Safety and Immunogenicity of Influenza Vaccine (Surface Antigen, Inactivated) [Ph.Eur], Formulation 2009-2010, When Administered to Non-Elderly Adult and Elderly Subjects

NCT00956449 | Completed Phase 2

• 2 other identifiers: V78_07S2009-011004-33
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine, as measured by hemagglutination inhibition (HI) at 21 days post immunization in non-elderly and elderly subjects in compliance with the requirements of the current European Union (EU) recommendations for the evaluation of the immunogenicity for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96).

Conditions

Influenza; Seasonal Influenza

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Immunogenicity and tolerability of the Flu vaccines is being measured

  2 - 21 days

Secondary Outcomes (1)

• To evaluate safety of a single IM (intramuscular) dose of the subunit vaccine of Influenza Vaccine Surface Antigen, Inactivated of Influenza Vaccine

  21 days

Study Arms (1)

1

EXPERIMENTAL

Biological: Seasonal Influenza Vaccine

Interventions

Seasonal Influenza Vaccine BIOLOGICAL

1 dose of Influenza Vaccine Surface Antigen, Inactivated

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:

• Subjects are not to be enrolled into the study if at least one of the following criteria is fulfilled:
• 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
• 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 eggs, chicken protein, chicken feathers, influenza viral protein neomycin or polymyxin).
• 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 parental or oral cortical steroid 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,

Sponsors & Collaborators

• Novartis: lead
• Novartis Vaccines: collaborator

Study Sites (1)

The Health Centre

Suffolk, IP309QU, United Kingdom

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

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

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

Study Record Dates

• First Submitted: August 8, 2009
• First Posted: August 11, 2009
• Study Start: June 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: March 28, 2017

Record last verified: 2017-03

Locations

GB (1)