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CompletedNCT01229371Updated Sep 9, 2013Results posted

Immunogenicity and Safety Study to Assess Influenza Vaccine Formulated With Haemagglutinin (HA) Antigen From Two Suppliers

A Phase 3 interventional study of Inflexal V influenza vaccine (CSL HA Antigen) 2010 and Inflexal V influenza vaccine (AdImmune HA antigen) 2010/2011 in Influenza, sponsored by Crucell Holland BV. Completed at 2 sites in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-09-09.

Sponsored by Crucell Holland BV · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
440
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to assess the humoral immune response and safety of the parenteral formulation of the 2010/2011-season virosomal subunit influenza vaccine Inflexal V using two different HA antigen suppliers (AdImmune and CSL), in groups of young and elderly adults, using the EMA (European Medicines Agency) regulation as a guideline.

Read the detailed description

The objectives of this study are to evaluate the humoral immunogenicity and safety of the parenteral formulation of the 2010/2011-season influenza vaccine, Inflexal V, using HA antigen obtained from 2 different production facilities, and to compare the immunogenicity of both formulations to pre-defined EMA criteria for the annual relicensing of seasonal influenza vaccines. The evaluation will be done in young adults and elderly.

02

Conditions studied

  • Influenza

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Keywords

  • Influenza
  • Virus
  • Vaccination
  • Immunisation
03

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 440 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

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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.

04

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 years on Day 1
  • Written informed consent

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 (including the H1N1 pandemic swine flu 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, incl. oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent (inhaled or topical steroids are allowed)
  • Known immunodeficiency (incl. leukemia, cancer, HIV seropositivity)
  • Investigational medicinal product received in the past 3 months (90 days)
  • 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 spouse and children of the investigator, or relative living in the same household as the investigator and/or are dependent on the investigator
  • Suspected non-compliance
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
440 participants (actual)

Study arms

  • Active comparator
    Subjects ≥18 to ≤60 Years - CSL HA Antigen

    Inflexal V influenza vaccine (CSL HA Antigen) 2010 Group A will be vaccinated with Inflexal V influenza vaccine (surface antigen, inactivated, virosome, using CSL HA Antigen) 2010/2011 containing per 0.5 mL i.m. dose: 15 μg HA antigen of A/California/7/2009 (H1N1)-like virus; 15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus; 15 μg HA antigen of B/Brisbane/60/2008-like virus

    Biological: Inflexal V influenza vaccine (CSL HA Antigen) 2010

  • Active comparator
    Subjects >60 Years - CSL HA Antigen

    Inflexal V influenza vaccine (CSL HA Antigen) 2010 Group B will be vaccinated with Inflexal V influenza vaccine (surface antigen, inactivated, virosome, using CSL HA Antigen) 2010/2011 containing per 0.5 mL i.m. dose: 15 μg HA antigen of A/California/7/2009 (H1N1)-like virus; 15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus; 15 μg HA antigen of B/Brisbane/60/2008-like virus

    Biological: Inflexal V influenza vaccine (CSL HA Antigen) 2010

  • Experimental
    Subjects ≥18 to ≤60 Years - AdImmune HA Antigen

    Inflexal V influenza vaccine (AdImmune HA Antigen) 2010/2011 Group C will be vaccinated with Inflexal V influenza vaccine (surface antigen, inactivated, virosome, using AdImmune HA antigen) 2010/2011 containing per 0.5 mL i.m.dose: 15 μg HA antigen of A/California/7/2009 (H1N1)-like virus; 15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus; 15 μg HA antigen of B/Brisbane/60/2008-like virus

    Biological: Inflexal V influenza vaccine (AdImmune HA antigen) 2010/2011

  • Experimental
    Subjects >60 Years - AdImmune HA Antigen

    Inflexal V influenza vaccine (AdImmune HA Antigen) 2010/2011 Group D will be vaccinated with Inflexal V influenza vaccine (surface antigen, inactivated, virosome, using AdImmune HA antigen) 2010/2011 containing per 0.5 mL i.m.dose: 15 μg HA antigen of A/California/7/2009 (H1N1)-like virus; 15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus; 15 μg HA antigen of B/Brisbane/60/2008-like virus

    Biological: Inflexal V influenza vaccine (AdImmune HA antigen) 2010/2011

Interventions

  • BiologicalInflexal V influenza vaccine (CSL HA Antigen) 2010

    Inflexal V influenza vaccine (surface antigen, inactivated, virosome, using CSL HA Antigen) 2010/2011, with intramuscular administration, containing per 0.5 mL dose: 15 μg HA antigen of A/California/7/2009 (H1N1)-like virus; 15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus; 15 μg HA antigen of B/Brisbane/60/2008-like virus

