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Clinical Study for Safety and Immunogenicity Study of Influenza Vaccine

NCT01617239 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2014-08-20

No results posted yet for this study

Summary

The goal of the study is to assess the safety and immune response after vaccination with different doses and vaccination schedules of virosomal influenza vaccine.

Conditions

Interventions

BIOLOGICAL

Virosomal influenza vaccine

Virosomal influenza vaccine with the recommended vaccine composition for season 2011-2012: * 15 μg HA antigen of A/California/7/2009 (H1N1)-like virus * 15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus * 15 μg HA antigen of B/Brisbane/60/2008-like virus Intramuscular (i.m.) administration (M. deltoideus or M. vastus lateralis)

Sponsors & Collaborators

  • Crucell Holland BV

    lead INDUSTRY

Principal Investigators

  • Enza di Modugno · Crucell Holland

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-06-30
Completion
2013-12-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

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 NCT01617239 on ClinicalTrials.gov