Clinical Trials Logo

Clinical Trial Summary

This is a Phase 1/2, randomized, observer-blind, placebo-controlled clinical trial. A maximum of 500 eligible subjects in 10 groups will be enrolled, randomized and vaccinated in this study. Subjects will receive an intramuscular injection of either the influenza A/H5N1 (low, medium or high dose) or placebo on Day 0 and Day 21 with or without a patch. This study will be performed in two parts.

In Part 1, an initial safety evaluation will be performed in 100 randomized subjects. A Safety Review Committee (SRC)will review all safety data, including laboratory values, through the Day 7 visit, and compare those data against Stopping Criteria. If the treatments are considered safe, Part 2 of the study will be initiated and a second vaccination will be administered to subjects in Part 1 on Day 21.

In Part 2, the remaining 400 subjects will be randomized, treated, and will follow the same visit structure and protocol-defined requirements as subjects in Part 1, without the additional laboratory safety measurements. An SRC review will also be performed of all safety data through the Day 28 visit for subjects participating in Part 1.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00532792
Study type Interventional
Source Intercell USA, Inc.
Contact
Status Completed
Phase Phase 1
Start date August 2007
Completion date June 2008

See also
  Status Clinical Trial Phase
Completed NCT00971542 - Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin A/H1N1 Monovalent Influenza Vaccine (Egg-Derived) in Healthy Subjects From 6 Months to 17 Years of Age Phase 3
Completed NCT00976469 - A/H1N1 Immunogenicity and Safety in Infants, Children and Adolescents Phase 1/Phase 2
Completed NCT00535665 - Safety and Immunogenicity of an Inactivated Pandemic Influenza Vaccine Phase 2
Completed NCT00950456 - Observational Study to Assess Safety of H1N1 Pandemic Influenza Vaccine N/A
Completed NCT00908687 - A/H5N1/LT Dose Ranging Study Phase 2
Completed NCT00783926 - Phase 1 Study of a H5N1 Influenza Vaccine (Reverse Genetic Reassortant) Phase 1
Completed NCT00519389 - Safety, Reactogenicity and Immunogenicity of an H5N1 VLP Phase 1/Phase 2
Recruiting NCT06046092 - H7HLAII DNA Influenza Vaccine Phase 1
Completed NCT01640691 - Immunogenicity and Safety of Pandemic Influenza Vaccine in Healthy Adults Phase 1/Phase 2
Completed NCT01053143 - Study of Swine-Origin A/H1N1 Influenza Non-Adjuvanted Vaccine in Healthy Adults in India Phase 3
Completed NCT00457509 - Safety and Immunogenicity of H5N1 Adjuvanted, Inactivated, Split-Virion Pandemic Influenza Vaccine in Healthy Adults Phase 1
Completed NCT00660257 - Safety and Immunogenicity of Booster Dose of An Inactivated,Adjuvanted Whole-Virion Pandemic Influenza(H5N1)Vaccine Phase 1
Completed NCT00959465 - A/H1N1 Immunogenicity and Safety in Adults Phase 1/Phase 2
Completed NCT00971906 - Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin A/H1N1 Monovalent Influenza Vaccine in Healthy Subjects 18 or More Years of Age Phase 3
Completed NCT00971100 - Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin A/H1N1 Monovalent Influenza Vaccine in Healthy Subjects From 6 Months to 17 Years of Age Phase 3
Completed NCT00970177 - Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin A/H1N1 Monovalent Influenza Vaccine in Healthy Subjects 18 or More Years of Age Phase 3
Withdrawn NCT00640874 - A Prospective Study to Examine the Effectiveness and Safety of Antivirals in Volunteers Who Receive Short-term Prophylaxis Against Pandemic Influenza N/A
Withdrawn NCT00640211 - A Prospective Study to Examine the Effectiveness and Safety of Neuraminidase Inhibitors in Volunteers Who Receive Long-term Prophylaxis Against Pandemic Influenza: PIPET B N/A
Withdrawn NCT00640302 - A Prospective Study to Examine the Effectiveness and Safety of Neuraminidase Inhibitors in Index Cases With Presumed Pandemic Influenza N/A