Reacto & Immunogenicity of TF Formulation of Influsplit SSW® 2002/03 v/s Std Formulation of Influsplit SSW® 2002/03
August 7, 2008 updated by: GlaxoSmithKline
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
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
239
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Dresden, Germany
- GSK Clinical Trials Call Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A
The subjects in this group will be 18-60 years.
|
Single dose, intramuscular injection
|
|
Experimental: Group B
The subjects in this group will be > 60 years.
|
Single dose, intramuscular injection
|
|
Active Comparator: Group C
The subjects in this group will be 18-60 years.
|
Single dose, intramuscular injection
|
|
Active Comparator: Group D
The subjects in this group will be > 60 years.
|
Single dose, intramuscular injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
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
|
Within 4 days after vaccination
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Descriptive comparison of the occurrence and causal relationship to vaccination of unsolicited signs and symptoms
Time Frame: Within 30 days after vaccination
|
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.
|
During the entire study period.
|
|
Investigation of antibody persistence assessed by the criteria of the CHMP.
Time Frame: 11, 19, 27 weeks after vaccination
|
11, 19, 27 weeks after vaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2002
Primary Completion (Actual)
April 1, 2003
Study Registration Dates
First Submitted
August 7, 2008
First Submitted That Met QC Criteria
August 7, 2008
First Posted (Estimate)
August 8, 2008
Study Record Updates
Last Update Posted (Estimate)
August 8, 2008
Last Update Submitted That Met QC Criteria
August 7, 2008
Last Verified
August 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 218352/053
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.