NCT00310648

Brief Summary

Clinical Trial in Two parts: Part 1: Phase I, Open-Label, Single-Center Study to Evaluate the Safety of an adjuvanted Influenza Vaccine When Administered to Elderly Subjects. Part 2: A Phase III, Randomized, Controlled, Observer-blind, Single-Center Study to Evaluate the Immunogenicity and Safety of an adjuvanted and a conventional Influenza Vaccine When Administered to Elderly Subjects.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 4, 2006

Completed
Last Updated

September 14, 2006

Status Verified

September 1, 2006

First QC Date

April 3, 2006

Last Update Submit

September 13, 2006

Conditions

Influenza

Keywords

Influenza, elderly, vaccine

Outcome Measures

Primary Outcomes (1)

  • Requirements For Drug Registration & Guide Principles For ClinicaL Trial Techniques of Vaccine e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination.

Secondary Outcomes (1)

  • Solicited Local and Systemic Reactions Within 6 Days Following Vaccination And Adverse Events Thought the Study.

Interventions

Influenza vaccineBIOLOGICAL

Eligibility Criteria

Age60 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects 60 years of age or older, mentally competent, willing and able to give the written informed consent prior to study entry

You may not qualify if:

  • Any serious disease such as: cancer, autoimmune disease, advanced arteriosclerotic disease or complicated diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure.
  • Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine.
  • History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine.
  • Known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanning

Guangxi, 530021, China

Location

Related Publications (1)

  • Li R, Fang H, Li Y, Liu Y, Pellegrini M, Podda A. Safety and immunogenicity of an MF59-adjuvanted subunit influenza vaccine in elderly Chinese subjects. Immun Ageing. 2008 Feb 20;5:2. doi: 10.1186/1742-4933-5-2.

    PMID: 18289372DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Novartis Vaccines - Drug Information Services

    Novartis Vaccines & Diagnostics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 3, 2006

First Posted

April 4, 2006

Study Start

January 1, 2006

Last Updated

September 14, 2006

Record last verified: 2006-09

Locations

CN(1)