 to 57.7	58.2 percentage of subjects Interval 44.1 to 71.3
Seroconversion Percentage seroconverted subjects: A/H3N2	27.3 percentage of subjects Interval 16.1 to 41.0	36.4 percentage of subjects Interval 23.8 to 50.4
Seroconversion Percentage seroconverted subjects: B strain	34.5 percentage of subjects Interval 22.2 to 48.6	43.6 percentage of subjects Interval 30.3 to 57.7

PRIMARY outcome

Timeframe: Day 22 +/- 2 days

Population: Intent-to-treat, vaccinated subjects with available pre- and post-vaccination titers

GMT of HI antibodies and fold-increase in GMT (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)

Outcome measures

Outcome measures
Measure	Elderly Subjects Aged Over 60 Years n=55 Participants	Adults From 18 to 60 Years Old Inclusive n=55 Participants
Geometric Mean Titer GMT fold increase: A/H1N1	4.25 GMT fold increase from baseline Interval 3.26 to 5.54	4.62 GMT fold increase from baseline Interval 3.48 to 6.15
Geometric Mean Titer GMT fold increase: A/H3N2	2.70 GMT fold increase from baseline Interval 2.18 to 3.33	2.78 GMT fold increase from baseline Interval 2.24 to 3.44
Geometric Mean Titer GMT fold increase: B strain	2.78 GMT fold increase from baseline Interval 2.3 to 3.36	3.27 GMT fold increase from baseline Interval 2.59 to 4.13

SECONDARY outcome

Timeframe: Baseline (Day 1) and 3 weeks after vaccination (Day 22 ± 2 days)

Solicited local and systemic AEs, Unsolicited AEs Unsolicited AEs were collected from baseline (Day 1) to 3 weeks after vaccination (Day 22 ± 2 days). Solicited local and systemic AEs were collected by subjects diary from Day 1 (day of vaccination) to Day 4

Outcome measures

Outcome measures
Measure	Elderly Subjects Aged Over 60 Years n=55 Participants	Adults From 18 to 60 Years Old Inclusive n=55 Participants
Number of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability AEs (unsolicited and unsolicited)	23 participants	32 participants
Number of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability Unsolicited AEs	4 participants	5 participants
Number of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability Solicited local AEs	20 participants	30 participants
Number of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability Solicited systemic AEs	1 participants	7 participants

Adverse Events

Elderly Subjects Aged Over 60 Years

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Adults From 18 to 60 Years Old Inclusive

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Elderly Subjects Aged Over 60 Years n=55 participants at risk	Adults From 18 to 60 Years Old Inclusive n=55 participants at risk
General disorders Malaise	1.8% 1/55 • Number of events 1	12.7% 7/55 • Number of events 7
General disorders Injection site erythema	16.4% 9/55 • Number of events 9	18.2% 10/55 • Number of events 10
General disorders Injection site haemorrhage	1.8% 1/55 • Number of events 1	0.00% 0/55
General disorders Injection site induration	12.7% 7/55 • Number of events 7	21.8% 12/55 • Number of events 12
General disorders Injection site pain	30.9% 17/55 • Number of events 17	50.9% 28/55 • Number of events 28
General disorders Chills (shivering)	1.8% 1/55 • Number of events 1	1.8% 1/55 • Number of events 1
Infections and infestations Nasopharyngitis	0.00% 0/55	1.8% 1/55 • Number of events 1
Injury, poisoning and procedural complications Muscle strain	0.00% 0/55	1.8% 1/55 • Number of events 1
Nervous system disorders Dizziness	1.8% 1/55 • Number of events 1	1.8% 1/55 • Number of events 1
Nervous system disorders Headache	3.6% 2/55 • Number of events 3	3.6% 2/55 • Number of events 2
Nervous system disorders Migraine	0.00% 0/55	1.8% 1/55 • Number of events 1
Skin and subcutaneous tissue disorders Rash	1.8% 1/55 • Number of events 1	0.00% 0/55

Additional Information

Medical Affairs Director

Crucell Switzerland AG

Phone: +41(0)319806111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Material for public dissemination will be submitted to the Sponsor for review at least ninety (90) days prior to submission for publication, public dissemination, or review by a publication committee.
Publication restrictions are in place

Restriction type: OTHER