Immunogenicity and Safety Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine GSK2340274A in Adults 18 to 64 Years of Age

GlaxoSmithKline0 sitesApril 2010

ConditionsInfluenza

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Influenza
Sponsor: GlaxoSmithKline
Primary Endpoint: Humoral immune response in terms of Hemagglutination Inhibition (HI) antibodies (Vaccine virus-homologous responses)
Status: Withdrawn
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This study is designed to characterize the safety and immunogenicity of a' pandemic influenza (H1N1) candidate vaccine GSK2340274A in adults 18 to 64 years of age.

Registry

clinicaltrials.gov

Start Date

April 2010

End Date

October 2010

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Indian male or female adults 18 to 64 years of age at time of the first vaccination, inclusive.
•Written informed consent obtained from the subject
•Good general health as assessed by medical history and physical examination.
•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 (i.e., a common-use phone serving multiple rooms or apartments)
•Subjects who the investigator believes can and will comply with the requirements of the protocol.
•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

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.
•Presence or 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 (\>=100.4ºF) by any route or method, 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.
•Presence of significant acute or chronic, uncontrolled medical or psychiatric illness ("uncontrolled" is defined as requiring institution of new medical or surgical treatment or a significant alteration in the dose of an ongoing medication for uncontrolled symptoms, illness manifestations or drug toxicity within 3 months preceding the receipt of study vaccine).
•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 histologically-confirmed basal cell carcinoma of the skin successfully treated with local excision only are accepted and may enrol, but other histologic types of skin cancer are exclusionary.
•Women who are disease-free 3 years or more after treatment for breast cancer and receiving long-term prophylactic tamoxifen are excepted and may enrol.
•Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).

Outcomes

Primary Outcomes

Humoral immune response in terms of Hemagglutination Inhibition (HI) antibodies (Vaccine virus-homologous responses)

Time Frame: At Day 21 after vaccination

Secondary Outcomes

Occurrence of solicited local and general symptoms(During a 7-day (Day 0-6) follow-up period after vaccination.)
Humoral immune response in terms of neutralizing antibodies against A/California/7/2009 (H1N1)v-like antigen and any drifted strains(At Day 0, 21 and 182 after vaccination)
Occurrence of medically attended and/or serious adverse events, and of potentially immune-mediated diseases.(From the beginning up to the end of the study (Day 182))
Humoral immune response in terms of HI antibodies against A/California/7/2009 (H1N1)v-like antigen and any drifted strains(At Day 0, 21 and 182 after vaccination)
Occurrence of unsolicited adverse events(During a 21-day (Day 0-20) follow-up period after vaccination and from Days 0 to 84.)