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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00979602
First Posted: September 18, 2009
Last Update Posted: September 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
September 17, 2009
September 18, 2009
August 25, 2017
September 21, 2017
September 21, 2017
November 9, 2009
January 10, 2011   (Final data collection date for primary outcome measure)
  • Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain [ Time Frame: At Day 21 ]
    A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer higher than or equal to (≥)1:40 or at least a 4-fold increase of the pre-vaccination titer of ≥ 1:10. The Flu strain assessed was A/California/7/09 (H1N1)v-like (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance.
  • Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain [ Time Frame: At Day 0 ]
    A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) antibody titer ≥ 1:40 against the tested virus. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
  • Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain [ Time Frame: At Day 21 ]
    A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
  • Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain [ Time Frame: At Day 21 ]
    SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP guidance.
  • Number of A/California/7/2009 (H1N1)V-like Illness (ILI) Cases [ Time Frame: From Day 14 post-vaccination up to study end (at Day 385) ]
    The analysis focused on Quantitative Reverse Transcription Polymerase Chain Reaction Assay (RT-qPCR)-confirmed A/California/7/2009 (H1N1)v-like illness (ILI) cases.
  • Vaccine virus-homologous HI antibody response of subjects in Group A [ Time Frame: Day 0 and 21 days after the second dose ]
  • 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 second dose until 360 RT-qPCR-confirmed H1N1 (swine) influenza like illness cases or Day 385 ]
Complete list of historical versions of study NCT00979602 on ClinicalTrials.gov Archive Site
  • Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain [ Time Frame: At Days 0 and 21 ]

    Cut-off values assessed were greater than or equal to (≥) 1:10 in the sera of subjects seronegative before vaccination.

    The Flu strains assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.

  • Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain [ Time Frame: At Days 0 and 21 ]
    Titers were presented as geometric mean titers (GMTs). The flu strain assessed was /California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
  • Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain [ Time Frame: At Day 42 ]
    Cut-off values assessed were greater than or equal to (≥) 1:10 in the sera of subjects seronegative before vaccination. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
  • Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain [ Time Frame: At Day 42 ]
    Titers were presented as geometric mean titers (GMTs). The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
  • Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain [ Time Frame: At Day 182 ]
    Cut-off values assessed were greater than or equal to ≥ 1:10 in the sera of subjects seronegative before vaccination. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
  • Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain [ Time Frame: At Day 182 ]
    Titers were presented as geometric mean titers (GMTs). The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
  • Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain [ Time Frame: At Day 42 ]
    A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥1:40 and at least a 4-fold increase of the pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
  • Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain [ Time Frame: At Day 182 ]
    A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥1:40 and at least a 4-fold increase of the pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
  • Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain [ Time Frame: At Day 42 ]
    A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
  • Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain [ Time Frame: At Day 182 ]
    A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
  • Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain [ Time Frame: At Day 42 ]
    SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP.
  • Seroconversion Factor (SCF) for HI Antibodies Against A/CAL/7/09 H1N1 Virus Strain [ Time Frame: At Day 182 ]
    SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP.
  • Number of A/California Influenza Related Cases [ Time Frame: From Day 0 up to the end of ILI surveillance (Day 385) ]
    Influenza related cases included: A/California/7/2009 (H1N1)v-like influenza illness (ILI) cases, pneumonia cases, RT-qPCR confirmed influenza, culture confirmed influenza and RT-qPCR confirmed influenza with pneumonia.
  • Number of ILI Symptoms in All Reported ILI Cases [ Time Frame: From Day 0 up to the end of ILI surveillance (Day 385) ]
    Assessed ILI symptoms were fever [defined as oral temperature equal to or above (≥) 38.5 degrees Celsius (°C)], myalgia (muscle aches all over the body), cough, sore throat, runny/stuffy nose, short of breath, headache, vomiting, diarrhea, chills, fatigue.
  • Number of ILI Symptoms in All Reported ILI Cases [ Time Frame: From Day 14 post-vaccination through the end of ILI surveillance (Day 385) ]
    Assessed ILI symptoms were fever [defined as oral temperature equal to or above (≥) 38.5 degrees Celsius (°C)], myalgia (muscle aches all over the body), cough, sore throat, runny/stuffy nose, short of breath, headache, vomiting, diarrhea, chills, fatigue.
  • Number of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: During the 7-day (Days 0-6) post-vaccination period ]
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
  • Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: During the 7-day (Days 0-6) post-vaccination period ]
    Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above (≥) 38.0 degrees Celsius (°C)], headache, joint pain at other location, muscle aches, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
  • Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels [ Time Frame: At Days 7 and 21 ]
    Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], alkaline phosphatase [AP], aspartate aminotransferase [AST], basophils [BAS], total bilirubin [T/BIL], bilirubin direct [BIL/D], creatinine [CREA], eosinophils [EOS], hematocrit [HEM], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], plateles [PLA], red blood cells [RBC], blood urea nitrogen [BUN] and white blood cells [WBC. Levels of haematological/biochemical parameters assessed with respect to normal laboratory values were - unknown, below, within and above for subjects aged 18-64 years (18-64y) and >64 years old (>64y).
  • Number of Subjects With Any Medically-attended Adverse Events (MAEs) [ Time Frame: Throughout the entire study period (Day 0 - Day 385) ]
    MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
  • Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) [ Time Frame: Throughout the entire study period (Day 0 - Day 385) ]
    Potential immune-mediated diseases (pIMDs) represent a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
  • Number of Subjects With Any Unsolicited Adverse Events (AEs) [ Time Frame: Within the 42-day (Days 0-41) post-vaccination period ]
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
  • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: Throughout the entire study period (Day 0 - Day 385) ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
  • Vaccine virus- homologous and heterologous HI antibody response in Groups A and B [ Time Frame: Days 0, 42, and 182 ]
  • Vaccine virus -homologous and heterologous microneutralization antibody response in Groups A and B [ Time Frame: Days 0, 42, and 182 ]
  • 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 ]
  • 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 post second dose until 360 H1N1 (swine) influenza cases identified or Day 385 ]
  • 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 second dose, until 360 H1N1 (swine) influenza cases identified or Day 385 ]
  • 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 second dose, until 360 H1N1 (swine) influenza cases identified or Day 385 ]
  • 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 second dose, until 360 H1N1 (swine) influenza cases identified or Day 385 ]
  • 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 each vaccination ]
  • Incidence of all unsolicited AEs in each treatment group [ Time Frame: 21-day (Day 0-20) period following each vaccination vaccine (up to Day 42) ]
  • Counts and incidence rates of medically attended adverse events, serious adverse events, and potentially immune-mediated disorders [ Time Frame: Days 0 to 385 ]
  • Counts and incidence rates of clinically significant laboratory abnormalities [ Time Frame: Days 7 and 42. ]
Not Provided
Not Provided
 
Safety, Immunogenicity, and Relative Efficacy of H1N1 Vaccines in Adults Aged 18 Years and Older
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
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.
Collaborators: United States Department of Health and Human Services, Office of Biomedical Advanced Research and Development Authority
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Influenza
  • Biological: GSK2340274A
    One intramuscular injection
  • Biological: GSK2340273A
    One intramuscular injection
  • Experimental: GSK2340274A Group
    Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
    Intervention: Biological: GSK2340274A
  • Experimental: GSK2340273A Group
    Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
    Intervention: Biological: GSK2340273A
Yang WH, Dionne M, Kyle M, Aggarwal N, Li P, Madariaga M, Godeaux O, Vaughn DW. Long-term immunogenicity of an AS03-adjuvanted influenza A(H1N1)pdm09 vaccine in young and elderly adults: an observer-blind, randomized trial. Vaccine. 2013 Sep 13;31(40):4389-97. doi: 10.1016/j.vaccine.2013.07.007. Epub 2013 Jul 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4066
February 1, 2011
January 10, 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
Belgium
 
NCT00979602
113480
Not Provided
Not Provided
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
URL: http://
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP