Safety and Immunogenicity of H1N1 Vaccines in Adults Aged 18 Years and Older

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00985088
First received: September 24, 2009
Last updated: November 17, 2011
Last verified: June 2011
  Purpose

The purpose of this study is to characterize the safety and immunogenicity of the H1N1 (swine) flu vaccines GSK2340273A and GSK2340274A in adults 18 years of age or older.

This protocol posting has been updated for sections impacted by the Protocol amendment 1, Sept 2009.


Condition Intervention Phase
Influenza Infection
Biological: GSK2340274A
Biological: GSK2340273A
Biological: Saline placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Study to Evaluate the Safety and Immunogenicity of A/California/7/2009 (H1N1)V-like Vaccines GSK2340273A and GSK2340274A in Adults Aged 18 Years and Older

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Evaluation of the humoral immune response of subjects in Groups A, C, B1 and B2 [ Time Frame: Days 0 and 21 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vaccine virus-homologous HI antibody response of subjects in Groups A, C, B1 and B2 [ Time Frame: Days 0, 21, 42, and 182 ] [ Designated as safety issue: No ]
  • Vaccine virus-homologous HI antibody response of subjects in Groups D, E1, E2 and F [ Time Frame: Days 0, 21, 42, and 182 ] [ Designated as safety issue: No ]
  • Vaccine virus heterologous HI antibody response for a subcohort of subjects in each Group (A - F) [ Time Frame: Days 0, 21, 42, and 182 ] [ Designated as safety issue: No ]
  • Vaccine virus-homologous and heterologous microneutralization antibody response for a subcohort of subjects in each Group (A - F) [ Time Frame: Days 0, 21, 42, and 182 ] [ Designated as safety issue: No ]
  • Occurrence of solicited local and general symptoms [ Time Frame: During a 7-day (Day 0-6) follow-up period after each dose of vaccine ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events [ Time Frame: During a 21-day (Day 0-20) follow-up period after each dose and from Days 0 -to 84 ] [ Designated as safety issue: No ]
  • Clinical laboratory abnormalities [ Time Frame: Days 0, 7, 21, 28, 42 and 182 ] [ Designated as safety issue: No ]
  • Occurrence of medically attended and/or serious adverse events, and of potentially immune-mediated diseases [ Time Frame: Days 0 to 385 ] [ Designated as safety issue: No ]

Enrollment: 1343
Study Start Date: October 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Subjects in this group will receive investigational vaccine regimen according to a protocol specified schedule different from Group B1, Group B2, Group C, Group D, Group E1, Group E2, and Group F
Biological: GSK2340274A
one or two intramuscular injections
Experimental: Group B1
Subjects in this group will receive investigational vaccine regimen according to a protocol specified schedule different from Group A, Group B2, Group C and Group D, Group E, Group E2, Group F
Biological: GSK2340274A
one or two intramuscular injections
Experimental: Group B2
Subjects in this group will receive investigational vaccine regimen according to a protocol specified schedule different from Group A, Group B1, Group C and Group D, Group E1, Group E2, Group F
Biological: GSK2340274A
one or two intramuscular injections
Biological: Saline placebo
One injection
Experimental: Group C
Subjects in this group will receive investigational vaccine regimen according to a protocol specified schedule different from Group A, Group B1, Group B2, and Group D, Group E1, Group E2, Group F
Biological: GSK2340274A
one or two intramuscular injections
Biological: Saline placebo
One injection
Experimental: Group D
Subjects in this group will receive investigational vaccine regimen according to a protocol specified schedule different from Group A, Group B1, Group B2, and Group C, Group E1, Group E2, Group F
Biological: GSK2340273A
one or two intramuscular injections
Biological: Saline placebo
One injection
Experimental: Group E1
Subjects in this group will receive investigational vaccine regimen according to a protocol specified schedule different from Group A, Group B1, Group B2, and Group C, Group D, Group E2, Group F
Biological: GSK2340273A
one or two intramuscular injections
Experimental: Group E2
Subjects in this group will receive investigational vaccine regimen according to a protocol specified schedule different from Group A, Group B1, Group B2, and Group C, Group D, Group E1, Group F
Biological: GSK2340273A
one or two intramuscular injections
Biological: Saline placebo
One injection
Experimental: Group F
Subjects in this group will receive investigational vaccine regimen according to a protocol specified schedule different from Group A, Group B1, Group B2, and Group C, Group D, Group E1, Group E2, Group F
Biological: GSK2340273A
one or two intramuscular injections

