MedTrace Logo

Comparison of Safety, Tolerability and Immunogenicity of Influenza Vaccines in Adults and Elderly

NCT00306527 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2235

Last updated 2019-08-14

Study results available
· View outcomes & findings →

Summary

The purpose of the study is to evaluate safety, tolerability and immunogenicity (in a subset) following a dose of a trivalent subunit influenza vaccine produced either in mammalian cells or in embryonated hen eggs, in healthy adult and elderly subjects who received either vaccine one year before (2004) in the study V58P4.

Conditions

Interventions

BIOLOGICAL

Cell culture derived influenza vaccine

as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm

BIOLOGICAL

egg-derived influenza subunit vaccine

as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm

Sponsors & Collaborators

  • Novartis Vaccines and Diagnostics S.r.l.

    collaborator UNKNOWN

  • Novartis Vaccines

    lead INDUSTRY

Principal Investigators

  • Novartis Vaccines and Diagnostics · Novartis Vaccines

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2005-12-31
Completion
2006-04-30

Countries

  • Poland

More Related Trials

Entities

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 NCT00306527 on ClinicalTrials.gov