Immunization against A/California/7/2009 (H1N1)v-like influenza in male and female subjects aged 18 to 60 years.
Conditions
Interventions
Product Name: A/California/7/2009 (H1N1)v-like vaccine (manufactured in Dresden) adjuvanted with AS03
Product Code: GSK2340272A
Pharmaceutical Form: Emulsion for injection
Other descriptive name: Inac
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • A male or female aged 18 to 60 years of age at the time of the first vaccination. • Subjects who the investigator believes that they can and will comply with the requirements of the protocol. • Written informed consent obtained from the subject. • Satisfactory baseline medical assessment by history and physical examination (stable health status with no exclusionary medical, including psychiatric conditions). Stable health status is defined as the absence of health event satisfying the definition of a serious adverse event, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within one month prior to enrolment. • 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 multiple-user device (i.e., a common-use phone serving multiple rooms or apartments). • Female subjects of non-childbearing potential may be enrolled in the study. - Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause. • 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 vaccination, and - has agreed to continue adequate contraception during the entire treatment during the entire treatment period and for 2 months after completion of the vaccination series. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period. • 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 an axillary temperature = 37.5°C (99.5°F), or acute symptoms greater than “mild” severity on the scheduled date of first vaccination. NOTE: The subject may be vaccinated at a later date, provided symptoms have resolved, vaccination occurs within the window specified by the protocol, and all other eligibility criteria continue to be satisfied. • Clinically or virologically confirmed influenza infection within 6 months preceding the study start. • Diagnosed with cancer, or treatment for cancer, within 3 years. - Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible. - Persons with a history of histological-confirmed basal cell carcinoma of the skin successfully treated with local excisions only are excepted and may enrol within 3 years of diagnosis, but other histological types of skin cancer require a 3-year untreated and disease-free window as above. - Women who are disease free 3 years or more after the treatment for breast cancer and receiving long-term prophylactic tamoxifen are excepted and may enrol. • Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection. • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune modifying drugs within 6 months of study enrolment or planned administration during the study period. For corticosteroids, this will mean a dose equivalent to >= 20 mg/day of prednisone or equivalent for persons for > 2 weeks. Inhaled and topical steroids are allowed. • Receipt of any immunoglobulins and/or any blood products within 3 months of study enrolment 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. • Administration of any vaccines within 30 days before vaccination. • Any known or suspected allergy to any constituent of influenza vaccines (including egg proteins); a history of anaphylactic-type reaction to any constituent of influenza vaccines (including egg proteins); or a history of severe adverse reaction to a previous influenza vaccine. • Pregnant or lactating female • Female planning to become pregnant or planning to discontinue contraceptive precautions. • Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the immunological equivalence (in terms of vaccine-homologous virus H1N1 HI antibody GMTs) of the Quebec-manufactured A/California/7/2009 (H1N1)v-like vaccine adjuvanted with AS03A and the Dresden-manufactured A/California/7/2009 (H1N1)v-like vaccine adjuvanted with AS03A, 21 days after the first vaccination in healthy subjects aged 18 to 60 years. Criteria for equivalence: Immunological equivalence will be demonstrated if the limits of two-sided 95% confidence interval for the GMT ratio (Flu D-PAN H1N1 vaccine over Flu Q-PAN H1N1 vaccine) in terms of HI antibody titre against A/California/7/2009 (H1N1)v-like strain are within the 0.5 - 2.0 interval. ;Secondary Objective: • To assess the immunological equivalence (in terms of vaccine-homologous virus H1N1 HI antibody GMTs) of the Quebec- and the Dresden H1N1 vaccines at Day 42 • To assess the immunological equivalence (in terms of seroconversion rate) of the Quebec- and the Dresden H1N1 vaccines at D 21. • To assess whether vaccination with the 2 H1N1 candidate vaccines results in an HI immune response to the vaccine-homologous virus that meets or exceeds the EMEA -CHMP guidance targets for pandemic vaccine at D 21 and D42. • To describe the immunogenicity to both H1N1 vaccines in terms of HI antibodies at D 21, 42, 182 and 364. • To describe the safety and reactogenicity of the 2 H1N1 vaccines in terms of solicited adverse events (AEs) 7 days after each vaccination, unsolicited AEs, 21 days post-dose 1 up to 63 days post-dose 2, AEs of specific interest (AESIs) or pIMD AEs of special interest and SAEs during the entire study period (up to Day 364).;Primary end point(s): • Humoral immune response in terms of Haemagglutination Inhibition (HI) antibodies. In all subjects from both groups against A/California/7/2009 (H1N1)v-like antigen - GMTs 21 days after first dose of vaccine (Day 21). | — |
Countries
France, Germany
Outcome results
None listed