Safety and Immunogenicity, Inactivated Split Influenza Vaccine, Using the Strain Composition 2009/2010

NCT00945841 | Completed Phase 3

• 2 other identifiers: V44_13S2009-010565-23
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 3

Brief Summary

This study is an annual trial for registration of inactivated split influenza vaccine with strain composition for season 2009/2010.

Conditions

Seasonal Influenza

Keywords

influenza vaccine; vaccine

Outcome Measures

Primary Outcomes (2)

• 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 (-1/+7)

• Evaluation of safety of inactivated split influenza vaccine

  21 days (-1/+7)

Study Arms (1)

1

OTHER

Biological: inactivated split influenza vaccine

Interventions

inactivated split influenza vaccine BIOLOGICAL

1 dose of inactivated split influenza vaccine, using the strain composition 2009/2010

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. 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:

• 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 ovalbumin, 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 (3)

Site 2

Giessen, 35392, Germany

Location

Site 1

Herborn, 35745, Germany

Location

Site 3

Marburg, 35033, Germany

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 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 22, 2009
• First Posted: July 24, 2009
• Study Start: June 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: April 7, 2017

Record last verified: 2017-04

Locations

DE (3)