Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Monovalent Pandemic H5N1 Vaccine in Adults

NCT01416571 | Completed Phase 2 Results

• 1 other identifier: 112691
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

This trial will assess the immunogenicity and safety of GSK Biologicals' vaccine GSK1557484A, prepared from old concentrated monobulk material, in adults aged 18 to 64 years, when administered up to 5 years following production.

Conditions

Influenza

Keywords

H5N1; Influenza vaccine; influenza infection; GSK1557484A

Outcome Measures

Primary Outcomes (3)

• Number of Seroconverted Subjects Against the H5N1 Strain of Influenza Disease.

  A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer less than (\<) 1:10 and a post-vaccination reciprocal HI titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination reciprocal titer against the vaccine virus.

  At Day 42

• Mean Geometric Increase (MGI) for the H5N1 Strain of Influenza Disease.

  MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer for the vaccine virus.

  At Day 42

• Number of Seroprotected Subjects Against the H5N1 Strain of Influenza Disease.

  A seroprotected subject was defined as a vaccinated subject who had H5N1 reciprocal HI titers ≥ 1:40 against the vaccine-homologous virus.

  At Day 42

Secondary Outcomes (21)

• Number of Seropositive Subjects Against the H5N1 Strain of Influenza Disease.

  At Day 0 and Day 42

• Titers for Serum HI Antibodies Against the H5N1 Strain of Influenza Disease.

  At Day 0 and Day 42

• Number of Seropositive Subjects Against the H5N1 Strain of Influenza Disease.

  At Day 0 and Day 182

• Titers for Serum HI Antibodies Against the H5N1 Strain of Influenza Disease.

  At Day 0 and Day 182

• Number of Seroprotected Subjects Against the H5N1 Strain of Influenza Disease.

  At Day 0 and Day 182

Study Arms (1)

Influenza A (H5N1) Group

EXPERIMENTAL

Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.

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

Interventions

Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted BIOLOGICAL

Intramuscular (IM), two doses

Influenza A (H5N1) Group

Eligibility Criteria

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

You may qualify if:

• Subjects who the investigator believes can and will comply with the requirements of the protocol.
• A male or female 18 to 64 years of age at the time of the first vaccination.
• Written informed consent obtained from the subject.
• Stable general health as established by medical history and clinical examination before entering into the study.
• Subject access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
• Female subjects of non-childbearing potential may be enrolled in the study.
• Female subjects of childbearing potential may be enrolled in the study, if the subject:
• has practiced adequate contraception for 30 days prior to vaccination, and
• has a negative pregnancy test on the day of vaccination, and
• has agreed to continue adequate contraception for 2 months after completion of the vaccination series.

You may not qualify if:

• Previous vaccination at any time with an H5N1 vaccine.
• Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Presence of significant acute or chronic, uncontrolled medical or psychiatric illness.
• Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
• Presence of a temperature ≥ 38.0ºC, or acute symptoms greater than "mild" severity on the scheduled date of first dose.
• Diagnosed with cancer, or treatment for cancer, within 3 years.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Receipt of systemic glucocorticoids within 1 month prior to study enrolment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrolment. Topical, intra-articularly injected, or inhaled glucocorticoids, topical calcineurin inhibitors or imiquimod are allowed.
• Receipt of any immunoglobulins and/or any blood products within 3 months before first study vaccination or planned administration of any of these products during the study period.
• Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to dosing, are eligible. Persons receiving prophylactic antiplatelet medications, and without a clinically-apparent bleeding tendency, are eligible.
• An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine.
• Administration of an inactivated or a live, attenuated seasonal influenza vaccine within 14 days before the first study vaccine dose, or of any other vaccine(s) not foreseen by the study protocol within 30 days before the first study vaccine dose.
• Planned administration of any vaccine(s) not foreseen by the study protocol through completion of the Day 42 visit.
• Any known or suspected allergy to any constituent of influenza vaccines, or history of severe reaction to a previous influenza vaccination.
• Known pregnancy or a positive urine beta-human chorionic gonadotropin test result prior to the first study vaccine dose.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Mesa, Arizona, 85213, United States

Location

Related Publications (1)

• Godeaux O, Izurieta P, Madariaga M, Drame M, Li P, Vaughn DW. Immunogenicity and safety of AS03A-adjuvanted H5N1 influenza vaccine prepared from bulk antigen after stockpiling for 4 years. Vaccine. 2015 Apr 27;33(18):2189-95. doi: 10.1016/j.vaccine.2014.07.062. Epub 2014 Jul 30.

  PMID: 25090645 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: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2011
• First Posted: August 15, 2011
• Study Start: August 12, 2011
• Primary Completion: November 29, 2011
• Study Completion: September 28, 2012
• Last Updated: September 21, 2018
• Results First Posted: April 16, 2014

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)