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Safety and Immunogenicity of H1N1 Vaccine With Trivalent Inactivated Seasonal Influenza Vaccine 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 A Virus, H1N1 Subtype; Influenza Infection

Intervention: GSK2340274A (Biological); GSK2340273A (Biological); Seasonal trivalent influenza vaccine (TIV) (Biological); Saline placebo (Biological)

Phase: Phase 2

Status: Completed

Sponsored by: GlaxoSmithKline

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

Summary

The purpose of this study is to characterize the safety and immunogenicity of the H1N1 (swine) flu vaccines GSK2340274A and GSK2340273A when co-administered with the seasonal flu vaccine in adults 19 to 40 years of age.

Clinical Details

Official title: A Study to Evaluate the Safety and Immunogenicity of an A/California/7/2009 (H1N1)V-like Vaccine GSK2340274A or GSK2340273A Co-administered With Trivalent Inactivated Seasonal Influenza Vaccine in Adults 19 to 40 Years of Age.

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

Primary outcome:

Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain.

Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain.

Secondary outcome:

Number of Influenza-specific Cluster of Differentiation 4 (CD4) T-cells Per Million 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 Influenza-specific Cluster of Differentiation 8 (CD8) T-cells Per Million 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 Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed

Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed

Number of Subjects Reporting Solicited Local Symptoms.

Number of Subjects Reporting Solicited General Symptoms.

Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed

Number of Subjects Reporting Unsolicited Adverse Events (AEs).

Number of Subjects Reporting Medically Attended Visits (MAEs).

Number of Subjects Reporting Potential Immune Diseases (pIMDs).

Number of Subjects Reporting Serious Adverse Events (SAEs).

Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed

Microneutralization Antibody Titers Against A/California/7/2009 (H1N1) Strain.

Number of Subjects With a Microneutralization Titer Greater Than or Equal to 1:28 for Antibodies Against A/California/7/2009 (H1N1) Strain.

Vaccine Response Rates (VRR) for Microneutralization Antibody Titers Against A/California/7/2009 (H1N1) Strain.

Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain.

Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain.

Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain.

Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains.

Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains.

Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains.

Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains.

Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain.

Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain.

Number of Seroconverted Subjects for Antibodies Against A/ California Strain.

Number of Seroprotected Subjects for Antibodies Against A/California Strain.

Seroconversion Factor for Antibodies Against A/California Strain.

Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains.

Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains

Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains.

Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains

Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains

Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains.

Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains.

Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains.

Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains.

Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains.

Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains.

Detailed description: Collaborators: United States Department of Health and Human Services, Office of Biomedical Advanced Research and Development Authority

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.

- Written informed consent obtained from the subject.

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

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

- Satisfactory baseline medical assessment by physical examination.

- 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.

- 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

- has a negative pregnancy test on the day of first 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 H1N1v-like virus vaccine or a medical history of

physician-confirmed infection with an H1N1v-like virus.

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

- Planned administration of any vaccine not foreseen by the study protocol between Day

0 and the Day 63 phlebotomy.

- Administration of any licensed vaccine within 4 weeks before the first study vaccine

dose.

- Use of any investigational or non-registered product 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 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 three 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.

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

- 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 seasonal influenza vaccine.

- Any known or suspected allergy to any constituent of influenza vaccines; a history of

anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.

- Known pregnancy or a positive urine beta-human chorionic gonadotropin test result

prior to first vaccination.

- Lactating or nursing women.

Locations and Contacts

GSK Investigational Site, Stockbridge, Georgia 30281, United States

GSK Investigational Site, Raleigh, North Carolina 27612, United States

GSK Investigational Site, Halifax, Nova Scotia B3K 6R8, Canada

GSK Investigational Site, Montreal, Quebec H2K 4L5, Canada

GSK Investigational Site, Sherbrooke, Quebec J1H 4J6, Canada

GSK Investigational Site, Austin, Texas 78705, United States

GSK Investigational Site, Fort Worth, Texas 76135, United States

Additional Information

Related publications:

Langley J et al. Safety and immunogenicity of a monovalent H1N1 2009 vaccine with or without AS03A adjuvant when co-administered or sequentially administered with a seasonal influenza vaccine in adults 19 to 40 years of age. Abstract presented at the International Symposium on Respiratory Viral Infections - XIII (ISRVI). Rome, Italy, 13-16 March 2011.

Starting date: October 2009
Last updated: June 14, 2012

Page last updated: August 20, 2015

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