  • BiologicalInflexal V influenza vaccine (AdImmune HA antigen) 2010/2011

    Inflexal V influenza vaccine (surface antigen, inactivated, virosome, using AdImmune HA antigen) 2010/2011 with intramuscular administration, containing per 0.5 mL dose: 15 μg HA antigen of A/California/7/2009 (H1N1)-like virus; 15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus; 15 μg HA antigen of B/Brisbane/60/2008-like virus

06

What researchers measure

Primary outcomes

  1. Immunogenicity - Geometric Mean Titer Fold Increase From Baseline

    The primary endpoints were 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 and they were the following: 1. Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40, 2. Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40, 3. GMT of HI antibodies and fold-increase in GMT

    Time frame: 3 weeks after vaccination (Day 22 ± 2 days)

  2. Immunogenicity - Seroprotection Rate

    The primary endpoints were 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 and they were the following: 1. Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40, 2. Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40, 3. GMT of HI antibodies and fold-increase in GMT

    Time frame: 3 weeks after vaccination (Day 22 ± 2 days)

  3. Immunogenicity - Seroconversion Rate

    The primary endpoints were 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 and they were the following: 1. Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40, 2. Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40, 3. GMT of HI antibodies and fold-increase in GMT

    Time frame: 3 weeks after vaccination (Day 22 ± 2 days)

Secondary outcomes

  1. Number of Participants With Local and Systemic Adverse Events

    Solicited local and systemic AEs, Unsolicited AEs, Tolerability and acceptability 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)

07

Results

Posted Mar 22, 2013

Participant flow

Recruitment period: 19 October 2010 to 09 November 2010; outpatient study

Participant flow — Overall Study
MilestoneSubjects ≥18 to ≤60 Years - AdImmune HA AntigenSubjects ≥18 to ≤60 Years - CSL HA AntigenSubjects >60 Years - AdImmune HA AntigenSubjects >60 Years - CSL HA Antigen
Started109111110110
Completed109110110110
Not completed0100
Withdrew: Withdrawal by subject0100

Outcome measures

PrimaryImmunogenicity - Geometric Mean Titer Fold Increase From Baseline

The primary endpoints were 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 and they were the following: 1. Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40, 2. Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40, 3. GMT of HI antibodies and fold-increase in GMT

Time frame:
3 weeks after vaccination (Day 22 ± 2 days)
Reported as:
Number · GMT fold increase
Immunogenicity - Geometric Mean Titer Fold Increase From Baseline
GMT fold increaseSubjects ≥18 to ≤60 Years - AdImmune HA AntigenSubjects ≥18 to ≤60 Years - CSL HA AntigenSubjects >60 Years - AdImmune HA AntigenSubjects >60 Years - CSL HA Antigen
GMT fold increase from baseline: A/H1N13.5 (2.8 to 4.3)4.0 (3.3 to 5.0)4.5 (3.6 to 5.7)3.4 (2.8 to 4.2)
GMT fold increase from baseline: A/H3N22.5 (2.1 to 3.0)2.5 (2.1 to 2.9)2.2 (1.8 to 2.6)1.9 (1.5 to 2.3)
GMT fold increase from baseline: B-strain3.2 (2.6 to 3.8)3.1 (2.6 to 3.7)1.9 (1.7 to 2.2)2.1 (1.8 to 2.4)
SecondaryNumber of Participants With Local and Systemic Adverse Events

Solicited local and systemic AEs, Unsolicited AEs, Tolerability and acceptability 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
participantsSubjects ≥18 to ≤60 Years - AdImmune HA AntigenSubjects ≥18 to ≤60 Years - CSL HA AntigenSubjects >60 Years - AdImmune HA AntigenSubjects >60 Years - CSL HA Antigen
AEs (unsolicited and solicited)57582530
Unsolicited AEs1421811
Solicited local AEs45411821
Solicited systemic AEs14964
PrimaryImmunogenicity - Seroprotection Rate

The primary endpoints were 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 and they were the following: 1. Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40, 2. Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40, 3. GMT of HI antibodies and fold-increase in GMT

Time frame:
3 weeks after vaccination (Day 22 ± 2 days)
Reported as:
Number · percentage subjects
Immunogenicity - Seroprotection Rate
percentage subjectsSubjects ≥18 to ≤60 Years - AdImmune HA AntigenSubjects ≥18 to ≤60 Years - CSL HA AntigenSubjects >60 Years - AdImmune HA AntigenSubjects >60 Years - CSL HA Antigen
Percentage of subjects seroprotected: A/H1N199.1 (95.0 to 100)98.2 (93.6 to 99.8)92.7 (82.8 to 96.8)90.0 (82.8 to 94.9)
Percentage of subjects seroprotected: A/H3N299.1 (95.0 to 100)99.1 (95.0 to 100)100 (96.7 to 100)99.1 (95.0 to 100)
Percentage of subjects seroprotected: B-strain96.3 (90.9 to 99.0)97.3 (92.2 to 99.4)85.5 (77.5 to 91.5)86.4 (78.5 to 92.2)
PrimaryImmunogenicity - Seroconversion Rate

