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

September 14, 2016 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

157

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

  • Germany
      • Berlin, Germany, 10315
        • GSK Investigational Site
      • Berlin, Germany, 12627
        • GSK Investigational Site
      • Berlin, Germany, 13355
        • GSK Investigational Site
    • Mecklenburg-Vorpommern
      • Buetzow, Mecklenburg-Vorpommern, Germany, 18246
        • GSK Investigational Site
      • Rostock, Mecklenburg-Vorpommern, Germany, 18106
        • GSK Investigational Site
    • Sachsen
      • Bischofswerda, Sachsen, Germany, 01877
        • GSK Investigational Site
      • Coswig, Sachsen, Germany, 01640
        • GSK Investigational Site
      • Dresden, Sachsen, Germany, 01307
        • GSK Investigational Site
      • Dresden, Sachsen, Germany, 01169
        • GSK Investigational Site
      • Leipzig, Sachsen, Germany, 04209
        • GSK Investigational Site
    • Schleswig-Holstein
      • Bad Segeberg, Schleswig-Holstein, Germany, 23795
        • GSK Investigational Site
      • Flensburg, Schleswig-Holstein, Germany, 24937
        • GSK Investigational Site
      • Husum, Schleswig-Holstein, Germany, 25813
        • GSK Investigational Site

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

6 months to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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
Subjects aged between 6 months and 3 years.
Biological: Thiomersal free trivalent influenza split vaccine 2003/2004
2 doses, intramuscular injection
Experimental: Group B
Subjects aged 3 to 6 years.
Biological: Thiomersal free trivalent influenza split vaccine 2003/2004
2 doses, intramuscular injection
Active Comparator: Group C
Subjects aged between 6 months and 3 years.
Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004
2 doses, intramuscular injection
Other Names:
  • Thiomersal free trivalent influenza split vaccine 2003/2004
Active Comparator: Group D
Subjects aged 3 to 6 years.
Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004
2 doses, intramuscular injection
Other Names:
  • Thiomersal free trivalent influenza split vaccine 2003/2004

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
On Day 21 (+- 2) after the second vaccination

Secondary Outcome Measures

Outcome Measure
Time Frame
Descriptive comparison of the occurrence and severity of solicited local and general symptoms
Time Frame: Within 4 days after each vaccination
Within 4 days after each vaccination
Descriptive comparison of the occurrence, severity and relationship to vaccination of unsolicited signs and symptoms
Time Frame: Within 30 days after each vaccination
Within 30 days after each vaccination
Descriptive comparison of the occurrence, severity and relationship to vaccination of serious adverse events (SAEs).
Time Frame: Throughout the study
Throughout the study
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
On Day 21 (+- 2), Month 3 and Month 6 after the second vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

October 1, 2003

Primary Completion (Actual)

August 1, 2004

Study Completion (Actual)

August 1, 2004

Study Registration Dates

First Submitted

August 7, 2008

First Submitted That Met QC Criteria

August 7, 2008

First Posted (Estimate)

August 11, 2008

Study Record Updates

Last Update Posted (Estimate)

September 15, 2016

Last Update Submitted That Met QC Criteria

September 14, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100351

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

Study Data/Documents

  1. Study Protocol
    Information identifier: 100351
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Clinical Study Report
    Information identifier: 100351
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Individual Participant Data Set
    Information identifier: 100351
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Statistical Analysis Plan
    Information identifier: 100351
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Annotated Case Report Form
    Information identifier: 100351
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Dataset Specification
    Information identifier: 100351
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Informed Consent Form
    Information identifier: 100351
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

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.

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