Study to Evaluate the Safety and Immunogenicity of a Pandemic Influenza Vaccine in Adults Aged 18 Years and Above

NCT00319098 | Completed Phase 3 Results

• 2 other identifiers: 107064107217
• Study Type: interventional
• Target: 5,075
• Locations: 6 countries
• Sites: 32

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.

Conditions

Influenza

Keywords

Adjuvanted pandemic influenza candidate vaccine; Influenza

Outcome Measures

Primary Outcomes (9)

• Number of Subjects With Solicited Local Symptoms

  Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of symptom regardless of intensity grade. Grade 3 Pain = pain that prevented normal everyday activities Grade 3 ecchymosis/induration/redness/swelling = redness/swelling spreading beyond (\>) 50 millimeters (mm) in diameter

  During a 7 day follow-up period after each dose of vaccine and overall.

• Number of Subjects With Solicited General Symptoms (Dose 1)

  Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (\>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination.

  During the 7-day (Days 0-6) after Dose 1

• Number of Subjects With Solicited General Symptoms (Dose 2)

  Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (\>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination.

  During the 7-day (Days 0-6) after Dose 2

• Number of Subjects With Solicited General Symptoms (Across Doses)

  Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (\>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination.

  During the 7-day (Days 0-6) post vaccination across dosses

• Number of Subjects With Unsolicited Adverse Events (AEs)

  An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. Related symptoms were not available.

  During the 21st Day (Days 0-20) post Dose 1

• Number of Subjects With AEs

  An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. Related symptoms were not available.

  During the 30 Day (Days 0-29) post Dose 2

• Number of Subjects With Serious Adverse Events (SAEs)

  SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  From Day 0 to Day 180

• Number of Subjects With New Onset Chronic Diseases (NOCDs)

  NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.

  From Day 0 to Day 180

• Number of Subjects With Medically Significant Conditions (MSCs)

  MSCs prompting emergency room or physician visits that were not related to common diseases or routine visits. Common diseases included upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.

  From Day 0 to Day 51

Secondary Outcomes (4)

• Anti- Haemagglutinin Antibody (Anti-HA) Titers Against Avian Influenza A Subtype H5N1

  At Day 0 (PRE), 21 and 42

• Number of Seroconverted Subjects Against H5N1

  At Day 21 and Day 42

• Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam Influenza Strain

  At Day 21 and Day 42

• Number of Seroprotected Subjects Against A/Vietnam Influenza Strain

  At Day 0 (PRE), Day 21 and Day 42

Study Arms (2)

GSK1562902A Group

EXPERIMENTAL

Male and female subjects aged 18 or over received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm. The group was further stratified by age for analyses.

Biological: Adjuvanted pandemic influenza candidate vaccine

Fluarix+Placebo Group

ACTIVE COMPARATOR

Male and female subjects aged 18 or over received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm. The group was further stratified by age for analyses.

Biological: Fluarix; Biological: Placebo

Interventions

Adjuvanted pandemic influenza candidate vaccine BIOLOGICAL

2 doses, intramuscular injection

GSK1562902A Group

Fluarix BIOLOGICAL

One intramuscular injection

Fluarix+Placebo Group

Placebo BIOLOGICAL

One intramuscular injection

Fluarix+Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (40)

GSK Investigational Site

Tallinn, 10617, Estonia

Location

GSK Investigational Site

Tartu, 50417, Estonia

Location

GSK Investigational Site

Caen, 14052, France

Location

GSK Investigational Site

Lagord, 17140, France

Location

GSK Investigational Site

Nantes, 44093, France

Location

GSK Investigational Site

Paris, 75877, France

Location

GSK Investigational Site

Poitiers, 86000, France

Location

GSK Investigational Site

Rouen, 76100, France

Location

GSK Investigational Site

Munich, Bavaria, 80799, Germany

Location

GSK Investigational Site

Munich, Bavaria, 81667, Germany

Location

GSK Investigational Site

Regensburg, Bavaria, 93053, Germany

Location

GSK Investigational Site

Würzburg, Bavaria, 97070, Germany

Location

GSK Investigational Site

Hanover, Lower Saxony, 30519, Germany

Location

GSK Investigational Site

Schwerin, Mecklenburg-Vorpommern, 19055, Germany

Location

GSK Investigational Site

Witten, North Rhine-Westphalia, 58455, Germany

Location

GSK Investigational Site

Dresden, Saxony, 01067, Germany

Location

GSK Investigational Site

Leipzig, Saxony, 04103, Germany

Location

GSK Investigational Site

Leipzig, Saxony, 04229, Germany

Location

GSK Investigational Site

Berlin, 10117, Germany

Location

GSK Investigational Site

Berlin, 10787, Germany

Location

GSK Investigational Site

Berlin, 14057, Germany

Location

GSK Investigational Site

Hamburg, 20249, Germany

Location

GSK Investigational Site

Hamburg, 22143, Germany

Location

GSK Investigational Site

Rotterdam, 3011 EN, Netherlands

Location

GSK Investigational Site

Rotterdam, 3015 GE, Netherlands

Location

GSK Investigational Site

Kazan', 420015, Russia

Location

GSK Investigational Site

Novokuznetsk, 654063, Russia

Location

GSK Investigational Site

Saratov, Russia

Location

GSK Investigational Site

Yekaterinburg, 620028, Russia

Location

GSK Investigational Site

Yekaterinburg, 620078, Russia

Location

GSK Investigational Site

Barcelona, 08035, Spain

Location

GSK Investigational Site

Barcelona, 08036, Spain

Location

GSK Investigational Site

Madrid, 28006, Spain

Location

GSK Investigational Site

Madrid, 28040, Spain

Location

GSK Investigational Site

Madrid, 28041, Spain

Location

GSK Investigational Site

Marid, 28040, Spain

Location

GSK Investigational Site

Valencia, 46014, Spain

Location

GSK Investigational Site

Valencia, 46017, Spain

Location

GSK Investigational Site

Eskilstuna, SE-631 88, Sweden

Location

GSK Investigational Site

Stockholm, SE-141 86, Sweden

Location

Related Publications (1)

• 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.

  PMID: 18407382 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Influenza, Human

Interventions

fluarix

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2006
• First Posted: April 27, 2006
• Study Start: May 1, 2006
• Primary Completion: January 1, 2007
• Study Completion: July 31, 2007
• Last Updated: July 23, 2018
• Results First Posted: August 3, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

NL (2); RU (5); SE (2); FR (6); DE (15); ES (2)