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

NCT00511914 | Completed Phase 3 Results

• 2 other identifiers: V58P1S2007-001404-20
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 2

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

Conditions

Seasonal Influenza Vaccine

Keywords

Influenza vaccine

Outcome Measures

Primary Outcomes (4)

• Geometric Mean Titers (GMT) After 1 Dose of Cell Culture Derived Vaccine (cTIV).

  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.

  3 weeks postvaccination (Day 22)

• Geometric Mean Ratio After 1 Dose of the Cell Culture Derived Vaccine (cTIV)

  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.

  3 weeks postvaccination (Day 22)

• Percentages of Subjects With HI Titer ≥40 After 1 Dose of Cell Culture Derived Vaccine (cTIV).

  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.

  3 weeks postvaccination (Day 22)

• Percentages of Subjects With Seroconversion or Significant Increase After 1 Dose of Cell Culture Derived Vaccine (cTIV).

  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.

  3 weeks postvaccination (Day 22)

Secondary Outcomes (1)

• Number of Subjects Reporting Local and Systemic Reactions

  3 days postvaccination

Study Arms (2)

cTIV (Adults)

EXPERIMENTAL

Received one dose of cell-culture derived trivalent influenza vaccine (cTIV).

Biological: cTIV

cTIV (Elderly)

EXPERIMENTAL

Received one dose of cell-culture derived trivalent influenza vaccine (cTIV).

Biological: cTIV

Interventions

cTIV BIOLOGICAL

One dose (0.5 mL) of cell culture-derived influenza vaccine, administered in the deltoid muscle

cTIV (Adults); cTIV (Elderly)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects eligible for enrollment into this study are male and female adults who were:
• ≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry
• available for all the visits scheduled in the study and able to comply with all study requirements
• 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.

You may not qualify if:

• Subjects were not to be enrolled into the study if at least one of the following criteria was fulfilled:
• Any serious chronic or acute disease such as:
• Cancer (leukemia, lymphomas, neoplasm), except for benign or localized skin cancer and non-metastatic prostate cancer not presently treated with chemotherapy
• Congestive heart failure
• Advanced arteriosclerotic disease
• Chronic obstructive pulmonary disease (COPD) requiring oxygen therapy and/or acute exacerbation of a COPD within the last 14 days.
• Autoimmune disease (including rheumatoid arthritis), if under immunosuppressive therapy (see below)
• Insulin dependent diabetes mellitus
• Acute or progressive hepatic disease
• Acute or progressive renal disease
• Severe neurological or psychiatric disorder
• 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
• 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:
• 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,
• Receipt of immunostimulants,

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (2)

Betriebsaerztlicher Dienst, Standort Marburg

Baldingerstrasse, Marburg Hessen, 35033, Germany

Location

Z29, Blutspendezentrale, Gebaude Z29, Behringwerke

Emil-von-Behring-Str. 76, Marburg, 35041, Germany

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Posting Director
• Organization: Novartis Vaccines and Diagnostics

RegistryContactVaccinesUS@novartis.com

Study Officials

• Novartis Vaccines

  Novartis Vaccines

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2007
• First Posted: August 6, 2007
• Study Start: July 1, 2007
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: January 24, 2013
• Results First Posted: January 17, 2013

Record last verified: 2013-01

Locations

DE (2)