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

Seasonal Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00748813
• Other study ID #: V71P7S
• Secondary ID: 2008-001079-31
• Status: Completed
• Phase: Phase 2
• First received: September 8, 2008
• Last updated: November 30, 2016
• Start date: June 2008
• Est. completion date: July 2008

Study information

• Verified date: December 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministero della Salute, EMEA
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza, Human
• Seasonal Influenza

Intervention

Biological:
• Influenza Vaccine, Formulation 2008-2009
1 dose of Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2008-2009

Locations

Country	Name	City	State
Italy	Site 1	Chieti
Italy	Site 2	Lanciano
Italy	Site 3	Pianiga

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Evaluation of safety		21 days (-1/+5)	Yes

External Links

•   Results for V71P7S from the Novartis Clinical Trials website