Safety and Immunogenicity of H1N1 Vaccine With Trivalent Inactivated Seasonal Influenza Vaccine in Adults

NCT ID: NCT00985673

Last Updated: 2018-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 611 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-01
• Study Completion Date: 2010-12-29

Brief 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.

Detailed Description

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

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Flulaval/placebo/unadjuvanted Arepanrix Group

subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.

Group Type: EXPERIMENTAL

GSK2340273A

Intervention Type: BIOLOGICAL

Two intramuscular injections

Seasonal trivalent influenza vaccine (TIV)

Intervention Type: BIOLOGICAL

Single intramuscular injection

Saline placebo

Intervention Type: BIOLOGICAL

Single intramuscular injection

Flulaval/placebo/Arepanrix Group

subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.

Group Type: EXPERIMENTAL

GSK2340274A

Intervention Type: BIOLOGICAL

Two intramuscular injections

Seasonal trivalent influenza vaccine (TIV)

Intervention Type: BIOLOGICAL

Single intramuscular injection

Saline placebo

Intervention Type: BIOLOGICAL

Single intramuscular injection

Flulaval/unadjuvanted Arepanrix/placebo Group

subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.

Group Type: EXPERIMENTAL

GSK2340273A

Intervention Type: BIOLOGICAL

Two intramuscular injections

Seasonal trivalent influenza vaccine (TIV)

Intervention Type: BIOLOGICAL

Single intramuscular injection

Saline placebo

Intervention Type: BIOLOGICAL

Single intramuscular injection

Flulaval/Arepanrix/placebo Group

subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.

Group Type: EXPERIMENTAL

GSK2340274A

Intervention Type: BIOLOGICAL

Two intramuscular injections

Seasonal trivalent influenza vaccine (TIV)

Intervention Type: BIOLOGICAL

Single intramuscular injection

Saline placebo

Intervention Type: BIOLOGICAL

Single intramuscular injection

Unadjuvanted Arepanrix/placebo/Flulaval Group

subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.

Group Type: EXPERIMENTAL

GSK2340273A

Intervention Type: BIOLOGICAL

Two intramuscular injections

Seasonal trivalent influenza vaccine (TIV)

Intervention Type: BIOLOGICAL

Single intramuscular injection

Saline placebo

Intervention Type: BIOLOGICAL

Single intramuscular injection

Arepanrix/placebo/Flulaval Group

subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.

Group Type: EXPERIMENTAL

GSK2340274A

Intervention Type: BIOLOGICAL

Two intramuscular injections

Seasonal trivalent influenza vaccine (TIV)

Intervention Type: BIOLOGICAL

Single intramuscular injection

Saline placebo

Intervention Type: BIOLOGICAL

Single intramuscular injection

Interventions

GSK2340274A

Two intramuscular injections

Intervention Type: BIOLOGICAL

GSK2340273A

Two intramuscular injections

Intervention Type: BIOLOGICAL

Seasonal trivalent influenza vaccine (TIV)

Single intramuscular injection

Intervention Type: BIOLOGICAL

Saline placebo

Single intramuscular injection

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Stockbridge, Georgia, United States

GSK Investigational Site

Raleigh, North Carolina, United States

GSK Investigational Site

Austin, Texas, United States

GSK Investigational Site

Fort Worth, Texas, United States

GSK Investigational Site

Halifax, Nova Scotia, Canada

GSK Investigational Site

Montreal, Quebec, Canada

GSK Investigational Site

Sherbrooke, Quebec, Canada

Countries

United States; Canada

References

Friel D, Co M, Ollinger T, Salaun B, Schuind A, Li P, Walravens K, Ennis FA, Vaughn DW. Non-neutralizing antibody responses following A(H1N1)pdm09 influenza vaccination with or without AS03 adjuvant system. Influenza Other Respir Viruses. 2021 Jan;15(1):110-120. doi: 10.1111/irv.12780. Epub 2020 Sep 5.

Reference Type: DERIVED

PMID: 32889792 (View on PubMed)

Langley JM, Frenette L, Chu L, McNeil S, Halperin S, Li P, Vaughn D. A randomized, controlled non-inferiority trial comparing A(H1N1)pmd09 vaccine antigen, with and without AS03 adjuvant system, co-administered or sequentially administered with an inactivated trivalent seasonal influenza vaccine. BMC Infect Dis. 2012 Oct 30;12:279. doi: 10.1186/1471-2334-12-279.

Reference Type: DERIVED

PMID: 23110320 (View on PubMed)

Study Documents

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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Other Identifiers

113536

Identifier Type: -

Identifier Source: org_study_id