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Safety and Immune Response of Candidate H1N1 Influenza Vaccine GSK2340274A Following Seasonal Influenza Vaccination in Adults

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influenza

Intervention: GSK Biologicals' FluLaval® (Biological); Placebo (saline) (Biological); GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340274A (Biological); GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340273A (Biological)

Phase: Phase 1

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

This study is designed to characterize the safety and immunogenicity of a' pandemic influenza (H1N1) candidate vaccine GSK2340274A in adults 19 to 40 years who have never received influenza vaccination.

Clinical Details

Official title: A Study to Evaluate Immune Responses Following A/California/7/2009 (H1N1)V-like Virus Vaccination Given 4 Months Following Seasonal Influenza Vaccination in Adults 19 to 40 Years of Age

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome:

Number of Seroconverted Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.

Number of Seroprotected Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.

Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.

Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.

Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.

Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Titers Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.

Number of Seroconverted Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.

Number of Seroprotected Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.

Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.

Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.

Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.

Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Titers Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.

Secondary outcome:

Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.

Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.

Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Titers Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.

Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.

Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.

Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Titers Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.

Number of Influenza-specific Cluster of Differentiation 4 (CD4) T-cells Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).

Number of Subjects Reporting Any and Related Potential Immune-mediated Disease (pIMDs).

Number of Subjects Reporting Any and Related Medically Attended Adverse Events (MAEs).

Number of Subjects Reporting Unsolicited AEs.

Number of Subjects Reporting Unsolicited AEs.

Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).

Case Descriptions for Subjects Experiencing Reverse Transcription-polymerase Chain Reaction (RT-PCR) and Culture-confirmed Influenza.

Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).

Number of Subjects Reporting Any and Related Medically Attended Adverse Events (MAEs).

Number of Subjects Reporting Any and Related Potential Immune-mediated Disease (pIMDs).

Number of Subjects Reporting Solicited Local Symptoms.

Number of Subjects Reporting Solicited General Symptoms.

Number of Subjects Reporting Solicited Local Symptoms.

Number of Subjects Reporting Solicited General Symptoms.

Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.

Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.

Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.

Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.

Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.

Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.

Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.

Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.

Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.

Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.

Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.

Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.

Eligibility

Minimum age: 19 Years. Maximum age: 40 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects who the investigator believes can and will comply with the requirements of

the protocol (e. g., completion of the diary cards, return for follow-up visits).

- Written informed consent obtained from the subject.

- Male or female adults, 19-40 years of age at the time of the first vaccination.

- Body weight of at least 110 pounds (49. 9 kg).

- Safety laboratory tests results within the parameters specified by protocol.

- Satisfactory baseline medical assessment by physical examination (stable health

status with no exclusionary conditions). Stable health status is defined as the absence of a 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 enrollment.

- 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 (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 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:

- Previous vaccination with an A/California/7/2009 (H1N1)v-like virus vaccine

- A medical history of physician-confirmed infection with an A/California/7/2009

(H1N1)v-like virus.

- Prior receipt at any time of any seasonal influenza vaccine.

- Planned administration of any vaccine not foreseen by the study protocol (including

any influenza vaccine other than the study vaccine) between Days 0 and the Day 164 phlebotomy.

- Administration of any licensed vaccine within 30 days before the first study vaccine

dose.

- Use of any investigational or non-registered product (drug or vaccine) other than the

study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.

- Receipt of systemic glucocorticoids (e. g., prednisone ≥ 0. 5 mg/kg/day, or ≥ 10 mg/day

[whichever is less] for more than 14 consecutive days) within one month prior to study enrolment, or any other cytotoxic or immunosuppressive drug within six months of study enrolment. Topical, intra-articularly injected, or inhaled glucocorticoids, topical calcineurin inhibitors or imiquimod are allowed.

- Receipt of any immunoglobulins and/or any blood products within 9 months of study

enrolment or planned administration of any of these products during the study period.

- 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.

- History of anemia.

- Presence of a temperature ≥ 38. 0ºC (≥100. 4ºF), (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.

- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on

medical history and physical examination. (No laboratory testing is required.)

- 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

six weeks of receipt of any vaccine.

- Any known or suspected allergy to any constituent of influenza vaccines (including

egg proteins or mercurial preservatives); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to any vaccine.

- Known pregnancy or a positive urine beta-human chorionic gonadotropin (β-HCG) test

result prior to first vaccination.

- Lactating or nursing women.

Locations and Contacts

GSK Investigational Site, Milford, Massachusetts 01757, United States

GSK Investigational Site, Salisbury, North Carolina 28144, United States

GSK Investigational Site, Winston-Salem, North Carolina 27103, United States

Additional Information

Starting date: February 2010
Last updated: July 12, 2012

Page last updated: August 20, 2015

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