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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00319098
Recruitment Status : Completed
First Posted : April 27, 2006
Results First Posted : August 3, 2017
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE April 26, 2006
First Posted Date  ICMJE April 27, 2006
Results First Submitted Date  ICMJE January 31, 2017
Results First Posted Date  ICMJE August 3, 2017
Last Update Posted Date July 23, 2018
Actual Study Start Date  ICMJE May 1, 2006
Actual Primary Completion Date January 1, 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2017)
  • Number of Subjects With Solicited Local Symptoms [ Time Frame: During a 7 day follow-up period after each dose of vaccine and overall. ]
    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
  • Number of Subjects With Solicited General Symptoms (Dose 1) [ Time Frame: During the 7-day (Days 0-6) after 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.
  • Number of Subjects With Solicited General Symptoms (Dose 2) [ Time Frame: During the 7-day (Days 0-6) after 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.
  • Number of Subjects With Solicited General Symptoms (Across Doses) [ Time Frame: During the 7-day (Days 0-6) post vaccination across dosses ]
    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.
  • Number of Subjects With Unsolicited Adverse Events (AEs) [ Time Frame: During the 21st Day (Days 0-20) post Dose 1 ]
    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.
  • Number of Subjects With AEs [ Time Frame: During the 30 Day (Days 0-29) post Dose 2 ]
    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.
  • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: From Day 0 to Day 180 ]
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
  • Number of Subjects With New Onset Chronic Diseases (NOCDs) [ Time Frame: From Day 0 to Day 180 ]
    NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.
  • Number of Subjects With Medically Significant Conditions (MSCs) [ Time Frame: From Day 0 to Day 51 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 26, 2006)
  • To evaluate the safety and reactogenicity of the study vaccines in term of solicited local and general adverse events, unsolicited adverse events and serious adverse events
  • To evaluate the occurrence of new onset of chronic disease
  • To evaluate the occurrence of medically significant conditions prompting emergency room visits or physician visits
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2017)
  • Anti- Haemagglutinin Antibody (Anti-HA) Titers Against Avian Influenza A Subtype H5N1 [ Time Frame: At Day 0 (PRE), 21 and 42 ]
    Anti-HA antibody titers were expressed as Geometric Mean Tiyers (GMTs).
  • Number of Seroconverted Subjects Against H5N1 [ Time Frame: At Day 21 and Day 42 ]
    Seroconversion rate for Haemagglutinin antibody response was defined as the number of vaccinees who had either a pre-vaccination titer lower than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a fourfold increase in post-vaccination titer. Seroconversion rate for Neutralising antibody response was defined as the percentage of vaccinees with a minimum 4-fold increase in titer at post-vaccination.
  • Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam Influenza Strain [ Time Frame: At Day 21 and Day 42 ]
    Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to day 0.
  • Number of Seroprotected Subjects Against A/Vietnam Influenza Strain [ Time Frame: At Day 0 (PRE), Day 21 and Day 42 ]
    Seroprotection rate was defined as the number of vaccinees with a serum HI titer ≥1:40 that usually is accepted as indicating protection.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2006)
To evaluate the humoral immune response induced by the study vaccines in terms of anti-haemagglutinin antibody and neutralizing antibody titers 21 days after each vaccination and 180 days after the first one.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Safety and Immunogenicity of a Pandemic Influenza Vaccine in Adults Aged 18 Years and Above
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Influenza
Intervention  ICMJE
  • Biological: Adjuvanted pandemic influenza candidate vaccine
    2 doses, intramuscular injection
  • Biological: Fluarix
    One intramuscular injection
  • Biological: Placebo
    One intramuscular injection
Study Arms  ICMJE
  • Experimental: GSK1562902A Group
    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.
    Intervention: Biological: Adjuvanted pandemic influenza candidate vaccine
  • Active Comparator: Fluarix+Placebo Group
    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.
    Interventions:
    • Biological: Fluarix
    • Biological: Placebo
Publications * Rümke 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, Dramé M, Sänger 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 10, 2011)
5075
Original Enrollment  ICMJE
 (submitted: April 26, 2006)
5052
Actual Study Completion Date  ICMJE July 31, 2007
Actual Primary Completion Date January 1, 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Estonia,   France,   Germany,   Netherlands,   Russian Federation,   Spain,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00319098
Other Study ID Numbers  ICMJE 107064
107217 ( Other Identifier: GSK )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP