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Comparison of the Safety and Immune Response of an Influenza Vaccine Made by a New Manufacturing Process With a Vaccine Made by the Traditional Manufacturing Process for Season 2003/2004

NCT00161837 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2015-10-09

No results posted yet for this study

Summary

The objectives of the study are to assess the immunogenicity and safety of the inactivated influenza vaccine (whole virion, Vero cell-derived) at Day 21 and Day 180 after vaccination.

Conditions

Interventions

BIOLOGICAL

Vero Cell-derived Influenza Vaccine

BIOLOGICAL

Egg-derived Influenza Vaccine

Sponsors & Collaborators

  • Alachua Government Services, Inc.

    lead INDUSTRY

Principal Investigators

  • Jerzy Romaszko, MD · PANTAMED sp. z o o.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-12-31
Completion
2004-07-31

Countries

  • Poland

Study Locations

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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 NCT00161837 on ClinicalTrials.gov