Clinical trial NCT00319098: Study to Evaluate the Safety and Immunogenicity of a Pandemic Influenza Vaccine in Adults Aged 18 Years and Above
Official title: A Phase III, Observer-blind, Randomised Study to Evaluate the Safety and Immunogenicity of One and Two Administrations of Pandemic Monovalent (H5N1) Influenza Vaccine (Adjuvanted Split Virus Formulation) in Adults Aged 18 Years and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Adjuvanted pandemic influenza candidate vaccine
Influenza
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-04-27
Enrollment: 5075
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Today, the leading contender for the next pandemic of influenza is H5N1, a strain of avian virus. Prevention and control will depend on the rapid production and worldwide distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be developed and tested in clinical trials to determine the most optimal formulation and the best vaccination schedule. This study is designed to test in healthy adults aged above 18 years the reactogenicity and immunogenicity of one and two administrations of a candidate pandemic H5N1 vaccine formulated from Split Virus.

Detailed description: This study has 2 phases:

The study ID 107064 corresponds to objectives \& outcome measures evaluated from day 0 until day 51.

The study ID 107217 corresponds to objectives \& outcome measures evaluated at day 180.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
* A male or female aged 18 years or above 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, 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 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 30 days after the second vaccination.
* Administration of interpandemic influenza vaccine between Day 0 and Day 51of the study. Those study participants belonging to risk groups eligible to receive the annual interpandemic influenza vaccine (in accordance with local regulations) can receive the annual vaccination after day 51 and before the end of the study on Day 180.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first administration of the study vaccine.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
* History of chronic alcohol consumption and/or drug abuse.
* History of hypersensitivity to vaccines.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
* Major congenital defects or serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination. (Subjects suffering from seasonal allergies or asthma under inhalative treatment can be included).
* Acute disease at the time of enrolment.
* Administration of immunoglobulins and/or any blood products within the 3 months preceding the first administration of the study 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.

Primary outcomes:
measure: Number of Subjects With Solicited Local Symptoms
timeFrame: During a 7 day follow-up period after each dose of vaccine and overall.
measure: Number of Subjects With Solicited General Symptoms (Dose 1)
timeFrame: During the 7-day (Days 0-6) after Dose 1
measure: Number of Subjects With Solicited General Symptoms (Dose 2)
timeFrame: During the 7-day (Days 0-6) after Dose 2
measure: Number of Subjects With Solicited General Symptoms (Across Doses)
timeFrame: During the 7-day (Days 0-6) post vaccination across dosses
measure: Number of Subjects With Unsolicited Adverse Events (AEs)
timeFrame: During the 21st Day (Days 0-20) post Dose 1
measure: Number of Subjects With AEs
timeFrame: During the 30 Day (Days 0-29) post Dose 2
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: From Day 0 to Day 180
measure: Number of Subjects With New Onset Chronic Diseases (NOCDs)
timeFrame: From Day 0 to Day 180
measure: Number of Subjects With Medically Significant Conditions (MSCs)
timeFrame: From Day 0 to Day 51
Secondary outcomes:
measure: Anti- Haemagglutinin Antibody (Anti-HA) Titers Against Avian Influenza A Subtype H5N1
timeFrame: At Day 0 (PRE), 21 and 42
measure: Number of Seroconverted Subjects Against H5N1
timeFrame: At Day 21 and Day 42
measure: Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam Influenza Strain
timeFrame: At Day 21 and Day 42
measure: Number of Seroprotected Subjects Against A/Vietnam Influenza Strain
timeFrame: At Day 0 (PRE), Day 21 and Day 42
Other outcomes:
Locations:
city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Tartu
country: Estonia
facility: GSK Investigational Site
city: Caen cedex 4
country: France
facility: GSK Investigational Site
city: Lagord
country: France
facility: GSK Investigational Site
city: Nantes
country: France
facility: GSK Investigational Site
city: Paris Cedex 18
country: France
facility: GSK Investigational Site
city: Poitiers
country: France
facility: GSK Investigational Site
city: Rouen
country: France
facility: GSK Investigational Site
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Regensburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Wuerzburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Schwerin
country: Germany
facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
city: Hannover
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Witten
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Rotterdam
country: Netherlands
facility: GSK Investigational Site
city: Rotterdam
country: Netherlands
facility: GSK Investigational Site
city: Ekaterinburg
country: Russian Federation
facility: GSK Investigational Site
city: Ekaterinburg
country: Russian Federation
facility: GSK Investigational Site
city: Kazan
country: Russian Federation
facility: GSK Investigational Site
city: Novokuznetsk
country: Russian Federation
facility: GSK Investigational Site
city: Saratov
country: Russian Federation
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Marid
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Eskilstuna
country: Sweden
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Rumke HC, Bayas JM, de Juanes JR, Caso C, Richardus JH, Campins M, Rombo L, Duval X, Romanenko V, Schwarz TF, Fassakhov R, Abad-Santos F, von Sonnenburg F, Drame M, Sanger R, Ballou WR. Safety and reactogenicity profile of an adjuvanted H5N1 pandemic candidate vaccine in adults within a phase III safety trial. Vaccine. 2008 May 2;26(19):2378-88. doi: 10.1016/j.vaccine.2008.02.068. Epub 2008 Mar 27.