Trials Sponsors Conditions Drugs Pricing

Conditions

H5N1 Influenza

Keywords

Prophylaxis of influenza infection caused by a pandemic influenza virus (H5N1)

Outcome Measures

Primary Outcomes (3)

Number of subjects with antibody response to the vaccine strain
Measurement by single radial hemolysis (SRH) assay
21 days after 2nd vaccination
Number of subjects demonstrating seroconversion
Measurement by SRH assay
21 days after 2nd vaccination
Fold increase of antibody response
Measurement by SRH assay
21 days after 2nd vaccination

Secondary Outcomes (4)

Number of subjects with antibody response to the vaccine strain
21 days after 1st and 21+180 days after 2nd vaccination
Number of subjects demonstrating seroconversion
21 days after 1st and 21+180 days after 2nd vaccination
Antibody response
21 days after 1st and 21 + 180 days after 2nd vaccination
Fold increase of antibody response
21 days after 1st and 21+180 days after 2nd vaccination as compared to baseline

Study Arms (4)

Treatment group I / Intramuscular

EXPERIMENTAL

85 subjects to receive 2 intramuscular vaccinations at Dose A on Days 1 and 22

Biological: H5N1 (pre-)pandemic influenza vaccine (whole virion, Vero Cell derived, inactivated)

Treatment group II / Intramuscular

EXPERIMENTAL

85 subjects to receive 2 intramuscular vaccinations at Dose B on Days 1 and 22

Biological: H5N1 (pre-)pandemic influenza vaccine (whole virion, Vero Cell derived, inactivated)

Treatment group III / Subcutaneous

EXPERIMENTAL

Interventions

H5N1 (pre-)pandemic influenza vaccine (whole virion, Vero Cell derived, inactivated)Biological

Intramuscular injection into the musculus deltoideus or subcutaneous injection in the upper arm

Treatment group I / IntramuscularTreatment group II / IntramuscularTreatment group III / SubcutaneousTreatment group IV / Subcutaneous

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 59 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Subject is 18 to 59 years old at the time of screening
Subject is generally healthy, as determined by the investigator´s clinical judgement through collection of medical history and performance of a physical examination

Sponsors & Collaborators

Alachua Government Services, Inc.
Industrylead
Baxter Innovations GmbH
Industrycollaborator

Study Sites (3)

Medical Co. LTA PS Clinic

Fukuoka, Fukuoka, 812-0025, Japan

CPC Clinic, Medipolis Medical Research Institute

Kagoshima, Kagoshima-ken, 890-0081, Japan

Osaka Pharmacology Clinical Research Hospital

Osaka, Osaka, 532-0003, Japan

MeSH Terms

Conditions

Influenza in Birds

Condition Hierarchy (Ancestors)

Orthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesInfectionsBird DiseasesAnimal Diseases

Study Officials

Alexander Geisberger, MD
Baxter Innovations GmbH
STUDY DIRECTOR

Enrollment

340 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2 3
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 24, 2011

First Posted

June 27, 2011

Study Start

June 2011

Date type not reported

This date has not been verified as actual or estimated.

You may not qualify if:

Subject has a history of infectin with H5N1 virus or a history of vaccination with an H5N1 influenza vaccine
Subject is at high risk of contracting H5N1 influenza infection (e.g. poultry workers)
Subject currently has or has a history of a significant cardiovascular (including hypertension), respiratory (including asthma), metabolic, neurological (including Guillain-Barré Syndrome and acute disseminated encephalomyelitis), hepatic, rheumatic, autoimmune, hematological, gastrointestinal or renal disorder
Subject has any inherited or acquired immunodeficiency
Subject has a disease or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that can be expected to influence immune response. Such treatment includes, but is not limited to: systemic or inhaled corticosteroids, radiation treatment, or other immunosuppressive or cytotoxic drugs
Subject has a history of severe allergic reactions or anaphylaxis
Subject has a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating
Subject has received a blood transfusion or immunoglobulins within 90 days prior to study entry
Subject has donated blood or plasma within 30 days prior to study entry
Subject has received any influenza or any live vaccine within 4 weeks or any other inactivated vaccine within 2 weeks prior to vaccination in this study
Subject has a functional or surgical asplenia
Subject has a known or suspected problem with alcohol or drug abuse
Subject was administered an investigational drug within 6 weeks prior to study entry or is concurrently participating in a clinical study that includes the administration of an investigational product
Subject is a member of the team conducting this study or is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator/subinvestigator or site personnel conducting the study
If female, subject is pregnant or lactating at the time of enrollment
+1 more criteria

H5N1 Vaccine Study in Japanese Adults

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (4)

Study Arms (4)

Treatment group I / Intramuscular

Treatment group II / Intramuscular

Treatment group III / Subcutaneous

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Treatment group IV / Subcutaneous

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (4)

Study Arms (4)

Treatment group I / Intramuscular

Treatment group II / Intramuscular

Treatment group III / Subcutaneous

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Treatment group IV / Subcutaneous

You may not qualify if:

Source record

Locations