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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00979602
First received: September 17, 2009
Last updated: July 11, 2013
Last verified: January 2012
  Purpose

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


Condition Intervention Phase
Influenza Infection
Biological: GSK2340274A
Biological: GSK2340273A
Phase 3

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, Immunogenicity, and Relative Efficacy of A/California/7/2009 (H1N1)V-like Vaccines GSK2340274A and GSK2340273A in Adults Aged 18 Years and Older

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Vaccine virus-homologous HI antibody response of subjects in Group A [ Time Frame: Day 0 and 21 days after the first dose ] [ Designated as safety issue: No ]
  • Number of Quantitative Reverse Transcription Polymerase Chain Reaction Assay (RT-qPCR)-confirmed H1N1 (swine) influenza like illness cases in Group A versus Group B [ Time Frame: From 14 days after the first Day 0 visit (in each country conducting the study) until 360 RT-qPCR-confirmed H1N1 (swine) influenza like illness cases or Day 385 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vaccine virus- homologous HI antibody response in Group B [ Time Frame: Days 0 and 21 after the first dose ] [ Designated as safety issue: No ]
  • Vaccine virus- homologous HI antibody response in Groups A and B [ Time Frame: Days 42 (in a subcohort of subjects) and 182 (all subjects) ] [ Designated as safety issue: No ]
  • Vaccine virus -homologous and heterologous microneutralization antibody response; vaccine virus-heterologous HI response in a subcohort of subjects in Groups A and B [ Time Frame: Days 0, 21, 42, and 182 ] [ Designated as safety issue: No ]
  • Number of RT-qPCR-confirmed H1N1 (swine) influenza like illness cases in Group A versus Group B [ Time Frame: From Day 0 until 360 H1N1 (swine) influenza cases have been identified or study conclusion on Day 385 ] [ Designated as safety issue: No ]
  • Number of culture-confirmed H1N1 (swine) influenza cases in Group A versus Group B [ Time Frame: From Day 0 until 360 H1N1 (swine) influenza cases identified or Day 385 and from 14 days after first Day 0 visit (in each country where the study is conducted), until 360 H1N1 (swine) influenza cases identified or Day 385 ] [ Designated as safety issue: No ]
  • Total number of influenza-like illness cases per Group (A versus B) [ Time Frame: From Day 0 until 360 H1N1 (swine) influenza cases identified or Day 385; and from 14 days after first Day 0 visit (in each country where the study is conducted),, until 360 H1N1 (swine) influenza cases identified or Day 385 ] [ Designated as safety issue: No ]
  • Total number of laboratory-confirmed H1N1 (swine) influenza cases with pneumonia per treatment group [ Time Frame: From Day 0 until 360 H1N1 (swine) influenza cases identified or Day 385; and from 14 days after first Day 0 visit (in each country where the study is conducted),, until 360 H1N1 (swine) influenza cases identified or Day 385 ] [ Designated as safety issue: No ]
  • Frequency / duration of protocol specified influenza-like illness symptoms [ Time Frame: From Day 0 until 360 H1N1 (swine) influenza cases identified or Day 385; and from 14 days after first Day 0 visit (in each country where the study is conducted), until 360 H1N1 (swine) influenza cases identified or Day 385 ] [ Designated as safety issue: No ]
  • Incidence of solicited local and general signs and symptoms after vaccination in each treatment group [ Time Frame: 7-day (Day 0-6) follow-up period after vaccination ] [ Designated as safety issue: No ]
  • Incidence of all unsolicited AEs in each treatment group [ Time Frame: Days 0 - 42 ] [ Designated as safety issue: No ]
  • Counts and incidence rates of medically attended adverse events, serious adverse events, and potentially immune-mediated disorders [ Time Frame: Days 0 to 385 ] [ Designated as safety issue: No ]
  • Counts and incidence rates of clinically significant laboratory abnormalities [ Time Frame: Days 7 and 21. ] [ Designated as safety issue: No ]

Enrollment: 4066
Study Start Date: November 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
One injection of GSK2340274A vaccine
Biological: GSK2340274A
One intramuscular injection
Experimental: Group B
One injection of GSK2340273A vaccine
Biological: GSK2340273A
One intramuscular injection

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.
  • Satisfactory baseline medical assessment by history and physical examination.
  • Safety laboratory test results within the parameters specified in the protocol.
  • 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 demonstrated 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 A/California/7/2009 (H1N1)v-like virus 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 other than the study vaccines between Day 0 and the phlebotomy 21 days after vaccination.
  • Planned administration of any monovalent pandemic (H1N1)v-like vaccine other than the study vaccines during the whole study (Day 0 - Day 385).
  • Previous vaccination 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, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
  • Presence of a temperature >= 38.0ºC (>= 100.4 ºF), oral temperature assessment preferred, 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.
  • Receipt of systemic glucocorticoids within 1month 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 are eligible if no such doses are given in the 24 hours before a study vaccination. Persons receiving prophylactic antiplatelet medications, e.g., low-dose acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are eligible.
  • History of 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 vaccines 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 other than the study vaccine between Day 0 and the phlebotomy 21 days after the second study vaccine dose.
  • Use of any investigational or non-registered product within 30 days preceding the first dose of study vaccine, 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 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: NCT00979602

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00979602     History of Changes
Other Study ID Numbers: 113480
Study First Received: September 17, 2009
Last Updated: July 11, 2013
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 21, 2014