Immunogenicity and Safety of Vaccine GSK2340272A (H1N1) and GSK Biologicals Fluarix™ Vaccine When Co-administered in Elderly

NCT00968890 | Completed Phase 2 Results

• 1 other identifier: 113525
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of the present study is to assess the immunogenicity, safety and reactogenicity of a two-dose schedule with vaccine GSK2340272A when co-administered with GSK Biologicals' Fluarix™ vaccine either at the time of first or second vaccination in elderly subjects aged 61 years and older.

Conditions

Influenza

Keywords

GSK Bio's influenza vaccine GSK2340272A; Influenza infection

Outcome Measures

Primary Outcomes (3)

• Number of Seroconverted Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix

  A seroconverted subject is a subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer \< 10 and a postvaccination reciprocal titer \>= 40, or a pre-vaccination reciprocal HI titer \>= 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.

  21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)

• Number of Seroprotected Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix

  A seroprotected subject was a subject with reciprocal HI titers \>= 40 against the vaccine homologous virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.

  21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)

• Geometric Mean Fold Rise (GMFR) After the Second Dose of Pandemrix and After Vaccination With Fluarix

  The GMFR is defined as the Geometric Mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.

  21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)

Secondary Outcomes (9)

• Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains

  Days 0, 21, 42, 182, 364

• Number of Seroconverted Subjects

  at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364

• Number of Seroprotected Subjects

  at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364

• Geometric Mean Fold Rise (GMFR)

  at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364

• Number of Subjects With Titers Equal to or Above Titer 1:10

  Days 0, 21, 42, 182, 364

Study Arms (2)

Pandemrix+Fluarix and Pandemrix+Placebo

EXPERIMENTAL

Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.

Biological: Pandemrix (Influenza vaccine GSK2340272A); Biological: Fluarix™; Biological: Placebo

Pandemrix+Placebo and Pandemrix+Fluarix

EXPERIMENTAL

Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.

Biological: Pandemrix (Influenza vaccine GSK2340272A); Biological: Fluarix™; Biological: Placebo

Interventions

Pandemrix (Influenza vaccine GSK2340272A) BIOLOGICAL

Intramuscular injection, 2 doses

Pandemrix+Fluarix and Pandemrix+Placebo; Pandemrix+Placebo and Pandemrix+Fluarix

Fluarix™ BIOLOGICAL

Intramuscular injection, 1 dose

Also known as: 2009-2010 Northern Hemisphere trivalent seasonal influenza vaccine

Pandemrix+Fluarix and Pandemrix+Placebo; Pandemrix+Placebo and Pandemrix+Fluarix

Placebo BIOLOGICAL

Intramuscular injection, 1 dose

Pandemrix+Fluarix and Pandemrix+Placebo; Pandemrix+Placebo and Pandemrix+Fluarix

Eligibility Criteria

• Age: 61 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects 61 years of age or older at the time of the first vaccination
• Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
• Written informed consent obtained from the subject.
• Satisfactory baseline medical assessment by history and physical examination.
• Access to a consistent means of telephone contact.

You may not qualify if:

• Previous administration of the 2009 Southern Hemisphere or 2009-2010 Northern Hemisphere seasonal influenza vaccine.
• Previous administration of a pandemic influenza vaccine.
• Administration of any vaccine within 30 days before first vaccination.
• Planned administration of a vaccine not foreseen by the study protocol one month (minimum 30 days) after the second vaccination with vaccine GSK2340272A.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of the study vaccines or planned use during the study period. Potential subjects in the follow-up (i.e., no treatment) phase of a prior investigational study may be enrolled if the investigator's judgment is that it will have no effect on safety, reactogenicity, or immunogenicity endpoints in this study, and that it does not violate the protocol requirements of the prior trial.
• Presence of 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 an oral temperature \>= 37.5°C, 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 including history of human immunodeficiency virus (HIV) infection.
• Chronic administration of immunosuppressants or other immune modifying drugs within six months prior to the first vaccination.
• Receipt of any immunoglobulins and/or any blood products within 3 months preceding the first vaccination or planned administration of any of these products during the entire 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 anti-platelet 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.
• Serious chronic disease as determined by medical history and physical examination.
• Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormalities, as determined by physical examination or laboratory screening tests.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Eskilstuna, SE-631 88, Sweden

Location

GSK Investigational Site

Örebro, SE-703 62, Sweden

Location

Related Publications (1)

• Peeters M, Regner S, Vaman T, Devaster JM, Rombo L. Safety and immunogenicity of an AS03-adjuvanted A(H1N1)pmd09 vaccine administered simultaneously or sequentially with a seasonal trivalent vaccine in adults 61 years or older: data from two multicentre randomised trials. Vaccine. 2012 Oct 5;30(45):6483-91. doi: 10.1016/j.vaccine.2012.07.081. Epub 2012 Aug 9.

  PMID: 22885014 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Influenza, Human

Interventions

pandemrix; fluarix

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2009
• First Posted: August 31, 2009
• Study Start: September 12, 2009
• Primary Completion: September 23, 2010
• Study Completion: September 23, 2010
• Last Updated: August 20, 2018
• Results First Posted: March 16, 2011

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

SE (2)