Trial record 6 of 35 for:    Thimerosal

Reacto & Immunogenicity of TF Formulation of Influsplit SSW® 2002/03 v/s Std Formulation of Influsplit SSW® 2002/03

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00731029
First received: August 7, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  Purpose

This is a comparative vaccination study of the reactogenicity and immunogenicity of a thiomersal-free formulation of Influsplit SSW® 2002/2003 versus the standard formulation of Influsplit SSW® 2002/2003 in individuals over 18 years.


Condition Intervention Phase
Influenza
Biological: Thiomersal free trivalent influenza split vaccine 2002/2003
Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2002/2003
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Comparative Vaccination Study of the Reactogenicity and Immunogenicity of a Thiomersal-Free Formulation of Influsplit SSW® 2002/2003 Versus the Standard Formulation of Influsplit SSW® 2002/2003 in Individuals Over 18 Years

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • GMT of the haemagglutination-inhibiting antibodies (HIA) and calculation of seroconversion factor, seroconversion rate and seroprotection rate checked against the CHMP criteria. The seroprotection power will be calculated as well. [ Time Frame: On Day 21 (± 2) after vaccination ]
  • Descriptive comparison of the occurrence, severity and causal relationship to vaccination of solicited local and general symptoms [ Time Frame: Within 4 days after vaccination ]

Secondary Outcome Measures:
  • Descriptive comparison of the occurrence and causal relationship to vaccination of unsolicited signs and symptoms [ Time Frame: Within 30 days after vaccination ]
  • Descriptive comparison of the occurrence, severity and causal relationship to vaccination of any serious adverse events (SAEs) [ Time Frame: During the entire study period. ]
  • Investigation of antibody persistence assessed by the criteria of the CHMP. [ Time Frame: 11, 19, 27 weeks after vaccination ]

Enrollment: 239
Study Start Date: September 2002
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
The subjects in this group will be 18-60 years.
Biological: Thiomersal free trivalent influenza split vaccine 2002/2003
Single dose, intramuscular injection
Experimental: Group B
The subjects in this group will be > 60 years.
Biological: Thiomersal free trivalent influenza split vaccine 2002/2003
Single dose, intramuscular injection
Active Comparator: Group C
The subjects in this group will be 18-60 years.
Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2002/2003
Single dose, intramuscular injection
Active Comparator: Group D
The subjects in this group will be > 60 years.
Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2002/2003
Single dose, intramuscular injection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects who are capable of being vaccinated and subjects with primary diseases (cardiovascular conditions, metabolic conditions such as diabetes mellitus, respiratory diseases) who are capable of being vaccinated and aged over 18 years who want to be vaccinated against influenza or for whom the doctor considers prophylactic influenza immunisation to be indicated.
  • The inclusion of individuals who had not been immunised in the 2001/2002 season is preferred.
  • Written consent to vaccination must be available after the subjects have been briefed on the study in understandable language.

Exclusion Criteria:

  • Use of study or unlicensed medication or administration of a vaccine other than the study vaccine within 30 days preceding vaccination and/or during the study period
  • Acute disease at the beginning of the study
  • Acute clinically significant changes in the lungs, cardiovascular system, liver or kidney function, identified by physical examination or laboratory tests
  • Pregnancy
  • Women who would like to fall pregnant during the period from the day of vaccination to 1 month thereafter
  • Known allergic reactions that might have been caused by one or more ingredients of the vaccine
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00731029

Locations
Germany
GSK Clinical Trials Call Center
Dresden, Germany
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Isabelle Harpigny, GSK Biologicals
ClinicalTrials.gov Identifier: NCT00731029     History of Changes
Other Study ID Numbers: 218352/053
Study First Received: August 7, 2008
Last Updated: August 7, 2008
Health Authority: Germany: Paul-Ehrlich Institute

Keywords provided by GlaxoSmithKline:
Influenza
Thiomersal-free influenza split vaccine 2002/2003
Influsplit SSW®/Fluarix™ 2002/2003

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014