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Safety, Tolerability, and Immunogenicity Study of a Cell-based Virosomal Influenza Vaccine in Healthy Adults

NCT02148328 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2014-10-24

No results posted yet for this study

Summary

The purpose of this study is to examine the safety and tolerability after administration of trivalent and quadrivalent cell-based virosomal influenza vaccine in healthy adults.

Conditions

Interventions

BIOLOGICAL

Trivalent virosomal influenza vaccine

Trivalent virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.

BIOLOGICAL

Commercial vaccine 1

Trivalent commercial virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.

BIOLOGICAL

Quadrivalent virosomal influenza vaccine

Quadrivalent virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.

BIOLOGICAL

Commercial vaccine 2

Quadrivalent commercial influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.

Sponsors & Collaborators

  • Crucell Holland BV

    lead INDUSTRY

Principal Investigators

  • Crucell Holland BV Clinical Trial · Crucell Holland BV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2014-10-31
Completion
2014-10-31

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 NCT02148328 on ClinicalTrials.gov