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Study to Evaluate the Consistency of Three Consecutive Production Lots of Influenza Vaccine in Healthy Subjects 18 to 49 Years Old

NCT00617851 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1507

Last updated 2012-05-08

Study results available
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Summary

The purpose of this research is to demonstrate immunologic equivalence of three consecutive production lots of the subunit influenza vaccine compared to egg-derived inactivated influenza vaccine in healthy subjects 18 to 49 years of ages. In addition, this study is to show how safe and well tolerated a conventional inactivated subunit influenza vaccine, licensed in many countries outside the United States, is compared to an inactivated influenza vaccine, licensed in the United States.

Conditions

Interventions

BIOLOGICAL

Lot A of Influenza virus vaccine

1 injection of the trivalent subunit influenza virus vaccine (lot A) administered intramuscularly

BIOLOGICAL

Lot B of Influenza virus vaccine

1 injection of the trivalent subunit influenza virus vaccine (lot B) administered intramuscularly

BIOLOGICAL

Lot C of Influenza virus vaccine

1 injection of the trivalent subunit influenza virus vaccine (lot C) administered intramuscularly

BIOLOGICAL

Comparator influenza virus vaccine

1 injection of the trivalent subunit influenza virus vaccine administered intramuscularly

BIOLOGICAL

All 3 consecutive lots of influenza virus vaccine pooled

1 injection of the pooled trivalent subunit influenza virus vaccine administered intramuscularly

Sponsors & Collaborators

  • Novartis Vaccines

    lead INDUSTRY

Principal Investigators

  • Novartis Vaccines and Diagnostics · Novartis

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2007-12-31
Completion
2008-06-30

Countries

  • Dominican Republic

Study Locations

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 NCT00617851 on ClinicalTrials.gov