A Study for Evaluation of Immunogenicity and Reactogenicity of FluarixTM / Influsplit SSW® 2009/2010 in Adults

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00920374
• Date of registration: 12/06/2009
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: A Study for Evaluation of Immunogenicity and Reactogenicity of FluarixTM / Influsplit SSW® 2009/2010 in Adults
• Scientific title: A Phase III Study for Evaluation of Immunogenicity and Reactogenicity of FluarixTM / Influsplit SSW® 2009/2010 in People Aged 18 Years or Above
• Date of first enrolment: June 16, 2009
• Target sample size: 118
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00920374
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Germany

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects who the investigator believes that they can and will comply with the
requirements of the protocol should be enrolled in the study.

- A male or female aged 18 years or above at the time of the vaccination.

- Written informed consent obtained from the subject.

- Healthy subjects or with well-controlled chronic diseases as established by medical
history and clinical examination before entering into the study.

- If the subject is female, she must be of non-childbearing potential or if she is of
childbearing potential, she must practice adequate contraception for 30 days prior to
vaccination, have a negative pregnancy test and continue such precautions for 2 months
after completion of the vaccination series.

Exclusion Criteria:

- Use of any investigational or non-registered product other than the study vaccine(s)
within 30 days preceding the vaccination or planned use during the study period.

- Chronic administration of immunosuppressants or other immune-modifying drugs within
six months prior to the vaccine dose.

- Administration of immunoglobulins and/or any blood products within the three months
preceding the administration of the study vaccine or planned during the study.

- Administration of an influenza vaccine within 6 months preceding the study start.

- Administration of an influenza vaccine other than the study vaccine during the entire
study

- Clinically or virologically confirmed influenza infection within 6 months preceding
the study start

- History of allergic disease or reactions likely to be exacerbated by any component of
the vaccine.

- Acute disease at the time of enrolment.

- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional
abnormality, as determined by physical examination or laboratory screening tests.

- Not stabilized or clinically serious chronic underlying disease.

- Lactating female.

- History of chronic alcohol consumption and/or drug abuse.

- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
medical history and physical examination.

- Any condition which, in the opinion of the investigator, prevents the subject from
participation in the study.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Influenza

Intervention(s)

Biological: Fluarix™/Influsplit SSW®

Primary Outcome(s)

Number of Seroconverted Subjects [Time Frame: Day 21]

Seroconversion Factor [Time Frame: Day 21]

Hemagglutination Inhibition (HI) Antibody Titer [Time Frame: Day 0 and Day 21]

Number of Subjects With HI Antibody Titer Above the Cut-off Value [Time Frame: Day 0 and Day 21]

Number of Seroprotected Subjects [Time Frame: Day 0 and Day 21]

Seroprotection Power [Time Frame: Day 21]

Secondary Outcome(s)

Number of Subjects Reporting Unsolicited Adverse Events (AE) [Time Frame: During the 21-day (Day 0-20) post-vaccination period]

Number of Subjects Reporting Serious Adverse Events (SAE) [Time Frame: During the entire study period]

Number of Subjects Reporting Solicited General Symptoms [Time Frame: During the 4-day (Day 0-3) post-vaccination period]

Number of Subjects Reporting Solicited Local Symptoms [Time Frame: During the 4-day (Day 0-3) post-vaccination period]

Secondary ID(s)

113018

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 27/07/2010
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00920374