The primary endpoints were 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 and they were the following: 1. Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40, 2. Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40, 3. GMT of HI antibodies and fold-increase in GMT

Time frame:
3 weeks after vaccination (Day 22 ± 2 days)
Reported as:
Number · percentage subjects
Immunogenicity - Seroconversion Rate
percentage subjectsSubjects ≥18 to ≤60 Years - AdImmune HA AntigenSubjects ≥18 to ≤60 Years - CSL HA AntigenSubjects >60 Years - AdImmune HA AntigenSubjects >60 Years - CSL HA Antigen
Percentage of subjects seroprotected: A/H1N145.0 (35.4 to 54.8)52.7 (43.0 to 62.3)54.5 (44.8 to 64.1)43.6 (34.2 to 53.4)
Percentage of subjects seroprotected: A/H3N227.5 (19.4 to 36.9)29.1 (20.8 to 38.5)25.5 (17.6 to 34.6)17.3 (10.7 to 25.7)
Percentage of subjects seroprotected: B-strain40.4 (31.1 to 50.2)44.5 (35.1 to 54.3)20.9 (13.7 to 29.7)20.0 (13.0 to 28.7)

Adverse events

Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Subjects ≥18 to ≤60 Years - AdImmune HA Antigen—0/109 (0%)57/109 (52.3%)
Subjects ≥18 to ≤60 Years - CSL HA Antigen—0/111 (0%)58/111 (52.3%)
Subjects >60 Years - AdImmune HA Antigen—0/110 (0%)25/110 (22.7%)
Subjects >60 Years - CSL HA Antigen—0/110 (0%)30/110 (27.3%)
Most frequent other events
Most frequent other events
EventSubjects ≥18 to ≤60 Years - AdImmune HA AntigenSubjects ≥18 to ≤60 Years - CSL HA AntigenSubjects >60 Years - AdImmune HA AntigenSubjects >60 Years - CSL HA Antigen
Pain (at the injection site)General disorders38/10939/11114/11014/110
MalaiseGeneral disorders12/1094/1116/1103/110
Induration (at the injection site)General disorders11/1098/1119/1105/110
Erythema (at the injection site)General disorders7/1096/1119/1105/110
ChillsGeneral disorders7/1093/1114/1101/110
Haemorrhage (at the injection site)General disorders1/1094/1110/1101/110
FatigueGeneral disorders3/1092/1110/1101/110
CoughRespiratory, thoracic and mediastinal disorders1/1093/1112/1100/110
NasopharyngitisInfections and infestations1/1092/1111/1102/110

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Subjects ≥18 to ≤60 Years - AdImmune HA AntigenSubjects ≥18 to ≤60 Years - CSL HA AntigenSubjects >60 Years - AdImmune HA AntigenSubjects >60 Years - CSL HA AntigenTotal
<=18 years00000
Between 18 and 65 years1091114753320
>=65 years006357120
Age Continuous
Age Continuous(years)Subjects ≥18 to ≤60 Years - AdImmune HA AntigenSubjects ≥18 to ≤60 Years - CSL HA AntigenSubjects >60 Years - AdImmune HA AntigenSubjects >60 Years - CSL HA AntigenTotal
Mean39.5 ± 11.1839.9 ± 12.1066.5 ± 5.5066.4 ± 5.0653.1 ± 16.14
Sex: Female, Male
Sex: Female, Male(Participants)Subjects ≥18 to ≤60 Years - AdImmune HA AntigenSubjects ≥18 to ≤60 Years - CSL HA AntigenSubjects >60 Years - AdImmune HA AntigenSubjects >60 Years - CSL HA AntigenTotal
Female54504953206
Male55616157234
Region of Enrollment
Region of Enrollment(participants)Subjects ≥18 to ≤60 Years - AdImmune HA AntigenSubjects ≥18 to ≤60 Years - CSL HA AntigenSubjects >60 Years - AdImmune HA AntigenSubjects >60 Years - CSL HA AntigenTotal
Switzerland109111110110440
08

Study locations

2 sites
  • Covance Clinical Research Unit AG
    Allschwil, 4123, Switzerland
  • Cross Research S.A. Phase I Unit
    Arzo, 6864, Switzerland
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01229371
Lead sponsor
Crucell Holland BV
Responsible party
Sponsor
First posted
Oct 27, 2010
Start date
Oct 2010
Primary completion
Dec 2010
Completion
Dec 2010
Results posted
Mar 22, 2013
Last update
Sep 9, 2013

Study contacts

Michael Seiberling, MD
principal investigator · Covance Clinical Research Unit AG

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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