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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00731393
• Other study ID #: 100351
• Status: Completed
• Phase: Phase 3
• First received: August 7, 2008
• Last updated: September 14, 2016
• Start date: October 2003
• Est. completion date: August 2004

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Pau-Ehrlich Institute
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: August 2004
• Est. primary completion date: August 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 6 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Thiomersal free trivalent influenza split vaccine 2003/2004
2 doses, intramuscular injection
• GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004
2 doses, intramuscular injection

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Bad Segeberg	Schleswig-Holstein
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Bischofswerda	Sachsen
Germany	GSK Investigational Site	Buetzow	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Coswig	Sachsen
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Flensburg	Schleswig-Holstein
Germany	GSK Investigational Site	Husum	Schleswig-Holstein
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Rostock	Mecklenburg-Vorpommern

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		On Day 21 (+- 2) after the second vaccination
Secondary	Descriptive comparison of the occurrence and severity of solicited local and general symptoms		Within 4 days after each vaccination
Secondary	Descriptive comparison of the occurrence, severity and relationship to vaccination of unsolicited signs and symptoms		Within 30 days after each vaccination
Secondary	Descriptive comparison of the occurrence, severity and relationship to vaccination of serious adverse events (SAEs).		Throughout the study
Secondary	GMT of the HI antibodies in each case against the 3 influenza virus strains of the vaccine separately for both age groups.		On Day 21 (+- 2), Month 3 and Month 6 after the second vaccination

External Links

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