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Safety and Tolerability of a Cell-Derived Influenza Vaccine in Healthy Adults Aged ≥18 Years and ≤ 49 Years

NCT ID: NCT00599443

Last Updated: 2008-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-05-31

Brief Summary

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A controlled, double blinded study to determine the safety and reactogenicity in healthy adults of a single dose of a trivalent cell-derived influenza vaccine administered by intramuscular injection.

Detailed Description

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Conditions

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Healthy

Keywords

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Cell-derived subunit influenza vaccine Safety Reactogenicity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Seasonal cell-derived influenza vaccine

Intervention Type BIOLOGICAL

0.5 mL im, single dose

2

Group Type PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type BIOLOGICAL

0.5 mL im, single dose

Interventions

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Seasonal cell-derived influenza vaccine

0.5 mL im, single dose

Intervention Type BIOLOGICAL

Placebo Comparator

0.5 mL im, single dose

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy female or male subjects aged ≧18 and ≦49 years
* Willing and able to give informed consent

Exclusion Criteria

* Influenza vaccination of laboratory confirmed influenza infection within six months of informed consent,
* presence of any significant medical condition,
* a serious adverse reaction after a previous (influenza) vaccination,
* underlying medical conditions for which annual influenza vaccine is recommended by the Advisory Committee on Immunization Practices (ACIP),
* chronic diseases requiring long-term immunosuppressive therapy
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Solvay Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Solvay Pharmaceuticals

Principal Investigators

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Global Clinical Director Solvay

Role: STUDY_DIRECTOR

Solvay Pharmaceuticals

Other Identifiers

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S203.1.001

Identifier Type: -

Identifier Source: org_study_id