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

NCT00985088 | Completed Phase 2 Results

• 1 other identifier: 113440
• Study Type: interventional
• Target: 1,343
• Locations: 2 countries
• Sites: 14

Brief Summary

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.

Conditions

Influenza

Keywords

GSK Bio's influenza vaccine GSK2340274A; influenza infection; GSK Bio's influenza vaccine GSK2340273A

Outcome Measures

Primary Outcomes (12)

• Number of Subjects Seropositive for Haemagglutination Inhibition (HI) Antibodies Against the A/California Virus Strain

  A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (≥) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and subjects older than (\>) 60 years.

  At Day 0

• Number of Subjects Seropositive for Haemagglutination Inhibition (HI) Antibodies Against the A/California Virus Strain

  A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (≥) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and subjects \> 60 years.

  At Day 21

• Number of Subjects Seropositive for (HI) Antibodies Against the A/California Virus Strain

  A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (≥) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 64 years (y) old and subjects \> 64 years.

  At Day 0

• Number of Subjects Seropositive for (HI) Antibodies Against the A/California Virus Strain

  A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (≥) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 64 years (y) old and subjects \> 64 years.

  At Day 21

• Number of Seroconverted (SCR) Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California Virus Strain

  A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥ 1:40 and at least a 4-fold increase in pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18 and 60 years of age and older (\>60y).

  At Day 21

• Number of Seroconverted (SCR) Subjects for HI Antibodies Against A/California Strain

  A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥ 1:40 and at least a 4-fold increase in pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18 and 64 years and older (\>64y).

  At Day 21

• Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Virus Strain

  A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) and results were tabulated for subjects between 18 and 60 years and older (\>60y).

  At Day 0

• Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Virus Strain

  A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The Flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18 and 60 years and older (\>60y).

  At Day 21

• Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Strain

  A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The Flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18 and 64 years and older (\>64y).

  At Day 0

• Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Strain

  A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The Flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18 and 64 years and older (\>64y).

  At Day 21

• Seroconversion Factor (SCF) for Haemagglutination Inhibition (HI) Antibodies Against A/California Virus Strain

  SCF was defined as the fold increase in serum HI geometric mean ratio (mean\[log10(POST/PRE)\]) vaccination compared to Day 21. The flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18 and 60 years of age and older (\>60y).

  At Day 21

• Seroconversion Factor (SCF) for HI Antibodies Against A/California Strain

  SCF was defined as the fold increase in serum HI geometric mean ratio (mean\[log10(POST/PRE)\]) vaccination compared to Day 21. The flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18 and 64 years of age and older (\>64y).

  At Day 21

Secondary Outcomes (34)

• Number of Subjects Seropositive for HI Antibodies Against A/California Virus Strain

  At Days 0 and 21

• Titers for HI Antibodies Against A/California Strain

  At Days 0 and 21

• Number of Seroconverted (SCR) Subjects for HI Antibodies Against A/California Virus Strain

  At Day 21

• Number of Seroprotected (SPR) Subjects Against HI Antibodies for the A/California Virus Strain

  At Days 0 and 21

• Seroconversion Factor (SCF) for HI Antibodies Against A/California Virus Strain

  At Day 21

Study Arms (8)

GSK2340274A F1_2D Group

EXPERIMENTAL

Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.

Biological: GSK2340274A

GSK2340274A F2_2D Group

EXPERIMENTAL

Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.

Biological: GSK2340274A

GSK2340274A F2_1D Group

EXPERIMENTAL

Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.

Biological: GSK2340274A; Biological: Saline placebo

GSK2340274A F1_1D Group

EXPERIMENTAL

Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.

Biological: GSK2340274A; Biological: Saline placebo

GSK2340273A F1_1D Group

EXPERIMENTAL

Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.

Biological: GSK2340273A; Biological: Saline placebo

GSK2340273A F2_2D Group

EXPERIMENTAL

Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.

Biological: GSK2340273A

GSK2340273A F2_1D Group

EXPERIMENTAL

Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.

Biological: GSK2340273A; Biological: Saline placebo

GSK2340273A F3_2D Group

EXPERIMENTAL

Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.

Biological: GSK2340273A

Interventions

GSK2340274A BIOLOGICAL

one or two intramuscular injections

GSK2340274A F1_1D Group; GSK2340274A F1_2D Group; GSK2340274A F2_1D Group; GSK2340274A F2_2D Group

GSK2340273A BIOLOGICAL

one or two intramuscular injections

GSK2340273A F1_1D Group; GSK2340273A F2_1D Group; GSK2340273A F2_2D Group; GSK2340273A F3_2D Group

Saline placebo BIOLOGICAL

One injection

GSK2340273A F1_1D Group; GSK2340273A F2_1D Group; GSK2340274A F1_1D Group; GSK2340274A F2_1D Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (14)

GSK Investigational Site

Huntsville, Alabama, 35802, United States

Location

GSK Investigational Site

Jacksonville, Florida, 32216, United States

Location

GSK Investigational Site

Miami, Florida, 33143, United States

Location

GSK Investigational Site

Meridian, Idaho, 83642, United States

Location

GSK Investigational Site

Lenexa, Kansas, 66219, United States

Location

GSK Investigational Site

Missoula, Montana, 59801, United States

Location

GSK Investigational Site

Las Vegas, Nevada, 89104, United States

Location

GSK Investigational Site

Edison, New Jersey, 08817, United States

Location

GSK Investigational Site

Rochester, New York, 14609, United States

Location

GSK Investigational Site

Cleveland, Ohio, 44122, United States

Location

GSK Investigational Site

Surrey, British Columbia, V3R 8P8, Canada

Location

GSK Investigational Site

Truro, Nova Scotia, B2N 1L2, Canada

Location

GSK Investigational Site

Toronto, Ontario, M9W 4L6, Canada

Location

GSK Investigational Site

Pointe-Claire, Quebec, H9R 4S3, Canada

Location

Related Publications (1)

• Ferguson M, Risi G, Davis M, Sheldon E, Baron M, Li P, Madariaga M, Fries L, Godeaux O, Vaughn D. Safety and long-term humoral immune response in adults after vaccination with an H1N1 2009 pandemic influenza vaccine with or without AS03 adjuvant. J Infect Dis. 2012 Mar 1;205(5):733-44. doi: 10.1093/infdis/jir641.

  PMID: 22315336 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: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2009
• First Posted: September 28, 2009
• Study Start: October 11, 2009
• Primary Completion: November 9, 2009
• Study Completion: December 16, 2010
• Last Updated: December 12, 2017
• Results First Posted: December 12, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share

Locations

CA (4); US (10)