Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 2010/2011 Season

NCT01146015 | Completed Phase 3

• 2 other identifiers: S201.3.1302010-018350-13
• Study Type: interventional
• Target: 121
• Locations: 2 countries
• Sites: 2

Brief Summary

Influenza (flu) viruses change continuously, therefore also the parts of viruses used in influenza vaccines can vary from year to year. In Europe, manufacturers/marketing holders of these vaccines are required to be involved in ongoing clinical trials and to present the results to the competent authorities each year. The current study is a phase IIIa clinical trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. It is part of the ongoing clinical trial program for Influvac® and will be done to assess the immunogenicity and safety and tolerability of next season's trivalent influenza subunit vaccine in two groups of subjects in good health: subjects aged \>= 18 and \<= 60 years and subjects \>= 61 years of age (elderly)

Conditions

Influenza

Keywords

Influenza; Vaccine; CHMP criteria

Outcome Measures

Primary Outcomes (2)

• HI titers and its derived parameters after 2 weeks (seroprotection, seroconversion and mean fold increase), reactogenicity and inconvenience of Influvac® 2010/2011 as defined by the CHMP guideline for influenza vaccines

  2 weeks

• HI titers and its derived parameters after 3 weeks (seroprotection, seroconversion and mean fold increase), reactogenicity and inconvenience of Influvac® 2010/2011 as defined by the CHMP guideline for influenza vaccines

  3 weeks

Study Arms (1)

1

EXPERIMENTAL

Biological: Trivalent influenza subunit vaccine Influvac

Interventions

Trivalent influenza subunit vaccine Influvac BIOLOGICAL

3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to give informed consent and able to adhere to all protocol required study procedures.
• Men and women aged \>= 18 and \<= 60 years or \>= 61 years of age at the day of study vaccination.
• Being in good health as judged by medical history, physical examination and clinical judgment of the investigator

You may not qualify if:

• Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine.
• A serious adverse reaction after a previous (influenza) vaccination.
• Seasonal or pandemic influenza vaccination or laboratory confirmed seasonal or pandemic influenza infection within the previous six months before study vaccination or planned vaccination during the study period.
• A history of Guillain-Barré syndrome or active neurological disease

Sponsors & Collaborators

• Abbott Biologicals: lead
• Quintiles, Inc.: collaborator

Study Sites (2)

Site Reference ID/Investigator# 44974

Tessenderlo, 3890, Belgium

Location

Site Reference ID/Investigator# 44975

Hamburg, 22769, Germany

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Hanka de Voogd, MD

  Abbott Healthcare Products B.V.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2010
• First Posted: June 17, 2010
• Study Start: June 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: August 26, 2011

Record last verified: 2011-08

Locations

BE (1); DE (1)