NCT01006798 - Safety and Immunogenicity of Replication-Competent Adenovirus 4-vectored Vaccine for Avian Influenza H5N1 | Biotech Hunter

Enrollment

166

Participants

Timeline

Start Date

October 31, 2009

Primary Completion Date

September 30, 2011

Study Completion Date

September 30, 2011

Conditions

Bird FluInfluenza

Interventions

OTHER

Placebo

enteric coated capsule containing no vaccine virus

BIOLOGICAL

Ad4-H5-Vtn

a live, replication-competent, recombinant Ad4 virus expressing the HA of H5N1 influenza (A/Vietnam/1194/2004) in an enteric capsule for oral administration

BIOLOGICAL

Sanofi Pasteur Influenza Virus Vaccine, H5N1

Single administration of a heterologous boost given to volunteers 3 to 15 months following their last vaccination with Ad4-H5-Vtn or placebo.

Trial Locations (4)

14642

University of Rochester, Rochester

29464

Coastal Carolina Research Center, Inc., Mt. Pleasant

40536

University of Kentucky, Lexington

64114

The Center for Pharmaceutical Research, Kansas City