Safety and Immunogenicity of Surface Antigen, Inactivated, Influenza Vaccine Using the Strain Composition 2008/2009

A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2008-2009, When Administered to Non-Elderly Adult and Elderly Sub

Annual trial for registration influenza vaccine with the strain composition for season 2008/2009

Study Overview

• Status: Completed
• Conditions: Seasonal Influenza
• Intervention / Treatment: Biological: Influenza Vaccine, Formulation 2008-2009

• Study Type: Interventional
• Enrollment (Actual): 133
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • Chieti, Italy, 66100
    • Site 1
  • Lanciano, Italy, 66034
    • Site 2
  • Pianiga, Italy, 30034
    • Site 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• 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

Exclusion Criteria:

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

  1. Cancer, except for localized skin cancer;
  2. Advanced congestive heart failure;
  3. Chronic obstructive pulmonary disease (COPD);
  4. Autoimmune disease (including rheumatoid arthritis);
  5. Acute or progressive hepatic disease;
  6. Acute or progressive renal disease;
  7. Severe neurological or psychiatric disorder;
  8. Severe asthma.
• They have 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, kanamycin and neomycin sulphate);
• They have a 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 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;
• They have a known or suspected history of drug or alcohol abuse;
• They have a bleeding diathesis or condition associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject;
• Women who are pregnant, or women able to bear children but not willing to practice acceptable contraception for the duration of the trial (21 days);
• Within the past 12 months, they have:
• received more than one injection of influenza vaccine
• Within the past 6 months, they have:
• had laboratory confirmed influenza disease;
• received influenza vaccine;
• Within the past 4 weeks they have received:
• another vaccine;
• any investigational agent;
• They have any acute or chronic infection requiring systemic antibiotic treatment or antiviral therapy within the last 7 days; 1 - They have experienced an acute exacerbation of a COPD within the past 14 days

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-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: Influenza Vaccine, Formulation 2008-2009; 1 dose of Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2008-2009

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) test on Day 0 and on Day 21	21 days (-1/+5)

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluation of safety	21 days (-1/+5)

Collaborators and Investigators

• Sponsor: Novartis Vaccines

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: September 8, 2008
• First Submitted That Met QC Criteria: September 8, 2008
• First Posted (Estimate): September 9, 2008

Study Record Updates

• Last Update Posted (Estimate): December 1, 2016
• Last Update Submitted That Met QC Criteria: November 30, 2016
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: 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: V71P7S; 2008-001079-31