Safety and Immune Response of One-Dose of Candidate H1N1 Influenza Vaccine GSK2340274A in Adults

This study has been withdrawn prior to enrollment.
(Study was cancelled before enrolment for reasons not related to vaccine safety or efficacy.)
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01008956
First received: November 5, 2009
Last updated: February 24, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Influenza
Biological: GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340274A
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine GSK2340274A in Adults 18 to 64 Years of Age

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Humoral immune response in terms of Hemagglutination Inhibition (HI) antibodies (Vaccine virus-homologous responses) [ Time Frame: At Day 21 after vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Humoral immune response in terms of HI antibodies against A/California/7/2009 (H1N1)v-like antigen and any drifted strains [ Time Frame: At Day 0, 21 and 182 after vaccination ] [ Designated as safety issue: No ]
  • Humoral immune response in terms of neutralizing antibodies against A/California/7/2009 (H1N1)v-like antigen and any drifted strains [ Time Frame: At Day 0, 21 and 182 after vaccination ] [ Designated as safety issue: No ]
  • Occurrence of solicited local and general symptoms [ Time Frame: During a 7-day (Day 0-6) follow-up period after vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events [ Time Frame: During a 21-day (Day 0-20) follow-up period after vaccination and from Days 0 to 84. ] [ Designated as safety issue: No ]
  • Occurrence of medically attended and/or serious adverse events, and of potentially immune-mediated diseases. [ Time Frame: From the beginning up to the end of the study (Day 182) ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2010
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Group
Subjects enrolled in this group will be stratified by age (18 to 40 years and 41 to 64 years)
Biological: GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340274A
Intramuscular injection, one dose

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  • 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.
  • 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).
  • 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 10 mg/day of prednisone or equivalent when administered for > 2 weeks. Topical, intra-articular or 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 aspirin, 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 vaccines within 30 days before vaccination. Seasonal influenza vaccine may be administered up to 14 days prior to study vaccination.
  • Planned administration of any vaccine not foreseen by the study protocol from vaccination up to blood sampling at Day 21 including seasonal influenza vaccine or a monovalent pandemic H1N1 vaccine other than the study vaccine.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the receipt of study vaccine, or planned use during the study period.
  • Any known or suspected allergy to any constituent of influenza vaccines or component used in the manufacturing process of the study vaccine; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
  • Known pregnancy or a positive urine beta-human chorionic gonadotropin (ß-hCG) test result prior to the time of vaccination.
  • Lactating or nursing female.
  • Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01008956

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01008956     History of Changes
Other Study ID Numbers: 113924
Study First Received: November 5, 2009
Last Updated: February 24, 2011
Health Authority: India: Drugs Controller General of India

Keywords provided by GlaxoSmithKline:
Pandemic
GSK Bio's influenza vaccine GSK2340274A
Influenza
H1N1

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014