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A Study to Assess Immunogenicity Parameters After Vaccination Against Influenza and to Evaluate How These Parameters Change During the Influenza Season

NCT01457027 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2013-02-20

No results posted yet for this study

Summary

A study to evaluate the humoral immune response 3 weeks after vaccination with Inflexal V according to the CHMP criteria in elderly subjects for the 2011/2012 WHO recommended vaccine strains, to evaluate immunogenicity parameters 6 months after vaccination for the 3 vaccine strains and to assess the cross-protection against 4 selected circulating heterogeneous A/H1N1 influenza strains 3 weeks after influenza vaccination versus baseline.

Conditions

Interventions

BIOLOGICAL

Inflexal V

Inflexal V influenza vaccine, formulated for the WHO requirements ofr the 2011-2012 season, containing per 0.5 mL dose: * 15 µg hemagglutinin (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 Dose: intramuscular administration (M. deltoideus) of a single dose of 0.5 mL on Day 1

Sponsors & Collaborators

  • Crucell Holland BV

    lead INDUSTRY

Principal Investigators

  • Giancarlo Icardi, MD · San Martino University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • Italy

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 NCT01457027 on ClinicalTrials.gov