search
Back to results

Immuno & Reacto of TF Trivalent Influenza Split Vaccine 2003/04 or of Std Formulation Influsplit SSW®/Fluarix™ 2003/04

Primary Purpose

Influenza

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Thiomersal free trivalent influenza split vaccine 2003/2004
GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Thiomersal-free influenza split vaccine 2003/2004, Influsplit SSW®/Fluarix™ 2003/2004, Influenza

Eligibility Criteria

6 Months - 6 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subjects whose parents/guardians the investigator believes can and will comply with the requirements of the protocol
  • Male or female children over 6 months of age at the time of vaccination, but who are not yet 6 years old.
  • All children included in the study must never have been given a prophylactic influenza inoculation.
  • Written consent to vaccination must be available from both parents or only the single parent after the parents/guardians have been briefed on the study in an 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 until 30 days after administration of the second vaccine dose.
  • 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.
  • Known allergic reactions that might have been caused by one or more components of the vaccine.
  • Administration of immunoglobulins and/or other blood products within 3 months before the beginning of the study or planned administration during the study period.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

Group A

Group B

Group C

Group D

Arm Description

Subjects aged between 6 months and 3 years.

Subjects aged 3 to 6 years.

Subjects aged between 6 months and 3 years.

Subjects aged 3 to 6 years.

Outcomes

Primary Outcome Measures

GMT of the haemagglutination-inhibiting (HI) antibodies and calculation of seroconversion factor, seroconversion rate & seroprotection rate, checked against CHMP criteria (for 18 - 60 years old); seroprotection power is also calculated.

Secondary Outcome Measures

Descriptive comparison of the occurrence and severity of solicited local and general symptoms
Descriptive comparison of the occurrence, severity and relationship to vaccination of unsolicited signs and symptoms
Descriptive comparison of the occurrence, severity and relationship to vaccination of serious adverse events (SAEs).
GMT of the HI antibodies in each case against the 3 influenza virus strains of the vaccine separately for both age groups.

Full Information

First Posted
August 7, 2008
Last Updated
September 14, 2016
Sponsor
GlaxoSmithKline
search

1. Study Identification

Unique Protocol Identification Number
NCT00731393
Brief Title
Immuno & Reacto of TF Trivalent Influenza Split Vaccine 2003/04 or of Std Formulation Influsplit SSW®/Fluarix™ 2003/04
Official Title
To Determine the Immunogenicity and Reactogenicity of a Thiomersal Free Trivalent Influenza Split Vaccine 2003/2004 or of GSK Biologicals' Standard Formulation Influsplit SSW®/Fluarix™ 2003/2004 in Children Aged From 6 Months Until 6 Years
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
August 2004 (Actual)
Study Completion Date
August 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the present study is to assess the reactogenicity and immunogenicity of a thiomersal-free influenza vaccine. For comparison, a group of subjects is administered the standard formulation of Influsplit SSW® 2003/2004.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Thiomersal-free influenza split vaccine 2003/2004, Influsplit SSW®/Fluarix™ 2003/2004, Influenza

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
157 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Subjects aged between 6 months and 3 years.
Arm Title
Group B
Arm Type
Experimental
Arm Description
Subjects aged 3 to 6 years.
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
Subjects aged between 6 months and 3 years.
Arm Title
Group D
Arm Type
Active Comparator
Arm Description
Subjects aged 3 to 6 years.
Intervention Type
Biological
Intervention Name(s)
Thiomersal free trivalent influenza split vaccine 2003/2004
Intervention Description
2 doses, intramuscular injection
Intervention Type
Biological
Intervention Name(s)
GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004
Other Intervention Name(s)
Thiomersal free trivalent influenza split vaccine 2003/2004
Intervention Description
2 doses, intramuscular injection
Primary Outcome Measure Information:
Title
GMT of the haemagglutination-inhibiting (HI) antibodies and calculation of seroconversion factor, seroconversion rate & seroprotection rate, checked against CHMP criteria (for 18 - 60 years old); seroprotection power is also calculated.
Time Frame
On Day 21 (+- 2) after the second vaccination
Secondary Outcome Measure Information:
Title
Descriptive comparison of the occurrence and severity of solicited local and general symptoms
Time Frame
Within 4 days after each vaccination
Title
Descriptive comparison of the occurrence, severity and relationship to vaccination of unsolicited signs and symptoms
Time Frame
Within 30 days after each vaccination
Title
Descriptive comparison of the occurrence, severity and relationship to vaccination of serious adverse events (SAEs).
Time Frame
Throughout the study
Title
GMT of the HI antibodies in each case against the 3 influenza virus strains of the vaccine separately for both age groups.
Time Frame
On Day 21 (+- 2), Month 3 and Month 6 after the second vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects whose parents/guardians the investigator believes can and will comply with the requirements of the protocol Male or female children over 6 months of age at the time of vaccination, but who are not yet 6 years old. All children included in the study must never have been given a prophylactic influenza inoculation. Written consent to vaccination must be available from both parents or only the single parent after the parents/guardians have been briefed on the study in an 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 until 30 days after administration of the second vaccine dose. 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. Known allergic reactions that might have been caused by one or more components of the vaccine. Administration of immunoglobulins and/or other blood products within 3 months before the beginning of the study or planned administration during the study period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Buetzow
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
18246
Country
Germany
Facility Name
GSK Investigational Site
City
Rostock
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
18106
Country
Germany
Facility Name
GSK Investigational Site
City
Bischofswerda
State/Province
Sachsen
ZIP/Postal Code
01877
Country
Germany
Facility Name
GSK Investigational Site
City
Coswig
State/Province
Sachsen
ZIP/Postal Code
01640
Country
Germany
Facility Name
GSK Investigational Site
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01169
Country
Germany
Facility Name
GSK Investigational Site
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
GSK Investigational Site
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04209
Country
Germany
Facility Name
GSK Investigational Site
City
Bad Segeberg
State/Province
Schleswig-Holstein
ZIP/Postal Code
23795
Country
Germany
Facility Name
GSK Investigational Site
City
Flensburg
State/Province
Schleswig-Holstein
ZIP/Postal Code
24937
Country
Germany
Facility Name
GSK Investigational Site
City
Husum
State/Province
Schleswig-Holstein
ZIP/Postal Code
25813
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10315
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
12627
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13355
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
100351
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
100351
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
100351
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
100351
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
100351
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
100351
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
100351
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

Immuno & Reacto of TF Trivalent Influenza Split Vaccine 2003/04 or of Std Formulation Influsplit SSW®/Fluarix™ 2003/04

We'll reach out to this number within 24 hrs