NCT00599443

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Oct 2007

Typical duration for phase_1 healthy

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

October 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 23, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

June 30, 2008

Status Verified

June 1, 2008

Enrollment Period

7 months

First QC Date

January 10, 2008

Last Update Submit

June 27, 2008

Conditions

Healthy

Keywords

Cell-derived subunit influenza vaccineSafetyReactogenicity

Outcome Measures

Primary Outcomes (2)

  • Safety and tolerability of one dose of cell-derived influenza vaccine in healthy adults aged ≧18 years and ≦ 49 years after vaccination.

    3 weeks

  • Long-term safety

    6 months

Secondary Outcomes (1)

  • HI antibody titers

    3 weeks

Study Arms (2)

1

EXPERIMENTAL
Biological: Seasonal cell-derived influenza vaccine

2

PLACEBO COMPARATOR
Biological: Placebo Comparator

Interventions

Seasonal cell-derived influenza vaccineBIOLOGICAL

0.5 mL im, single dose

1
Placebo ComparatorBIOLOGICAL

0.5 mL im, single dose

2

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Global Clinical Director Solvay

    Solvay Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 10, 2008

First Posted

January 23, 2008

Study Start

October 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

June 30, 2008

Record last verified: 2008-06