Post-marketing Study to Evaluate the Efficacy of Influenza Vaccine

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00197223
• Date of registration: 15/09/2005
• Prospective Registration: No
• Primary sponsor: GlaxoSmithKline
• Public title: Post-marketing Study to Evaluate the Efficacy of Influenza Vaccine
• Scientific title: A Randomized, Double-blind, Placebo-controlled, Post-marketing Phase III Study to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine (Fluarix™) Administered Intramuscularly in Adults.
• Date of first enrolment: September 2005
• Target sample size: 6213
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00197223
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Czech Republic

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion Criteria:

- A male or female age between, and including, 18 and 64 years of age at the time of the
vaccination.

- Written informed consent obtained from the subject.

- Availability to follow up by phone during the study period.

- Female subjects must be of non-childbearing potential, i.e. either surgically
sterilized or one year post-menopausal. If subject is of childbearing potential, she
must be abstinent or have used adequate contraceptive precautions for 30 days prior to
vaccination. She must also have a negative pregnancy test at study entry and must
agree to continue such precautions for two months after vaccination.

Exclusion Criteria:

- History of hypersensitivity to a previous dose of influenza vaccine.

- History of allergy or reactions likely to be exacerbated by any component of the
vaccine including egg, chicken protein, formaldehyde, thimerosal, gentamicin sulfate
or sodium deoxycholate.

- Acute disease at the time of enrollment. (Acute disease is defined as the presence of
a moderate or severe illness with or without fever). All vaccines can be administered
to persons with a minor illness such as diarrhea, mild upper respiratory infection
with or without low-grade febrile illness, i.e. Oral temperature < 37.5°C).

- Pregnancy

- Chronic disorders of the pulmonary or cardiovascular system, including asthma

- History of requiring regular medical follow-up or hospitalization during the preceding
year because of chronic metabolic diseases (including diabetes mellitus), renal
dysfunction, hemoglobinopathies, or immunosuppression (including immunosuppression
caused by medications or by human immunodeficiency virus.



Age minimum: 18 Years
Age maximum: 64 Years
Gender: All

Health Condition(s) or Problem(s) studied

Influenza

Intervention(s)

Biological: Influenza vaccine

Primary Outcome(s)

Incidence of culture confirmed influenza A and/or B during the surveillance period

Secondary Outcome(s)

Efficacy: Incidence of ILI, Number of days of fever, days of school/work absenteeism, hospitalization related to influenza illness, Incidence of pneumonia, Incidence of PCR confirmed influenza A and/or B

Secondary ID(s)

104438

Source(s) of Monetary Support

Please refer to primary and secondary sponsors