Safety and Immunogenicity of Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture Using the Strain Composition 2007/2008

Phase 3

Completed

• Conditions: Seasonal Influenza Vaccine
• Interventions: Biological: cTIV

• Registration Number: NCT00511914
• Lead Sponsor: Novartis Vaccines

Brief Summary

Annual trial for registration of sub-unit influenza vaccine produced in mammalian cell culture, using the strain composition 2007/2008, when administered to adult and elderly subjects

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Study First Submitted: 2007-08-03
• Study First Submitted QC: 2007-08-03
• Study First Posted: 2007-08-06
• Results First Submitted: 2012-12-10
• Results First Submitted QC: 2012-12-10
• Status Verified: 2013-01
• Results First Posted: 2013-01-17
• Last Update Submitted: 2013-01-18
• Last Update Posted: 2013-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

Subjects eligible for enrollment into this study are male and female adults who were:

1. ≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry

2. available for all the visits scheduled in the study and able to comply with all study requirements

3. in good health as determined by:

   • medical history
   • physical examination
   • clinical judgment of the investigator Written informed consent had to be obtained from all the subjects before enrollment in the study after the nature of the study had been explained.

Exclusion Criteria

Subjects were not to be enrolled into the study if at least one of the following criteria was fulfilled:

1. Any serious chronic or acute disease such as:

   1. Cancer (leukemia, lymphomas, neoplasm), except for benign or localized skin cancer and non-metastatic prostate cancer not presently treated with chemotherapy
   2. Congestive heart failure
   3. Advanced arteriosclerotic disease
   4. Chronic obstructive pulmonary disease (COPD) requiring oxygen therapy and/or acute exacerbation of a COPD within the last 14 days.
   5. Autoimmune disease (including rheumatoid arthritis), if under immunosuppressive therapy (see below)
   6. Insulin dependent diabetes mellitus
   7. Acute or progressive hepatic disease
   8. Acute or progressive renal disease
   9. Severe neurological or psychiatric disorder

2. History of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine or chemically related substances

3. Known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) resulting for example from:

   1. Receipt of immunosuppressive therapy (chronic therapy with immunosuppressive drugs, any parenteral or oral corticosteroid (substitution dose in case of absence of suprarenal function allowed) or cancer chemotherapy/radiotherapy) within the last 2 months and for the full length of the study,
   2. Receipt of immunostimulants,
   3. Receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months and for the full length of the study,
   4. Suspected or known HIV infection or HIV-related disease.

4. Known or suspected history of drug or alcohol abuse

5. Bleeding diathesis or receive anticoagulants of the coumarin type

6. Women who are pregnant or woman of childbearing potential unwilling to practice acceptable contraception for the duration of the study (21 days)

7. Influenza immunization or laboratory confirmed influenza within the last 6 months and more than one influenza immunization within the past 12 months

8. Immunization with any other vaccine and/or any investigational vaccine four weeks prior to study start

9. Any significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days

10. Fever (i.e. body temperature ≥ 38.0°C) within the past 3 days prior to study entry

11. Simultaneous participation in another clinical study

12. Any condition, which, in the opinion of the investigator, might prevent the subject from participation or interfere with the evaluation of the study objectives.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cTIV (Adults)	cTIV	Received one dose of cell-culture derived trivalent influenza vaccine (cTIV).
cTIV (Elderly)	cTIV	Received one dose of cell-culture derived trivalent influenza vaccine (cTIV).

Primary Outcome Measures

Name	Time	Method
Geometric Mean Titers (GMT) After 1 Dose of Cell Culture Derived Vaccine (cTIV).	3 weeks postvaccination (Day 22)	Pre and postvaccination geometric mean titers against all 3 strains were assessed by hemagglutination inhibition (HI) assay using egg derived antigen in adults and elderly subjects.
Geometric Mean Ratio After 1 Dose of the Cell Culture Derived Vaccine (cTIV)	3 weeks postvaccination (Day 22)	Geometric mean ratio (GMR) of Day 22 / Day 1 geometric mean antibody titers was assessed by hemagglutination inhibition (HI)assay using egg derived antigen in adults and elderly subjects.; The criterion is met according to European (CHMP) guideline if the mean geometric increase GMR (Day22 / Day1) in HI antibody titer is \>2.5 for adults and \>2.0 for elderly subjects.
Percentages of Subjects With HI Titer ≥40 After 1 Dose of Cell Culture Derived Vaccine (cTIV).	3 weeks postvaccination (Day 22)	HI titer as assessed by hemagglutination inhibition (HI) assay using egg derived antigen in adults and elderly subjects.; This criterion is met according to European (CHMP) guideline if the percentages of subjects achieving HI titers ≥40 is \>70% for adults and \>60% for elderly subjects.
Percentages of Subjects With Seroconversion or Significant Increase After 1 Dose of Cell Culture Derived Vaccine (cTIV).	3 weeks postvaccination (Day 22)	Proportion of subjects with either seroconversion (antibody increase from \< 10 pre vaccination to ≥40 post vaccination) or significant increase (antibody titer of ≥10 pre vaccination and 4-fold antibody increase post vaccination).; According to the CHMP criteria, the percentages of subjects achieving seroconversion or significant increase should be \>40% for adults and \>30% for elderly subjects.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects Reporting Local and Systemic Reactions	3 days postvaccination	To evaluate the safety and tolerability of cell culture derived vaccine (cTIV) in adults and elderly subjects in terms of number of subjects reporting local and systemic reactions after 1 vaccine dose.

Trial Locations

Locations (2)

Z29, Blutspendezentrale, Gebaude Z29, Behringwerke; 🇩🇪 Emil-von-Behring-Str. 76, Marburg, Germany

Betriebsaerztlicher Dienst, Standort Marburg; 🇩🇪 Baldingerstrasse, Marburg Hessen, Germany