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A Study for Evaluation of GSK Biologicals' Pandemic Influenza Vaccine.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00812981
First Posted: December 22, 2008
Last Update Posted: June 16, 2017
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.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
This observer-blind study is designed to show the immunological non-inferiority of Thiomersal-free-processed pandemic influenza vaccine as compared to the Thiomersal-containing-processed pandemic influenza vaccine.

Condition Intervention Phase
Influenza Biological: GSK1562902A Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Non-inferiority Study of GSK Biologicals' Pandemic Influenza Vaccine 1562902A.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Titers for Serum H5N1 Haemagglutination-inhibition (HI) Antibodies [ Time Frame: At Day 42 ]
    Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was A/Indonesia/05/2005.


Secondary Outcome Measures:
  • Titers for Serum H5N1 HI Antibodies [ Time Frame: At Day 0 and Day 180 ]
    Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.

  • Number of Subjects With H5N1 HI Antibody Concentrations Above the Cut-off Value [ Time Frame: At Days 0, 42 and 180 ]
    The cut-off values for the humoral immune response in terms of H5N1 HI antibodies were equal to or above (≥) 1:10. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.

  • Number of Seroconverted Subjects Against Two Strains of Influenza Disease [ Time Frame: At Day 42 and Day 180 ]
    A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer below (<) 1:10 and a post-vaccination titer equal to or above (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.

  • Seroconversion Factor (SCF) for H5N1 HI Antibodies [ Time Frame: At Day 42 and Day 180 ]
    The seroconversion factor (SCF) was defined as the fold increase in H5N1 HI antibody GMTs post-vaccination compared to Day 0. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.

  • Number of Seroprotected Subjects for H5N1 HI Antibodies [ Time Frame: At Days 0, 42 and 180 ]
    A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.

  • Titers for Serum Neutralising Antibodies Against A/Vietnam/1194/2004 Strain of Influenza Disease [ Time Frame: At Days 0, 42 and 180 ]
    Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:28. The flu strain assessed was A/Vietnam/1194/2004.

  • Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value [ Time Frame: At Days 0, 42 and 180 ]
    Seropositivity cut-off values assessed were equal to or above (≥) 1:28 in the sera of subjects seronegative before vaccination. The flu strain assessed was A/Vietnam/1194/2004.

  • Number of Seroconverted Subjects for Neutralizing Antibodies [ Time Frame: At Day 42 and Day 180 ]
    A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:28 and a post-vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:28 and at least a four-fold increase in post-vaccination titer. The flu strain assessed was A/Vietnam/1194/2004.

  • 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 ]
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

  • 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 ]
    Assessed solicited general symptoms were arthralgia, fatigue, headache, myalgia, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.

  • Number of Subjects With Any Adverse Events of Specific Interest (AESIs) [ Time Frame: From Day 0 up to 51 days after the first vaccination ]
    An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.

  • Number of Subjects With Any AESIs [ Time Frame: During the entire study period (from Day 0 up to Day 180) ]
    An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.

  • Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [ Time Frame: During the 21-day follow-up period after the first vaccination and 30-day follow-up period after the second vaccination ]
    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.

  • Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [ Time Frame: During the entire study period (from Day 0 up to Day 180) ]
    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.

  • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: From Day 0 up to Day 51 ]
    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 SAEs [ Time Frame: During the entire study period (from Day 0 up 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.


Enrollment: 320
Actual Study Start Date: November 15, 2008
Study Completion Date: June 7, 2009
Primary Completion Date: June 7, 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1562902A NP GROUP
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
Biological: GSK1562902A
new-processed (NP), administered intramuscularly in the deltoid region of the non-dominant arm
Experimental: 1562902A CP GROUP
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
Biological: GSK1562902A
comparative-processed (CP), administered intramuscularly in the deltoid region of the non-dominant arm

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 aged 18 to 60 years at the time of the first vaccination.
  • Written informed consent obtained from the subject.
  • Good general health as established by medical history and clinical examination before entering into the study.
  • 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
  • Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of short- and long-term safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits.
  • If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.

Exclusion Criteria:

  • Evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
  • Diagnosed with cancer, or treatment for cancer, within 3 years.
  • An oral temperature ≥ 37.8 º C or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
  • Receipt of systemic glucocorticoids (prednisone ≥ 5 mg/kg/day for more than 14 consecutive days) within 1 month of study enrolment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrolment.
  • Any significant disorder of coagulation or treatment with Coumarin derivatives or Heparin.
  • Administration of any vaccines within 30 days before study enrolment.
  • Previous administration of any H5N1 vaccine.
  • Previous administration of vaccines with adjuvants similar to those used in the investigational vaccine.
  • Use of any investigational or non-registered product (drug or vaccine) or planned participation in another investigational study within 30 days prior to study enrolment, or during the 180 days following the first test article dose. Use of any investigational or non-registered product with immunosuppressive properties is exclusionary at any time during the trial.
  • Receipt of any immunoglobulins and/or any blood products within 3 months of study enrolment or planned administration of any of these products during the study period.
  • Any known or suspected allergy to any constituent of influenza vaccines (including egg proteins or mercurial preservatives); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
  • Known pregnancy or a positive urine beta-human chorionic gonadotropin (β-hCG) test result prior to either vaccination.
  • Lactating women.
  • Women of child bearing potential who lack a history of reliable contraceptive practices. The provision of this history does NOT replace the requirement to perform, and obtain negative results in pregnancy urine tests prior to treatments.
  • Known use of an analgesic or antipyretic medication within 12 hours prior to first treatment.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00812981


Locations
Taiwan
GSK Investigational Site
Taipei, Taiwan, 100
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 111954
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 111954
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 111954
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 111954
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 111954
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 111954
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 111954
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00812981     History of Changes
Other Study ID Numbers: 111954
First Submitted: December 18, 2008
First Posted: December 22, 2008
Results First Submitted: March 29, 2017
Results First Posted: June 16, 2017
Last Update Posted: June 16, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
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.

Keywords provided by GlaxoSmithKline:
Pandemic influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs