Immunogenicity and Safety of GSK Biologicals' (Pre-) Pandemic Influenza Candidate Vaccine

NCT00742885 | Completed Phase 2 Results

• 1 other identifier: 111756
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

This trial will assess the immunogenicity and safety elicited by the adjuvanted GSK Biologicals' (pre-) pandemic influenza candidate vaccine in healthy Japanese adults.

Conditions

Influenza

Keywords

Immunogenicity; Safety; Pandemic Influenza

Outcome Measures

Primary Outcomes (5)

• Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain

  Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Indonesia/05/2005 antigen (A/Indonesia).

  At Day 0 and Day 42

• Number of Subjects Seroconverted for H5N1 HI Antibodies

  A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The H5N1 vaccine strain included A/Indonesia antigen.

  At Day 42

• HI Antibody Seroconversion Factors for H5N1 HI Antibodies

  Seroconversion factors (SCF) were defined as the fold increase in serum H5N1 HI antibody GMTs post-vaccination compared to Day 0, at Day 42. The H5N1 vaccine strain included A/Indonesia antigen.

  At Day 0 and Day 42

• Number of Subjects Seroprotected for H5N1 HI Antibodies

  A seroprotected subject was defined as a subject with a serum H5N1 HI antibody titer greater than or equal to 1:40, at Day 42. The H5N1 vaccine strain included A/Indonesia antigen.

  At Day 42

• Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain

  Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Indonesia antigen.

  At Day 0, Day 21 and Day 182

Secondary Outcomes (15)

• Number of Subjects Seroconverted for H5N1 HI Antibodies

  At Day 21 and Day 182

• Seroconversion Factors for H5N1 HI Antibodies

  At Day 21 and Day 182

• Number of Subjects Seroprotected for H5N1 HI Antibodies

  At Day 0, Day 21 and Day 182

• Antibody Titers for Serum Anti-H5N1 Neutralising Antibodies

  At Day 0, Day 42 and Day 182

• Number of Subjects Seroconverted for Serum Anti-H5N1 Neutralising Antibodies

  At Day 42 and Day 182

Study Arms (2)

Influenza A (H5N1) 20-40 Years Group

EXPERIMENTAL

Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.

Biological: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted

Influenza A (H5N1) 41-64 Years Group

EXPERIMENTAL

Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.

Biological: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted

Interventions

Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted BIOLOGICAL

All subjects will receive 2 doses administered as an intramuscular (IM) injection.

Also known as: PumarixTM

Influenza A (H5N1) 20-40 Years Group; Influenza A (H5N1) 41-64 Years Group

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Japanese male and female adults 20 to 64 years of age at time of the first vaccination, inclusive.
• Good general health as assessed by medical history and physical examination.
• 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.
• Written informed consent obtained from the subject.
• Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.
• Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.

You may not qualify if:

• Presence of significant acute or chronic, uncontrolled medical or psychiatric illness.
• Presence or evidence of substance abuse or of neurological or psychiatric diagnoses which, although 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.
• Presence of an axillary temperature \>= 37.5 °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 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 Coumadin derivatives or heparin.
• Administration of any registered vaccine within 30 days before study enrolment or planned administration within the first vaccination up to blood sampling at Day 42 and within 30 days prior to blood sampling at Day 182.
• Use of any investigational or non-registered product within 30 days prior to study enrolment or planned use during the study period.
• History of previous H5N1 vaccination, or history of H5N1 influenza infection.
• Receipt of any immunoglobulins and/or any blood products within 6 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 or component used in the manufacturing process of the study vaccine, 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 test result prior to the time of first vaccination.
• Lactating or nursing.
• 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; all women will have urine pregnancy tests regardless of their status.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Fukuoka, 813-8588, Japan

Location

GSK Investigational Site

Tokyo, 204-8585, Japan

Location

Related Publications (1)

• Nagai H, Ikematsu H, Tenjinbaru K, Maeda A, Drame M, Roman FP. A phase II, open-label, multicentre study to evaluate the immunogenicity and safety of an adjuvanted prepandemic (H5N1) influenza vaccine in healthy Japanese adults. BMC Infect Dis. 2010 Nov 25;10:338. doi: 10.1186/1471-2334-10-338.

  PMID: 21108818 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 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2008
• First Posted: August 28, 2008
• Study Start: September 1, 2008
• Primary Completion: March 7, 2009
• Study Completion: March 7, 2009
• Last Updated: August 20, 2018
• Results First Posted: February 24, 2014

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

JP (2)