NCT01578070View on ClinicalTrials.gov

Single-center Study Evaluating the Safety and Efficacy of Viscogel® as Adjuvant in Act-HIB® Vaccine

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

130

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

December 31, 2012

Study Completion Date

December 31, 2012

Conditions
Healthy
Interventions
BIOLOGICAL

0.2μg Act-HIB®

0.2μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.

BIOLOGICAL

ViscoGel® and 0.2μg Act-HIB®

Pre-selected dose of ViscoGel® (from phase A) and Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.

BIOLOGICAL

ViscoGel® and 2μg Act-HIB®

Pre-selected dose of ViscoGel® (from phase A) and 2μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.

BIOLOGICAL

2μg Act-HIB®

2μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.

BIOLOGICAL

10μg Act-HIB®

Clinical standard dose of 10μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.

Trial Locations (1)

SE-141 86

Karolinska Trial Alliance, Stockholm

Sponsors
All Listed Sponsors
collaborator

Karolinska Institutet

OTHER

collaborator

Pharma Consulting Group AB

INDUSTRY

lead

Viscogel AB

INDUSTRY

NCT01578070 - Single-center Study Evaluating the Safety and Efficacy of Viscogel® as Adjuvant in Act-HIB® Vaccine | Biotech Hunter | Biotech Hunter