Safety & Immunogenicity of an Alternative Immunization Schedule of GSK Bio's Pandemic Influenza Vaccine (GSK1119711A)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00430521
• Date of registration: 01/02/2007
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: Safety & Immunogenicity of an Alternative Immunization Schedule of GSK Bio's Pandemic Influenza Vaccine (GSK1119711A)
• Scientific title: Reactogenicity and Immunogenicity Study of GlaxoSmithKline Biologicals' Pandemic Influenza Vaccine (GSK1119711A) Administered According to Different Vaccination Schedules
• Date of first enrolment: February 5, 2007
• Target sample size: 512
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00430521
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 2

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 between, and including, 18 and 60 years of age at the time of the
first vaccination.

- Written informed consent obtained from the subject.

- Healthy subjects 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 of
childbearing potential, she must be abstinent or have used adequate contraceptive
precautions for 30 days prior to first vaccination, have a negative pregnancy test and
must agree to continue such precautions for two months after completion of the
vaccination series.

Exclusion Criteria:

- Administration of licensed vaccines within 2 weeks (for inactivated vaccines) or 4
weeks (for live vaccines) prior to enrolment in this study.

- History of vaccination with investigational influenza pandemic vaccine.

- History of administration of an experimental/licensed vaccine

- Planned administration of a vaccine not foreseen by the study protocol during the
following periods: from Day 0 up to Day 51; from 2 weeks (for inactivated vaccines) or
4 weeks (for live vaccines) prior to Month 6 and Month 12; from Month 6 up to Month 6
+ 30 days; from Month 12 up to Month 12 + 30 days.

- Chronic administration (defined as more than 14 days) of immunosuppressants or other
immune-modifying drugs within six months prior to the first administration of the
candidate vaccines

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

- History of hypersensitivity to vaccines.

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

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

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

- Serious chronic disease including any medically significant chronic pulmonary,
cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined
by medical history and physical examination.

- Acute disease at the time of enrolment.

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

- Lactating women.

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

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



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

Health Condition(s) or Problem(s) studied

Influenza

Influenza Vaccines

Intervention(s)

Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 1

Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 2

Primary Outcome(s)

Booster Factor of H5N1 HI Antibodies Against 2 Strains of Influenza Disease [Time Frame: At Month 6 + 7 Days]

Booster Factor of H5N1 HI Antibodies Against 2 Strains of Influenza Disease [Time Frame: At Month 6 + 21 Days]

Geometric Mean Titers (GMTs) of H5N1 HI Antibodies [Time Frame: At Month 6 + 21 Days]

Number of Seroprotected Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease [Time Frame: At Month 6]

Geometric Mean Titers (GMTs) of H5N1 HI Antibodies [Time Frame: At Month 6 + 7 Days]

Number of Seroprotected Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease [Time Frame: At Month 6 + 7 Days]

Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [Time Frame: During the 30-day (Days 0-29) post-booster vaccination period (Month 12 + 30 days)]

Number of Subjects With Serious Adverse Events (SAEs) [Time Frame: During the entire study period (Day 0 to Month 18)]

Geometric Mean Titers (GMTs) of H5N1 HI Antibodies [Time Frame: At Day 0]

Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [Time Frame: During the 30-day (Days 0-29) post-primary vaccination period (Month 6 + 30 days)]

Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease [Time Frame: At Month 6 + 21 days]

Number of Subjects With H5N1 Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value [Time Frame: At Month 6 + 21 Days]

Number of Subjects With H5N1 Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value [Time Frame: At Month 6]

Seroconversion Factor for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease [Time Frame: At Month 6 + 7 Days]

Number of Subjects With Any and Grade 3 Solicited Local Symptoms [Time Frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses, up to 6/12 months + 7 days]

Number of Subjects With H5N1 Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value [Time Frame: At Day 0]

Seroconversion Factor for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease [Time Frame: At Month 6]

Number of Seroconverted Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease [Time Frame: At Month 6]

Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [Time Frame: During the entire study period (Day 0 to Month 18)]

Number of Subjects With H5N1 Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value [Time Frame: At Month 6 + 7 Days]

Seroconversion Factor for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease [Time Frame: At Month 6 + 21 Days]

Geometric Mean Titers (GMTs) of H5N1 HI Antibodies [Time Frame: At Month 6]

Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease [Time Frame: At Month 6 + 7 Days]

Number of Seroconverted Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease [Time Frame: At Month 6 + 21 Days]

Number of Seroconverted Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease [Time Frame: At Month 6 + 7 Days]

Number of Seroprotected Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease [Time Frame: At Day 0]

