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Efficacy Study of Two Influenza Vaccines and Placebo in Healthy Adult Subjects

NCT00630331 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 11404

Last updated 2024-05-24

Study results available
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Summary

The present study will evaluate clinical efficacy, safety, tolerability and immunogenicity of both Novartis Vaccines' cell-derived influenza vaccine and egg-derived influenza vaccine in healthy adults 18 to 49 years of age.

Conditions

Interventions

BIOLOGICAL

Cell culture-derived influenza vaccine

One dose (0.5 mL) of cell culture-derived influenza vaccine, administered in the deltoid muscle.

BIOLOGICAL

Egg-derived influenza virus vaccine

One dose (0.5 mL) of the trivalent egg-derived influenza virus vaccine, administered in the deltoid muscle.

BIOLOGICAL

Placebo

One dose (0.5 mL) of phosphate buffered solution.

Sponsors & Collaborators

  • Novartis Vaccines

    lead INDUSTRY

Principal Investigators

  • Novartis Vaccines · Novartis Vaccines

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • United States
  • Finland
  • Poland

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00630331 on ClinicalTrials.gov