NCT00731029

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
239

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2003

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 8, 2008

Completed
Last Updated

August 8, 2008

Status Verified

August 1, 2008

Enrollment Period

7 months

First QC Date

August 7, 2008

Last Update Submit

August 7, 2008

Conditions

Influenza

Keywords

InfluenzaThiomersal-free influenza split vaccine 2002/2003Influsplit SSW®/Fluarix™ 2002/2003

Outcome Measures

Primary Outcomes (2)

  • 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.

    On Day 21 (± 2) after vaccination

  • Descriptive comparison of the occurrence, severity and causal relationship to vaccination of solicited local and general symptoms

    Within 4 days after vaccination

Secondary Outcomes (3)

  • Descriptive comparison of the occurrence and causal relationship to vaccination of unsolicited signs and symptoms

    Within 30 days after vaccination

  • Descriptive comparison of the occurrence, severity and causal relationship to vaccination of any serious adverse events (SAEs)

    During the entire study period.

  • Investigation of antibody persistence assessed by the criteria of the CHMP.

    11, 19, 27 weeks after vaccination

Study Arms (4)

Group A

EXPERIMENTAL

The subjects in this group will be 18-60 years.

Biological: Thiomersal free trivalent influenza split vaccine 2002/2003

Group B

EXPERIMENTAL

The subjects in this group will be \> 60 years.

Biological: Thiomersal free trivalent influenza split vaccine 2002/2003

Group C

ACTIVE COMPARATOR

The subjects in this group will be 18-60 years.

Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2002/2003

Group D

ACTIVE COMPARATOR

The subjects in this group will be \> 60 years.

Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2002/2003

Interventions

Thiomersal free trivalent influenza split vaccine 2002/2003BIOLOGICAL

Single dose, intramuscular injection

Group AGroup B
GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2002/2003BIOLOGICAL

Single dose, intramuscular injection

Group CGroup D

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Written consent to vaccination must be available after the subjects have been briefed on the study in understandable language.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Clinical Trials Call Center

Dresden, Germany

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 7, 2008

First Posted

August 8, 2008

Study Start

September 1, 2002

Primary Completion

April 1, 2003

Last Updated

August 8, 2008

Record last verified: 2008-08

Locations

DE(1)