NCT00959465

Brief Summary

The purpose of the study is to obtain immunogenicity and safety data at different dose levels of an investigational H1N1 pandemic influenza vaccine in healthy adults 18 years of age and older.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
408

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2009

Shorter than P25 for phase_1

Geographic Reach
2 countries

5 active sites

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

August 1, 2009

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

October 9, 2015

Status Verified

July 1, 2010

Enrollment Period

3 months

First QC Date

August 13, 2009

Last Update Submit

October 7, 2015

Conditions

InfluenzaPandemic Influenza

Outcome Measures

Primary Outcomes (1)

  • Number of subjects achieving antibody levels to A/H1N1/California/07/2009 virus that meet the definition of seroprotection and seroconversion at 21 days after the second vaccination

    42 days

Study Arms (3)

Cohort 1/Dose Level A

EXPERIMENTAL

Subjects in Cohort 1 will be randomized 1:1 to receive two vaccinations of Dose A or Dose B of H1N1 pandemic influenza vaccine at a 21-day interval.

Biological: H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)

Cohort 1/Dose B

EXPERIMENTAL

Subjects in Cohort 1 will be randomized 1:1 to receive two vaccinations of Dose A or Dose B of H1N1 pandemic influenza vaccine at a 21-day interval.

Biological: H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)

Cohort 2/Dose C

EXPERIMENTAL

A second cohort may be enrolled with all subjects in this cohort receiving two vaccinations of Dose C of H1N1 pandemic influenza vaccine at a 21-day interval.

Biological: H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)

Interventions

H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)BIOLOGICAL

Two injections at a 21-day interval (Days 1 and 22)

Cohort 1/Dose BCohort 1/Dose Level ACohort 2/Dose C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is 18 to 59 years old (age stratum A) or 60 years of age or older (age stratum B) at the time of screening
  • Subject has an understanding of the study, agrees to its provisions, and gives written informed consent prior to study entry
  • Subject is generally healthy, as determined by the investigator's clinical judgment through collection of medical history and the performance of a physical examination
  • Subject is physically and mentally capable of participating in the study and willing to adhere to study procedures to include completion of all elements of the study diary
  • If female of childbearing potential, subject has a negative urine pregnancy test result within 24 hours prior to the scheduled first vaccination and agrees to employ adequate birth control measures for the duration of the study

You may not qualify if:

  • Subject has participated in another clinical study involving an investigational drug, biological product or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an investigational drug, biological or device during the course of this study
  • Subject has a history of exposure to A/H1N1/California/07/2009 virus or a history of vaccination with A/H1N1/California/07/2009 antigen or a closely related influenza virus antigen
  • Subject has inherited or acquired immune deficiency
  • Subject currently has or has a recent history of significant neurological, cardiovascular or pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Sanatorium Leech

Graz, 8010, Austria

Location

ClinPharm International GmbH

Vienna, 1090, Austria

Location

Medical University of Vienna, Institute for Specific Prophylaxis and Tropical Medicine

Vienna, 1090, Austria

Location

University Hospital, Department of Clinical Pharmacology

Vienna, 1090, Austria

Location

Praxis Regner Schmitt

Mainz, 55116, Germany

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Gerald Aichinger, MD

    Baxter Healthcare Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 13, 2009

First Posted

August 14, 2009

Study Start

August 1, 2009

Primary Completion

November 1, 2009

Study Completion

April 1, 2010

Last Updated

October 9, 2015

Record last verified: 2010-07

Locations

DE(1)AU(4)