Safety and Immunogenicity, Inactivated Split Influenza Vaccine, Using the Strain Composition 2009/2010

A Phase III, Multicenter, Uncontrolled, Open-label Study to Evaluate Safety and Immunogenicity of a Preservative Free, Inactivated Split Influenza Vaccine, Using the Strain Composition 2009/2010 When Administered to Adult and Elderly Subjects

This study is an annual trial for registration of inactivated split influenza vaccine with strain composition for season 2009/2010.

Study Overview

• Status: Completed
• Conditions: Seasonal Influenza
• Intervention / Treatment: Biological: inactivated split influenza vaccine

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Giessen, Germany, 35392
    • Site 2
  • Herborn, Germany, 35745
    • Site 1
  • Marburg, Germany, 35033
    • Site 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

1. ≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry
2. Able to comply with all study requirements

3. In good health as determined by:

   • Medical history;
   • Physical examination;
   • Clinical judgment of the investigator. Informed consent must be obtained for all the subjects before enrollment into the study after the nature of the study has been explained.

Exclusion Criteria:

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

1. They have any serious chronic or acute disease (in the judgment of the investigator) including but not limited to:

   • Cancer, except for localized skin cancer;
   • Advanced congestive heart failure;
   • Chronic obstructive pulmonary disease (COPD);
   • Autoimmune disease (including rheumatoid arthritis);
   • Acute or progressive hepatic disease;
   • Acute or progressive renal disease;
   • Severe neurological or psychiatric disorder;
   • Severe Asthma.
2. History of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g., to ovalbumin, chicken protein, chicken feathers, influenza viral protein neomycin or polymyxin).

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:

   • Receipt of immunosuppressive therapy (any parental or oral cortical steroid 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 derivatives within the past 3 months and for the full length of the study.
   • Suspected or known HIV infection or HIV-related disease.
4. Known or suspected history of drug or alcohol abuse.
5. They have a bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject;
6. Women who are pregnant or woman of childbearing potential unwilling to practice acceptable contraception for the duration of the study (21 days). Female who pregnant of nursing (breastfeeding) mothers of females of childbearing age who do not plan to use acceptable birth control measures, for the duration of the study. Adequate contraception is defined as hormonal (oral, injection, transdermal patch, implant, cervical ring), barrier (condom or diaphragm), intrauterine device (IUD) or monogamous relationship with vasectomized partner who has been vasectomized for 6 months or more prior to the subject's study entry.
7. Influenza vaccination or laboratory confirmed influenza within the last 6 months and more than one influenza vaccination within the past 12 months.

8. Within the past 4 weeks they have received:

   • Another vaccine;
   • Any investigational agent.
9. Any acute or chronic infection requiring systemic antibiotic treatment or antiviral therapy within the last 7 days.
10. They have experienced fever (i.e., axillary temperature ≥ 38°C) within the last 3 days.
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.
13. Severely obese with Body Mass Index (BMI) > 35.
14. Site personnel involved in evaluation of safety and their immediate relatives are excluded from participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 1	Biological: inactivated split influenza vaccine; 1 dose of inactivated split influenza vaccine, using the strain composition 2009/2010

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of antibody response to each influenza vaccine antigen, as measured by haemagglutination inhibition (HI) test on Day 0 and on Day 21	21 days (-1/+7)
Evaluation of safety of inactivated split influenza vaccine	21 days (-1/+7)

Collaborators and Investigators

• Sponsor: Novartis
• Collaborators: Novartis Vaccines

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: July 22, 2009
• First Submitted That Met QC Criteria: July 23, 2009
• First Posted (Estimate): July 24, 2009

Study Record Updates

• Last Update Posted (Actual): April 7, 2017
• Last Update Submitted That Met QC Criteria: April 5, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: vaccine; influenza vaccine
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: V44_13S; 2009-010565-23