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

NCT00812981 | Completed Phase 3 Results

• 1 other identifier: 111954
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Influenza

Keywords

Pandemic influenza

Outcome Measures

Primary Outcomes (1)

• Titers for Serum H5N1 Haemagglutination-inhibition (HI) Antibodies

  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.

  At Day 42

Secondary Outcomes (16)

• Titers for Serum H5N1 HI Antibodies

  At Day 0 and Day 180

• Number of Subjects With H5N1 HI Antibody Concentrations Above the Cut-off Value

  At Days 0, 42 and 180

• Number of Seroconverted Subjects Against Two Strains of Influenza Disease

  At Day 42 and Day 180

• Seroconversion Factor (SCF) for H5N1 HI Antibodies

  At Day 42 and Day 180

• Number of Seroprotected Subjects for H5N1 HI Antibodies

  At Days 0, 42 and 180

Study Arms (2)

1562902A NP GROUP

EXPERIMENTAL

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

1562902A CP GROUP

EXPERIMENTAL

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

Interventions

GSK1562902A BIOLOGICAL

new-processed (NP), administered intramuscularly in the deltoid region of the non-dominant arm

1562902A NP GROUP

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Taipei, 100, Taiwan

Location

Related Publications (1)

• Yang PC, Yu CJ, Chang SC, Hsieh SM, Drame M, Walravens K, Roman F, Gillard P. Safety and immunogenicity of a split-virion AS03A-adjuvanted A/Indonesia/05/2005 (H5N1) vaccine in Taiwanese adults. J Formos Med Assoc. 2012 Jun;111(6):333-9. doi: 10.1016/j.jfma.2011.02.006. Epub 2012 Apr 20.

  PMID: 22748624 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

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: December 18, 2008
• First Posted: December 22, 2008
• Study Start: November 15, 2008
• Primary Completion: June 7, 2009
• Study Completion: June 7, 2009
• Last Updated: August 20, 2018
• Results First Posted: June 16, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

TW (1)