CompletedNCT01631071Updated Dec 20, 2013Results posted

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

An interventional study of Virosomal influenza vaccine in Influenza, sponsored by Crucell Holland BV. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-12-20.

Sponsored by Crucell Holland BV · Not applicable, Interventional, and Prevention

Phase: Not applicable
Study type: Interventional
Enrollment: 110
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The study is to assess whether the virosomal influenza vaccine for season 2012/2013 fulfills the EMA requirements for re-registration of influenza vaccines.

Conditions studied

Influenza

Browse trials for

Influenza, Human 2,214

Keywords

Influenza
Virus
Vaccination
Virosomal influenza vaccine

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 110 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Crucell Holland BV is the lead sponsor of 35 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Healthy female and male adults aged ≥18 on Day 1
Written informed consent
Female subjects of childbearing potential using and willing to continue using an acceptable method of contraception unless surgically sterilized/hysterectomized or post-menopausal for more than 2 years

Exclusion criteria

Exclusion Criteria:

Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease
Acute febrile illness (≥38.0 °C)
Prior vaccination with an influenza vaccine in the past 330 days
Known hypersensitivity to any vaccine component
Previous history of a serious adverse reaction to influenza vaccine
History of egg protein allergy or severe atopy
Known blood coagulation disorder
Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of the study vaccine, including oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent (inhaled or topical steroids are allowed)
Known immunodeficiency (incl. leukemia, HIV seropositivity), cancer
Investigational medicinal product received in the past 3 months (90 days) starting from the first day of the month following the last visit in a previous study
Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days)
Pregnancy or lactation
Participation in another clinical trial
Employee at the investigational site, or relative of the investigator
Subjects who in the view of the investigator will not comply with study procedures and/or visit requirements as per protocol

Study design

Phase: Not applicable
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 110 participants (actual)

Study arms

Experimental
Elderly subjects aged over 60 years
Biological: Virosomal influenza vaccine
Experimental
Adults from 18 to 60 years old inclusive
Biological: Virosomal influenza vaccine

Interventions

BiologicalVirosomal influenza vaccine
Intramuscular administration (M. deltoideus) of a single dose of 0.5 mL virosomal influenza vaccine

What researchers measure

Primary outcomes

Seroprotection
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)
Time frame: Day 22 +/- 2 days
Seroconversion
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)
Time frame: Day 22 +/- 2 days
Geometric Mean Titer
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)
Time frame: Day 22 +/- 2 days

Secondary outcomes

Number of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability
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
Time frame: Baseline (Day 1) and 3 weeks after vaccination (Day 22 ± 2 days)

Results

Posted Dec 20, 2013

Participant flow

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

Participant flow — Overall Study
Milestone	Elderly Subjects Aged Over 60 Years	Adults From 18 to 60 Years Old Inclusive
Started	55	55
Completed	55	55
Not completed	0	0

Outcome measures

PrimarySeroprotection

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)

Time frame:: Day 22 +/- 2 days
Reported as:: Number · percentage of subjects

Seroprotection
percentage of subjects	Elderly Subjects Aged Over 60 Years	Adults From 18 to 60 Years Old Inclusive
Percentage seroprotected subjects: A/H1N1	94.5 (84.9 to 98.9)	100 (93.5 to 100)
Percentage seroprotected subjects: A/H3N2	100 (93.5 to 100)	100 (93.5 to 100)
Percentage seroprotected subjects: B strain	100 (93.5 to 100)	100 (93.5 to 100)

SecondaryNumber of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability

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

Time frame:: Baseline (Day 1) and 3 weeks after vaccination (Day 22 ± 2 days)
Reported as:: Number · participants

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

PrimarySeroconversion

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)

Time frame:: Day 22 +/- 2 days
Reported as:: Number · percentage of subjects

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

PrimaryGeometric Mean Titer

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)

Time frame:: Day 22 +/- 2 days
Reported as:: Number · GMT fold increase from baseline

Geometric Mean Titer
GMT fold increase from baseline	Elderly Subjects Aged Over 60 Years	Adults From 18 to 60 Years Old Inclusive
GMT fold increase: A/H1N1	4.25 (3.26 to 5.54)	4.62 (3.48 to 6.15)
GMT fold increase: A/H3N2	2.70 (2.18 to 3.33)	2.78 (2.24 to 3.44)
GMT fold increase: B strain	2.78 (2.30 to 3.36)	3.27 (2.59 to 4.13)

Adverse events

Non-serious events are listed at a 0.5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Elderly Subjects Aged Over 60 Years	—	0/55 (0%)	23/55 (41.8%)
Adults From 18 to 60 Years Old Inclusive	—	0/55 (0%)	32/55 (58.2%)

Most frequent other events

Showing 10 of 13

Most frequent other events
Event	Elderly Subjects Aged Over 60 Years	Adults From 18 to 60 Years Old Inclusive
Injection site painGeneral disorders	17/55	28/55
Injection site indurationGeneral disorders	7/55	12/55
Injection site erythemaGeneral disorders	9/55	10/55
MalaiseGeneral disorders	1/55	7/55
HeadacheNervous system disorders	2/55	2/55
MalaiseGeneral disorders	1/55	0/55
Injection site haemorrhageGeneral disorders	1/55	0/55
Chills (shivering)General disorders	1/55	1/55
NasopharyngitisInfections and infestations	0/55	1/55
Muscle strainInjury, poisoning and procedural complications	0/55	1/55

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Elderly Subjects Aged Over 60 Years	Adults From 18 to 60 Years Old Inclusive	Total
<=18 years	0	0	0
Between 18 and 65 years	23	55	78
>=65 years	32	0	32

Age, Continuous
Age, Continuous(years)	Elderly Subjects Aged Over 60 Years	Adults From 18 to 60 Years Old Inclusive	Total
Mean	66.2 ± 4.42	41.0 ± 11.52	53.6 ± 15.37

Sex: Female, Male
Sex: Female, Male(Participants)	Elderly Subjects Aged Over 60 Years	Adults From 18 to 60 Years Old Inclusive	Total
Female	34	30	64
Male	21	25	46

Region of Enrollment
Region of Enrollment(participants)	Elderly Subjects Aged Over 60 Years	Adults From 18 to 60 Years Old Inclusive	Total
Switzerland	55	55	110

Study locations

1 site

CROSS-Research SA
Arzo, 6864, Switzerland

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 20, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01631071
Lead sponsor: Crucell Holland BV
Responsible party: Sponsor
First posted: Jun 28, 2012
Start date: Jul 2012
Primary completion: Aug 2012
Completion: Aug 2012
Results posted: Dec 20, 2013
Last update: Dec 20, 2013

Study contacts

Milko Radicioni, MD

principal investigator · CROSS-Research SA

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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