Evaluation of Safety and Immunogenicity of GSK Bio's Influenza Vaccine GSK576389A After Repeated Vaccination in Elderly Adults

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00538213
• Date of registration: 01/10/2007
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: Evaluation of Safety and Immunogenicity of GSK Bio's Influenza Vaccine GSK576389A After Repeated Vaccination in Elderly Adults
• Scientific title: Reactogenicity and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK576389A in Elderly Adults (=66 Years) Previously Vaccinated With the Same Candidate Vaccine. Fluarix™ Will be Used as Reference
• Date of first enrolment: October 15, 2007
• Target sample size: 133
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00538213
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Belgium

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects who were previously vaccinated with GlaxoSmithKline Biologicals Fluarix™ or
GSK576389A investigational vaccines in the 104887 study (NCT00386698).

- 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 between 19 and 42 years or 66 years and older at the time of the
vaccination.

- Written informed consent obtained from the subject.

- Free of an acute aggravation of the health status as established by clinical
evaluation 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 (drug or vaccine) other than the
study vaccines within 30 days prior to vaccination, or planned use during the study
period.

- Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or
4 weeks (for live vaccines) prior to enrolment in this study. Planned administration
of a vaccine not foreseen by the study protocol up to 21 days after vaccination.

- Planned administration of an influenza vaccine other than the study vaccines during
the entire study period.

- Vaccination against influenza since January 2007 with the Northern Hemisphere
2007/2008 influenza vaccine or 2006/2007 influenza vaccine.

- History of confirmed influenza infection since the date of previous vaccination.

- Chronic administration (defined as more than 14 days) of immunosuppressants or other
immune-modifying drugs within six months prior to the administration of the study
vaccine. (For corticosteroids, this will mean prednisone, or equivalent, =0.5
mg/kg/day. Inhaled and topical steroids are allowed.)

- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
medical history and physical examination (no laboratory testing required).

- 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(s)

- Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal
functional abnormality, as determined by clinical evaluation (medical history and
medical history directed physical examination) or pre-existing laboratory screening
tests.

- Acute disease at the time of enrolment. (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. Axillary temperature <37.5°C / Oral
temperature of <37.5°C).

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

- Any medical conditions in which intramuscular injections are contraindicated.

- Pregnant or lactating female.

- Female planning to become pregnant or planning to discontinue contraceptive
precautions.



Age minimum: 19 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Influenza

Intervention(s)

Biological: Fluarix™

Biological: GSK Bio's Influenza Vaccine GSK576389A

Primary Outcome(s)

Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs [Time Frame: Day 0-20]

Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) [Time Frame: Day 0-6]

Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs [Time Frame: Day 0-6]

Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) [Time Frame: Day 0-20]

Duration of Solicited Local AEs [Time Frame: Day 0-6]

Number of Subjects Reporting at Least One, Grade 3 and Related Medically Significant Conditions (MSCs) [Time Frame: Day 0-20]

Duration of Solicited General AEs [Time Frame: Day 0-6]

Secondary Outcome(s)

The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker [Time Frame: At Days 0 and 21]

HI Antibody Seroconversion Factors (SCF) [Time Frame: At Day 21]

The Number of Subjects Seroconverted to HI Antibodies [Time Frame: At Day 21]

Haemagglutination Inhibition (HI) Antibody Titers [Time Frame: At Days 0 and 21]

The Number of Subjects Seropositive to HI Antibodies [Time Frame: At Days 0 and 21]

The Number of Subjects Seroprotected to HI Antibodies [Time Frame: At Days 0 and 21]

The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker [Time Frame: At Days 0 and 21]

Secondary ID(s)

110263

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 05/09/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00538213