Number of Seroprotected Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease [Time Frame: At Month 6 + 21 Days]

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [Time Frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses, up to 12 months + 7 days]

Secondary Outcome(s)

Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12 [Time Frame: At Month 12 + 7 Days and Month 12 + 21 Days]

GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12 [Time Frame: At Day 0, Day 21, Day 42, Month 6, Month 12, Month 12 + 7 Days, Month 12 + 21 Days and Month 18]

Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6 [Time Frame: At Month 6 + 7 Days, Month 6 + 21 Days, Month 12 and Month 18]

Number of Seroconverted Subjects for H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6 [Time Frame: At Day 21, Day 42, Month 6, Month 6 + 7 Days, Month 6 + 21 Days and Month 12]

GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Adults Who Received Booster Dose at Month 6 [Time Frame: At Day 0, Day 21, Day 42, Month 6, Month 6 + 7 Days, Month 6 + 21 Days and Month 12]

Booster Factor of H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12 [Time Frame: At Month 12 + 7 Days, Month 12 + 21 Days and at Month 18]

Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12 [Time Frame: At Month 12 + 7 Days, Month 12 + 21 Days and Month 18]

GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Adults Who Received Booster Dose at Month 12 [Time Frame: At Day 0, Day 21, Day 42, Month 6, Month 12, Month 12 + 7 Days and Month 12 + 21 Days]

Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12 [Time Frame: At Day 21, Day 42, Month 6, Month 12, Month 12 + 7 Days, Month 12 + 21 Days]

Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12 [Time Frame: At Month 12 + 7 Days, Month 12 + 21 Days and Month 18]

Number of Seroprotected Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6 [Time Frame: At Day 0, Day 21, Day 42, Month 6, Month 6+ 7 Days, Month 6+ 21 Days, Month 12 and Month 18]

Number of Seroconverted Subjects for H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12 [Time Frame: At Day 21, Day 42, Month 6, Month 12, Month 12 + 7 Days and Month 12 + 21 Days]

Number of Seroprotected Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 12 [Time Frame: At Day 0, Day 21, Day 42, Month 6, Month 12, Month 12 + 7 Days, Month 12 + 21 Days]

GMTs of H5N1 HI Antibodies Against 2 Strains of Influenza Disease for Groups Who Received Booster Dose at Month 12 [Time Frame: At Day 0, Day 21, Day 42, Month 6, Month 12, Month 12 + 7 Days, Month 12 + 21 Days and at Month 18]

Seroconversion Factor for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 12 [Time Frame: At Day 21, Day 42, Month 6, Month 12, Month 12 + 7 Days, Month 12 + 21 Days]

GMTs of H5N1 HI Antibody Titers, for Groups Who Received Booster Dose at Month 6 [Time Frame: At Day 0, Day 21, Day 42, Month 6, Month 6+ 7 Days, Month 6+ 21 Days, Month 12 and at Month 18]

Seroconversion Factor for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received the Booster Dose at Month 6 [Time Frame: At Day 21, Day 42, Month 6, Month 6 + 7 Days, Month 6 + 21 Days, Month 12 and Month 18]

Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 12 [Time Frame: At Day 0, Month 6, Month 12, Month 12 + 7 Days, Month 12 + 21 Days and Month 18]

Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease, A/Vietnam/1194/2004 and A/Indonesia/5/2005, for Groups Who Received Booster Dose at Month 12 [Time Frame: At Month 12 + 7 Days, Month 12 + 21 Days and Month 18]

Number of Seroconverted Subjects for H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6 [Time Frame: At Day 21, Day 42, Month 6, Month 6 + 7 Days, Month 6 + 21 Days, Month 12 and Month 18]

Booster Factor of H5N1 HI Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 12 [Time Frame: At Month 12 + 7 Days and at Month 12 + 21 Days]

Frequency of Influenza-specific CD4/CD8 T-cells (Per 10E6 T-cells) in Tests Identified as Producing at Least Two Out of Four Different Cytokines, for Groups Who Received Booster Dose at Month 6 [Time Frame: At Day 0, Month 6, Month 6 + 7 Days, Month 6 + 21 Days, Month 12 and Month 18]

GMTs of H5N1 Neutralizing Antibodies Against 2 Strains of Influenza Disease, for Groups Who Received Booster Dose at Month 6 [Time Frame: At Day 0, Day 21, Day 42, Month 6, Month 6 + 7 Days, Month 6 + 21 Days, Month 12 and Month 18]

Secondary ID(s)

2006-005477-22

107495

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 28/10/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00430521