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

NCT01578070 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2013-08-30

No results posted yet for this study

Summary

The purpose of this study is to show that ViscoGel® is safe when administrated alone and as an adjuvant together with Act-HIB® vaccine in healthy volunteers and to evaluate the quantitative and qualitative effect on the immune response.

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.

Sponsors & Collaborators

  • Karolinska Institutet

    collaborator OTHER

  • Pharma Consulting Group AB

    collaborator INDUSTRY

  • Viscogel AB

    lead INDUSTRY

Principal Investigators

  • Nabil Al-Tawil, MD/PhD · KTA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Sweden

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01578070 on ClinicalTrials.gov