Who is sponsoring NCT01006798?

NCT01006798 is sponsored by Emergent BioSolutions.

What condition does NCT01006798 study?

NCT01006798 studies Bird Flu, Influenza.

What drugs are being tested in NCT01006798?

Interventions: Placebo, Ad4-H5-Vtn, Sanofi Pasteur Influenza Virus Vaccine, H5N1.

What is the status of NCT01006798?

NCT01006798 is currently COMPLETED.

Last reviewed 2024-03-15 · How we verify

Phase 1 Evaluation of the Safety and Immunogenicity of a Replication-Competent Adenovirus Serotype 4-vectored H5N1 Influenza Candidate Vaccine - Ad4-H5-Vtn

NCT01006798 Phase 1 COMPLETED

The purpose of this study is to compare the safety and immunogenicity over a 9-month period of five different dosages of Ad4-H5-Vtn in volunteers (Vaccinees) who receive three doses of the study vaccine or placebo. In addition, transmission of Ad4-H5-Vtn will be evaluated in all Household Contacts residing with the vaccinated volunteers. Vaccinees also may participate in a substudy in which they receive a booster vaccination with the licensed Influenza Virus Vaccine, H5N1 (Sanofi Pasteur).

Details

Lead sponsor	Emergent BioSolutions
Phase	Phase 1
Status	COMPLETED
Enrolment	166
Start date	2009-10
Completion	2011-09

Conditions

Bird Flu
Influenza

Interventions

Placebo
Ad4-H5-Vtn
Sanofi Pasteur Influenza Virus Vaccine, H5N1

Primary outcomes

Safety, defined as the frequency and severity of vaccine-related reactogenicity events and reported AEs — Throughout trial (reactogenicity for 7 days following each vaccination)
Immunogenicity (humoral) defined by H5 HAI titer — At all available timepoints

Countries

United States