Comparative Trial Evaluating Safety and Immunogenicity of an Adjuvanted and a Conventional Influenza Vaccine in Elderly Subjects (> 60 Years)

Part 1:Phase I Open-Label, Single-Center to Evaluate the Safety of a Commercially Available 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 a Commercially Available Influenza Vaccine and a Conventional Commercially Available Influenza Vaccine When Administered to Elderly Subjects

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00310648

Enrollment

600

Registered

2006-04-04

Start date

2006-01-31

Completion date

Unknown

Last updated

2006-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

Influenza, elderly, vaccine

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.

Interventions

BIOLOGICALInfluenza vaccine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Inclusion criteria

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

Exclusion criteria

* 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).

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Solicited Local and Systemic Reactions Within 6 Days Following Vaccination And Adverse Events Thought the Study.	—

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026