Detailed Description:

Collaborators: United States Department of Health and Human Services, Office of Biomedical Advanced Research and Development Authority

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the subject.
  • Male and female adults, >= 18 years of age at the time of the first vaccination.
  • Safety laboratory test results within the parameters specified in the protocol.
  • Satisfactory baseline medical assessment by history and physical examination.
  • Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits as documented by signature on the informed consent document.
  • 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.
  • 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 first vaccination, and
  • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

  • Medical history of physician-confirmed infection with an A/California/7/2009 (H1N1)v-like virus
  • Previous vaccination at any time with an H1N1v-like virus vaccine or a medical history of physician-confirmed infection with an H1N1v-like virus.
  • 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 (>=100.4ºF), or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
  • 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 (no laboratory testing required).
  • Receipt of systemic glucocorticoids within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. 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 of study enrollment 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 vaccination, are eligible. Persons receiving prophylactic antiplatelet medications, e.g., low-dose acetylsalicylic acid, 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
  • With the exception of seasonal influenza vaccination, administration of any vaccine(s) within 30 days before study vaccination on Day 0. Seasonal influenza vaccine may be administered up to 14 days prior to study vaccination on Day 0.
  • Planned administration of any vaccine not foreseen by the study protocol between Day 0 and the Day 42 phlebotomy, including seasonal influenza vaccine or a monovalent pandemic H1N1 vaccine other than the study vaccines.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine/product, or planned use during the study period.
  • Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; 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 first vaccination.
  • Lactating or nursing women.
  Contacts and Locations
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: NCT00985088

Locations
United States, Alabama
GSK Investigational Site
Huntsville, Alabama, United States, 35802
United States, Florida
GSK Investigational Site
Jacksonville, Florida, United States, 32216
GSK Investigational Site
Miami, Florida, United States, 33143
United States, Idaho
GSK Investigational Site
Meridian, Idaho, United States, 83642
United States, Kansas
GSK Investigational Site
Lenexa, Kansas, United States, 66219
United States, Montana
GSK Investigational Site
Missoula, Montana, United States, 59801
United States, Nevada
GSK Investigational Site
Las Vegas, Nevada, United States, 89104
United States, New Jersey
GSK Investigational Site
Edison, New Jersey, United States, 08817
United States, New York
GSK Investigational Site
Rochester, New York, United States, 14609
United States, Ohio
GSK Investigational Site
Cleveland, Ohio, United States, 44122
Canada, British Columbia
GSK Investigational Site
Surrey, British Columbia, Canada, V3R 8P8
Canada, Nova Scotia
GSK Investigational Site
Truro, Nova Scotia, Canada, B2N 1L2
Canada, Ontario
GSK Investigational Site
Toronto, Ontario, Canada, M9W 4L6
Canada, Quebec
GSK Investigational Site
Pointe-Claire, Quebec, Canada, H9R 4S3
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Ferguson M et al. Immunogenicity and safety of an H1N1 2009 pandemic influenza vaccine administered to adults with or without AS03 adjuvant: results of a randomized, dose-ranging study. Abstract presented at the Options for the Control of Influenza VII Conference. Hong Kong SAR, China, 3-7 September 2010.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00985088     History of Changes
Other Study ID Numbers: 113440
Study First Received: September 24, 2009
Last Updated: November 17, 2011
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
GSK Bio's influenza vaccine GSK2340274A
influenza infection
GSK Bio's influenza vaccine GSK2340273A

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 26, 2014