Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1)

NCT00971425 | Completed Phase 3 Results

• 1 other identifier: 113572
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 6

Brief Summary

The objective of the study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK2340272A.

Conditions

Influenza

Keywords

influenza infection; GSK Bio's influenza vaccine GSK2340272A

Outcome Measures

Primary Outcomes (5)

• Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain

  Titers were expressed as GMTs. The Pandemrix vaccine strain was A/Cal/7/09.

  At Day 42

• Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain

  The Pandemrix vaccine strain was A/Cal/7/09. The cut-off was a titer of 1:10 and this titer was considered as seropositivity.

  At Day 42

• Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain

  The Pandemrix vaccine strain was A/Cal/7/09. A subject seroconverted for haemagglutination inhibition (HI) antibodies was defined as a subject with either a prevaccination (Day 0) HI antibody titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a prevaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.

  At Day 42

• Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain

  Seroconversion Factor (SCF) is defined as the fold increase in serum HI antibody GMTs post-vaccination compared to prevaccination (Day 0). The Pandemrix vaccine strain was A/Cal/7/09.

  At Day 42

• Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain

  The Pandemrix vaccine strain was A/Cal/7/09. A seroprotected subject was defined as a subject with a serum HI antibody titer greater than or equal to 1:40.

  At Day 42

Secondary Outcomes (10)

• Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains

  Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12

• Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains

  At Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12

• Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains

  At Day 21, Month 6 and Month 12 for Pandemrix vaccine strain, and at Day 0/Day 63 for Fluarix vaccine strains.

• Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains

  At Day 21, Month 6 and Month 12 for Pandemrix vaccine strain, and at Day 0/Day 63 for Fluarix vaccine strains.

• Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains

  Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12

Study Arms (2)

Placebo-Pandemrix-Fluarix Group

EXPERIMENTAL

Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.

Biological: Pandemrix (GSK investigational influenza GSK2340272A vaccine); Biological: Fluarix™; Biological: Placebo

Fluarix-Pandemrix-Placebo Group

EXPERIMENTAL

Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.

Biological: Pandemrix (GSK investigational influenza GSK2340272A vaccine); Biological: Fluarix™; Biological: Placebo

Interventions

Pandemrix (GSK investigational influenza GSK2340272A vaccine) BIOLOGICAL

2 doses intramuscular injections

Fluarix-Pandemrix-Placebo Group; Placebo-Pandemrix-Fluarix Group

Fluarix™ BIOLOGICAL

1 dose intramuscular injection

Fluarix-Pandemrix-Placebo Group; Placebo-Pandemrix-Fluarix Group

Placebo BIOLOGICAL

1 dose intramuscular injection

Fluarix-Pandemrix-Placebo Group; Placebo-Pandemrix-Fluarix Group

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.

You may not qualify if:

• Previous administration of the 2009 Southern Hemisphere or 2009-2010 Northern Hemisphere 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 the GSK2340272A candidate vaccine.
• Use of any investigational or non-registered product 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 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 axillary temperature \>= 37.5°C, 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.
• 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 histological-confirmed basal cell carcinoma of the skin successfully treated with local excisions only are eligible and may be enrolled within 3 years of diagnosis, but other histological types of skin cancer require a 3-year untreated and disease-free window as above.
• Women who are disease free for 3 years or more after the treatment of breast cancer and receiving long-term prophylactic tamoxifen are eligible and may be enrolled.
• 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 and during the entire study period.
• 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 antiplatelet medications, e.g., low-dose aspirin, and without a clinically-apparent bleeding tendency, are eligible.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (6)

GSK Investigational Site

Rednitzhembach, Bavaria, 91126, Germany

Location

GSK Investigational Site

Mainz, Rhineland-Palatinate, 55116, Germany

Location

GSK Investigational Site

Freital, Saxony, 01705, Germany

Location

GSK Investigational Site

Berlin, 12157, Germany

Location

GSK Investigational Site

Hamburg, 22335, Germany

Location

GSK Investigational Site

Hamburg, 22415, Germany

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 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2009
• First Posted: September 3, 2009
• Study Start: September 8, 2009
• Primary Completion: November 16, 2009
• Study Completion: October 8, 2010
• Last Updated: August 17, 2018
• Results First Posted: March 4, 2011

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share

Locations

DE (6)