Safety and Immunogenicity of One Dose of a Surface, Antigen, Inactivated, Influenza Vaccine Produced in Mammalian Cell Culture Administered to Adult and Elderly Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01422512
First received: August 23, 2011
Last updated: October 10, 2011
Last verified: October 2011
  Purpose

This study will evaluate safety and immunogenicity of surface, antigen, inactivated, influenza vaccine produced in mammalian cell culture when administered to adult and elderly subject.


Condition Intervention Phase
Influenza
Biological: seasonal influenza vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase III Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface, Antigen, Inactivated, Influenza Vaccine Produced in Mammalian Cell Culture, Formulation 2011/2012, When Administered to Adult and Elderly Subjects

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Antibody response as measured by hemagglutination inhibition (HI) assay [ Time Frame: 22 days ] [ Designated as safety issue: No ]
    Antibody response to each influenza antigen as measured by hemagglutination inhibition (HI) at 21 days post-immunization in adult and elderly subjects in complinace with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines


Secondary Outcome Measures:
  • Antibody response as measured by single radial hemolysis (SRH) assay [ Time Frame: 22 days ] [ Designated as safety issue: No ]
    Antibody response to each influenza antigen as measured by single radial hemolysis (SRH) at 21 days post-immunization in adult and elderly subjects in complinace with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines

  • Number of subjects with solicited local and systemic reactions [ Time Frame: 7 days post vaccination ] [ Designated as safety issue: Yes ]
    To evaluate the safety of a single intramuscular (IM) injection of Optaflu in adult and elderly subjects in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines (CPMP/BWP/214/96)


Enrollment: 126
Study Start Date: September 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cell culture derived TIV
single dose of cell culture derived seasonal trivalent influenza vaccine (TIV)
Biological: seasonal influenza vaccine
Subjects received one single IM dose of trivalent Surface, Antigen, Inactivated, Influenza Vaccine Produced in Mammalian Cell Culture during the vaccination visit, according to the study protocol (follow-up period: until day 22) .
Other Name: Optaflu

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Males and female volunteers of 18 years of age or older, mentally competent, willing and able to give written informed consent prior to study entry
  2. Individuals able to comply with all the study requirements
  3. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator

Exclusion Criteria:

  1. Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study
  2. Individuals with any serious chronic or acute disease including but not limited to: Medically significant Cancer , Medically significant advanced congestive heart failure (ie. NYHA class III and IV),Chronic obstructive pulmonary disease (COPD); Autoimmune disease (including rheumatoid arthritis, except for Hashimoto's thyroiditis that has been clinically stable for ≥ 5 years);Diabetes mellitus type I/II ;Advanced arteriosclerotic disease ;History of underlying medical condition such as major congenital abnormalities requiring surgery, chronic treatment, or associated with developmental delay (e.g., Down's syndrome);Acute or progressive hepatic disease; Acute or progressive renal disease; Severe neurological or psychiatric disorder; Severe asthma
  3. Individuals with history of any anaphylactic reaction and/or serious allergic reaction following a vaccination
  4. Individuals with known or suspected impairment/alteration of immune function resulting, for example, from:

    receipt of immunosuppressive therapy (any parenteral or oral corticosteroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study; receipt of immunostimulants; receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study; suspected or known HIV infection or HIV-related disease

  5. Individuals with known or suspected history of drug or alcohol abuse
  6. Individuals with a bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject
  7. Female who are pregnant or nursing (breastfeeding) mothers or females of childbearing potential not planning to use acceptable birth control measures, for the whole duration of the study
  8. Individuals with history or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study
  9. Individuals who within the past 6 months have had any seasonal or pandemic laboratory confirmed influenza disease
  10. Individuals who have received any seasonal or pandemic influenza vaccine;
  11. Individuals with any acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days
  12. Individuals who have experienced fever (i.e., axillary temperature ≥ 38°C) within the last 3 days of intended study vaccination
  13. Individuals participating in another clinical trial
  14. Individuals who have ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks and for the full length of the study
  15. Individuals who are part of study personnel or close family members conducting this study
  16. BMI > 35 kg/m2
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01422512

Locations
Germany
Universität Rostock / Medizinische Fakultät
Rostock, Germany, 18057
Sponsors and Collaborators
Novartis Vaccines
Investigators
Principal Investigator: Prof. Reisinger Universität Rostock / Medizinische Fakultät
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01422512     History of Changes
Other Study ID Numbers: V58_25S, 2010-024613-31
Study First Received: August 23, 2011
Last Updated: October 10, 2011
Health Authority: European Union: European Medicines Agency

Keywords provided by Novartis:
seasonal influenza
vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 18, 2014