Safety and Immunogenicity of Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2008-2009, When Administered to Non-Elderly Adult and Elderly Subjects

NCT00748150 | Completed Phase 2

• 2 other identifiers: V78P6S2008-000939-17
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Influenza

Keywords

flu; influenza; influenza vaccine antigen; immunogenicity; antibody response; intra muscular; elderly; non-elderly

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Evaluation of safety of the influenza vaccine

  21 days

Study Arms (1)

1

EXPERIMENTAL

Biological: Flu Vaccine Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2008-2009

Interventions

Flu Vaccine Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2008-2009 BIOLOGICAL

1 dose, 0.5 mL of Flu Vaccine Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, 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:

• ≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry
• available for all the visits scheduled in the study and 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:

• Any serious (in the judgment of the investigator) disease 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
• 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, polymixin)
• 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 derivatives 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 (1)

The Health Centre

Heath Road, Woolpit, Bury Saint Edmunds, Suffolk, IP309QU, United Kingdom

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Antigens, Surface

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antigens; Biological Factors

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 5, 2008
• First Posted: September 8, 2008
• Study Start: July 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: January 5, 2012

Record last verified: 2012-01

Locations

GB (1)