Safety and Immunogenicity of Surface Antigen, Inactivated, Influenza Vaccine Using the Strain Composition 2009/2010 Recommended in Northern Hemisphere in Non-elderly Adult and in Elderly Subjects

NCT00918268 | Completed Phase 2

• 2 other identifiers: V71_10S2009-010598-19
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 3

Brief Summary

Annual trial for registration influenza vaccine with the strain composition for season 2009/2010.

Conditions

Influenza Disease

Keywords

Influenza vaccine

Outcome Measures

Primary Outcomes (2)

• Evaluation of the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) at 21 days post-immunization in non-elderly adult and elderly subjects

  21(-1/+5) days

• Evaluation of safety of a single intramuscular injection of influenza vaccine in non elderly adult and elderly subjects

  21(-1/+5) days

Study Arms (1)

Influenza vaccine

EXPERIMENTAL

Biological: Influenza vaccine

Interventions

Influenza vaccine BIOLOGICAL

One 0.5mL dose of Inactivated, Influenza Vaccine using the strain composition 2009/2010

Influenza vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older, mentally competent, willing and able to give written informed consent prior to study entry;
• able to comply with all the study requirements;
• in general good health as determined by:medical history, physical examination and- clinical judgment of the investigator Written informed consent must be obtained for all the subjects before enrollment into the study after the nature of the study has been explained.

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 and 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;
• Female who are pregnant or nursing (breastfeeding) mothers or females of childbearing age do not plan to use acceptable birth control measures, for the duration of the study. Adequate contraception is defined as hormonal (e.g., oral, injection, transdermal patch, implant, cervical ring), barrier (e.g., 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;
• Within the past 12 months, they have:- received more than one injection of influenza vaccine

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (3)

Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio, Via dei Vestini

Chieti, 66100, Italy

Location

Ufficio Igiene e Sanità Pubblica di Lanciano, ASL Lanciano - Vasto, sede legale Via S. Spaventa, 37 ----- Satellite sites: (a) Distretto Sanitario di Base, Via Don Minzoni, Lanciano (CH) and (b) Distretto Sanitario di Base, Via Polidoro, Fossacesia (CH))

Lanciano, 66034, Italy

Location

Pianiga Distretto n. 2 - Area Sud - Azienda ULSS 13 Mirano-Via Nazionale 48

Pianiga, 30030, 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: June 9, 2009
• First Posted: June 11, 2009
• Study Start: June 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: April 23, 2012

Record last verified: 2012-04

Locations

IT (3)