Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate in Adults.

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00714285
• Date of registration: 11/07/2008
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate in Adults.
• Scientific title: Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate GSK 2115160A in Adults.
• Date of first enrolment: July 14, 2008
• Target sample size: 420
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00714285
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Participant).
• Phase: Phase 1

Countries of recruitment

Czech Republic, Czechia

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy subjects as established by medical history and clinical examination before
entering into the study.

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

- A male or female between, and including, 18 and 60 years of age at the time of the
vaccination.

- Written informed consent obtained from the subject.

- If the subject is female, she must be of non-childbearing potential, 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 vaccine(s) within 30 days preceding the administration of study vaccine, or
planned use during the study period.

- Chronic administration (defined as more than 14 days) of immunosuppressants or other
immune-modifying drugs within 3 months prior to administration of the vaccine.

- Administration of a vaccine not foreseen in the study protocol from 30 days before
vaccination up to 21 days post vaccination.

- Confirmed influenza infection within a year preceding the study start.

- Administration of an influenza vaccine during Northern Hemisphere season 2007-2008.

- Concurrently participating in another clinical study, at any time during the study
period, in which the subject has been or will be exposed to an investigational or a
non-investigational product (pharmaceutical product or device).

- History of hypersensitivity to a previous dose of influenza vaccine

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

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

- Acute disease at the time of enrolment.

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

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

- Pregnant or lactating female.

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

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

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

- History of administration of experimental/licensed vaccine.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Influenza

Intervention(s)

Biological: GSK Biologicals' quadrivalent influenza vaccine

Biological: GSK Biologicals' trivalent influenza vaccine

Primary Outcome(s)

Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. [Time Frame: At Day 0 and Day 21]

Secondary Outcome(s)

Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains. [Time Frame: At Day 21]

Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading. [Time Frame: During a 7-day follow-up period (Days 0-6) after vaccination]

Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. [Time Frame: During a 7-day follow-up period (Days 0-6) after vaccination]

HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains [Time Frame: Day 21]

Number of Subjects Reporting Any Medically Significant Conditions (MSCs) and Auto-immune Diseases (AIDs). [Time Frame: During the entire study period (Days 0-180)]

Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AE(s). [Time Frame: During a 21 day (Days 0-20) follow-up period after vaccination-]

Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. [Time Frame: During a 7 day (Days 0-6) follow-up period after vaccination]

Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains. [Time Frame: At Days 0 and 21]

Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) [Time Frame: During the entire study period (Days 0-180)]

Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading. [Time Frame: During a 7-day follow-up period (Days 0-6) after vaccination]

Secondary ID(s)

111295

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 16/09/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00714285