NCT00532792View on ClinicalTrials.gov

A/H5N1 Dose Ranging Study With Adjuvant Patch

PHASE1CompletedINTERVENTIONAL
Enrollment

501

Participants

Timeline

Start Date

August 31, 2007

Primary Completion Date

June 30, 2008

Study Completion Date

June 30, 2008

Conditions
Pandemic Influenza
Interventions
BIOLOGICAL

A/H5N1

Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; No LT Patch Day 0 or Day 21

BIOLOGICAL

A/H5N1

Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21

BIOLOGICAL

A/H5N1

Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21

BIOLOGICAL

A/H5N1

Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21

BIOLOGICAL

A/H5N1

Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21

BIOLOGICAL

A/H5N1

Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21

BIOLOGICAL

A/H5N1

High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21

BIOLOGICAL

A/H5N1

High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21

BIOLOGICAL

A/H5N1

High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21

BIOLOGICAL

Placebo

Placebo (0.5ml); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21

Trial Locations (5)

33143

Miami Research Associates, Miami

66211

Quintiles Phase One Services, Kansas City

84124

Jean Brown Research, Salt Lake City

94589

Solano Clinical Research, Vallejo

98418

Northwest Kinetics, Tacoma

All Listed Sponsors
collaborator

Department of Health and Human Services

FED

lead

Intercell USA, Inc.

INDUSTRY

NCT00532792 - A/H5N1 Dose Ranging Study With Adjuvant Patch | Biotech Hunter | Biotech Hunter