---
title: Reacto & Immunogenicity of TF Formulation of Influsplit SSW® 2002/03 v/s Std Formulation of Influsplit SSW® 2002/03
nct_id: NCT00731029
overall_status: COMPLETED
phase: PHASE3
sponsor: GlaxoSmithKline
study_type: INTERVENTIONAL
primary_condition: Influenza
countries: Germany
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00731029.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00731029"
ct_last_update_post_date: 2008-08-08
last_seen_at: "2026-05-12T06:24:22.113Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Reacto & Immunogenicity of TF Formulation of Influsplit SSW® 2002/03 v/s Std Formulation of Influsplit SSW® 2002/03

**Official Title:** 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

**NCT ID:** [NCT00731029](https://clinicaltrials.gov/study/NCT00731029)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 239
- **Lead Sponsor:** GlaxoSmithKline
- **Conditions:** Influenza
- **Start Date:** 2002-09
- **CT.gov Last Update:** 2008-08-08

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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
```

## Arms

- **Group A** (EXPERIMENTAL) — The subjects in this group will be 18-60 years.
- **Group B** (EXPERIMENTAL) — The subjects in this group will be \> 60 years.
- **Group C** (ACTIVE_COMPARATOR) — The subjects in this group will be 18-60 years.
- **Group D** (ACTIVE_COMPARATOR) — The subjects in this group will be \> 60 years.

## Interventions

- **Thiomersal free trivalent influenza split vaccine 2002/2003** (BIOLOGICAL) — Single dose, intramuscular injection
- **GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2002/2003** (BIOLOGICAL) — Single dose, intramuscular injection

## Primary Outcomes

- **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)_
- **Descriptive comparison of the occurrence, severity and causal relationship to vaccination of solicited local and general symptoms** _(time frame: Within 4 days after vaccination)_

## Secondary Outcomes

- **Descriptive comparison of the occurrence and causal relationship to vaccination of unsolicited signs and symptoms** _(time frame: 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.)_
- **Investigation of antibody persistence assessed by the criteria of the CHMP.** _(time frame: 11, 19, 27 weeks after vaccination)_

## Locations (1)

- GSK Clinical Trials Call Center, Dresden, Germany

## Recent Field Changes (last 30 days)

- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `locations.gsk clinical trials call center|dresden||germany` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00731029.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00731029*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*