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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Influenza
- Sponsor
- GlaxoSmithKline
- Enrollment
- 4048
- Locations
- 1
- Primary Endpoint
- Number of A/California/7/2009 (H1N1)V-like Illness (ILI) Cases
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
Collaborators: United States Department of Health and Human Services, Office of Biomedical Advanced Research and Development Authority
Investigators
Eligibility 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
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
- •Seasonal influenza vaccine may be administered up to 14 days prior to study vaccination on Day
- •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.
Outcomes
Primary Outcomes
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.
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.
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.
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.
Secondary Outcomes
- Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain(At Day 182)
- Number of A/California Influenza Related Cases(From Day 0 up to the end of ILI surveillance (Day 385))
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(During the 7-day (Days 0-6) post-vaccination period)
- Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)(Throughout the entire study period (Day 0 - Day 385))
- Number of Subjects With Any Unsolicited Adverse Events (AEs)(Within the 42-day (Days 0-41) post-vaccination period)
- Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain(At Day 182)
- Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain(At Day 182)
- Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain(At Day 182)
- Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain(At Day 42)
- Number of ILI Symptoms in All Reported ILI Cases(From Day 14 post-vaccination through the end of ILI surveillance (Day 385))
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(During the 7-day (Days 0-6) post-vaccination period)
- Seroconversion Factor (SCF) for HI Antibodies Against A/CAL/7/09 H1N1 Virus Strain(At Day 182)
- Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels(At Days 7 and 21)
- Number of Subjects With Any Medically-attended Adverse Events (MAEs)(Throughout the entire study period (Day 0 - Day 385))
- Number of Subjects With Serious Adverse Events (SAEs)(Throughout the entire study period (Day 0 - Day 385))