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

NCT00748813 | Completed Phase 2

• 2 other identifiers: V71P7S2008-001079-31
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Seasonal Influenza

Keywords

Influenza vaccine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluation of safety

  21 days (-1/+5)

Study Arms (1)

1

OTHER

Biological: Influenza Vaccine, Formulation 2008-2009

Interventions

Influenza Vaccine, Formulation 2008-2009 BIOLOGICAL

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

1

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 are:
• ≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry
• able to comply with all study requirements
• in good health as determined by:
• medical history
• physical examination
• clinical judgment of the investigator

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (3)

Site 1

Chieti, 66100, Italy

Location

Site 2

Lanciano, 66034, Italy

Location

Site 3

Pianiga, 30034, Italy

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Novartis Vaccines

  Novartis Vaccines

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2008
• First Posted: September 9, 2008
• Study Start: June 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: December 1, 2016

Record last verified: 2011-12

Locations

IT (3)