A Study for Evaluation of GSK Biologicals' Pandemic Influenza Vaccine.
This study has been completed.
Information provided by:
First received: December 18, 2008
Last updated: September 9, 2009
Last verified: September 2009
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.
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
||Non-inferiority Study of GSK Biologicals' Pandemic Influenza Vaccine 1562902A.
Primary Outcome Measures:
- Serum HI antibody titres [ Time Frame: Day 42 ] [ Designated as safety issue: No ]
- Geometric mean titres (GMTs) of HI antibody titres [ Time Frame: Day 42 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Serum HI antibody titres [ Time Frame: Day 0, Day 42 and Day 180 ] [ Designated as safety issue: No ]
- GMTs of HI antibody titres [ Time Frame: Day 0 and Day 180 ] [ Designated as safety issue: No ]
- Seropositivity of HI antibody titres [ Time Frame: Day 42 ] [ Designated as safety issue: No ]
- Seroconversion rates for HI antibodies [ Time Frame: Day 42 and Day 180 ] [ Designated as safety issue: No ]
- Seroconversion factors for HI antibodies [ Time Frame: Day 42 and Day 180 ] [ Designated as safety issue: No ]
- Seroprotection rates for HI antibodies [ Time Frame: Day 0, Day 42 and Day 180 ] [ Designated as safety issue: No ]
- Serum neutralising antibody titres [ Time Frame: Day 0, Day 42 and Day 180 ] [ Designated as safety issue: No ]
- GMTs of neutralising antibody titres [ Time Frame: Day 0, Day 42 and Day 180 ] [ Designated as safety issue: No ]
- Seroconversion rates for neutralising antibodies [ Time Frame: Day 42 and Day 180 ] [ Designated as safety issue: No ]
- Percentage, intensity, and relationship to vaccination of solicited local and general signs and symptoms [ Time Frame: Day 0 - Day 6 after each vaccination ] [ Designated as safety issue: No ]
- Percentage, intensity and relationship to vaccination of unsolicited local and general signs and symptoms [ Time Frame: Day 0 - Day 30 after second vaccination ] [ Designated as safety issue: No ]
- Occurrence of unsolicited adverse events [ Time Frame: Day 0 - Day 51 ] [ Designated as safety issue: No ]
- Occurrence of adverse events of specific interest [ Time Frame: Day 0 - Day 180 ] [ Designated as safety issue: No ]
- Occurrence of serious adverse events [ Time Frame: Day 0 - Day 180 ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2009 (Final data collection date for primary outcome measure)
Experimental: Group A
Experimental: Group B
|Ages Eligible for Study:
||18 Years to 59 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00812981
|GSK Investigational Site
|Taipei, Taiwan, 100 |
||GSK Clinical Trials
No publications provided by GlaxoSmithKline
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
||Study Director, GSK
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 18, 2008
||September 9, 2009
||Taiwan: Department of Health
Keywords provided by GlaxoSmithKline:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 25, 2014
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections