A Study for Evaluation of GSK Biologicals' Pandemic Influenza Vaccine

Influenza Clinical Trial

Official title:

Immunogenicity and Safety of GSK Biologicals' (Pre-) Pandemic Influenza Candidate Vaccine GSK 1562902A.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00866580
• Other study ID #: 112865
• Status: Withdrawn
• Phase: Phase 3
• First received: March 19, 2009
• Last updated: March 19, 2015
• Start date: May 2010
• Est. completion date: July 2011

Study information

• Verified date: March 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: ANVISA
• Study type: Interventional

Clinical Trial Summary

This observer-blind study is designed to evaluate the immune response and safety of pandemic influenza vaccine in the elderly population.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 61 Years and older

Eligibility

Inclusion Criteria:

• Male or female subjects aged 61 years or above at the time of the first study visit (Day -30).

• Female subjects of non-childbearing potential.

• Healthy subjects or subjects with well controlled chronic medical condition (at the discretion of the investigator).

• Written informed consent obtained from the subject.

• Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device.

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

Exclusion Criteria:

• Previous administration of the licensed MF59-containing vaccines, e.g. Fluad™ or Addigrip™ or virosome-based influenza vaccines such as Inflexal V™, InfectoVac Flu™ or Invivac™ .

• Previous administration of the 2009 Southern Hemisphere or 2008-2009 Northern Hemisphere influenza vaccine.

• Previous administration of a pandemic influenza vaccine.

• Administration of licensed vaccines within 4 weeks prior to enrolment in this study.

• Planned administration of a vaccine not foreseen by the study protocol up to 30 days after the second vaccination with H5N1 vaccine.

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

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

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

• History of hypersensitivity to vaccines.

• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.

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

• Acute disease and/or fever at the time of enrolment.

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

• Administration of immunoglobulins and/or any blood products within the three months preceding the first study vaccination or during the study.

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• GSK's candidate influenza vaccine 1562902A
Intramuscular dose on Day 0 and Day 21
• FluarixTM
Intramuscular dose on Day 42 or on Day -30, according to the vaccination schedule
• Placebo
Intramuscular dose on Day 42 or on Day -30, according to the vaccination schedule

Locations

Country	Name	City	State
Brazil	GSK Investigational Site	Curitiba/Paraná	Paraná

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum HI antibody titres		Day -30, Day 42	No
Secondary	Serum HI antibody titres		Day -30, Day 42, Month 6, Month 12	No
Secondary	Serum neutralising antibody titres		Day -30, Day 42, Month 6, Month 12	No
Secondary	Occurrence, intensity, and relationship to vaccination of solicited local and general signs and symptoms		Day 0 - Day 6 after each vaccination	No
Secondary	Occurrence, intensity and relationship to vaccination of unsolicited adverse events		Day 0 - Day 29 after vaccination, Day 0 - Day 20 after investigational vaccination	No
Secondary	Occurrence and relationship to vaccination of serious adverse events		Day 0 - Month 6	No
Secondary	Occurrence of adverse events of specific interest		Day 0 - Month 12	No