A Phase III, Observer-Blind, Randomized, Multi-Center Study to Evaluate Safety, Tolerability and Immunogenicity (in a Subset) Following a Single Intramuscular Dose of a Trivalent Subunit Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs, in Healthy Adult and Elderly Subjects Who Received Either One or the Other Vaccine One Year Before in the V58P4 Study.

Novartis Vaccines5 sites in 1 country2,235 target enrollmentSeptember 2005

ConditionsInfluenza

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Influenza
Sponsor: Novartis Vaccines
Enrollment: 2235
Locations: 5
Primary Endpoint: Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to evaluate safety, tolerability and immunogenicity (in a subset) following a dose of a trivalent subunit influenza vaccine produced either in mammalian cells or in embryonated hen eggs, in healthy adult and elderly subjects who received either vaccine one year before (2004) in the study V58P4.

Registry

clinicaltrials.gov

Start Date

September 2005

End Date

April 2006

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Novartis Vaccines

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•18 to \< 61 years of age (first age group) OR 61 years of age and older (second age group) at enrolment in V58P4
•Mentally competent to understand the nature, the scope and the consequences of the study
•Able and willing to give written informed consent prior to study entry
•Available for all the visits scheduled in the study
•in good health as determined by:
•Medical history related to the previous six months,
•Physical examination,
•Clinical judgment of the investigator.

Exclusion Criteria

•Unwilling or unable to give written informed consent to participate in the study
•Currently experiencing an acute infectious disease
•Any serious disease such as, for example:
•Cancer (except for benign or localized skin cancer and non metastatic prostate cancer not currently treated with chemotherapy)
•Autoimmune disease (including rheumatoid arthritis)
•Advanced arteriosclerotic disease or complicated diabetes mellitus
•Chronic obstructive pulmonary disease (COPD) requiring oxygen therapy
•Acute or progressive hepatic disease
•Acute or progressive renal disease
•Congestive heart failure

Outcomes

Primary Outcomes

Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine

Time Frame: Day 1 to Day 7 postvaccination

To assess the safety and tolerability in terms of number of adult and elderly subjects reporting solicited adverse events following one dose of the cTIV or the TIV vaccine .

Secondary Outcomes

Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine(Up to 6 months postvaccination)
Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects(Day 22 postvaccination)
Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects(Day 22 postvaccination)
Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine.(Day 22 postvaccination)
Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine.(Day 22 postvaccination)