Safety Study of Pandemic Candidate Influenza Vaccines in the Elderly Population

NCT00306995 | Completed Phase 2 Results

• 1 other identifier: 102499
• Study Type: interventional
• Target: 385
• Locations: 1 country
• Sites: 10

Brief Summary

Influenza pandemics are caused by viruses that possess an Hemagglutinin molecule to which most of the population lacks immunity. If such virus is pathogenic to human and demonstrates the ability to transmit from person to person, the result is a global outbreak of disease that affects a high percentage of individuals in a short period of time and is likely to cause substantially increased mortality and morbidity in all countries of the world. Recently, purely avian influenza viruses, including the H5N1, H9N2 and H7N7 subtypes, have been directly transmitted to humans, raising concern over the possibility of a new influenza pandemic among the world's immunologically naive populations. In order to face this kind of situation, a pandemic influenza vaccine has to be developed.

Conditions

Influenza; Influenza Vaccines

Keywords

prophylaxis of pandemic influenza

Outcome Measures

Primary Outcomes (20)

• Serum Haemagglutination-inhibition (HI) Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)

  Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).

  At Day 10 post Dose 1

• Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)

  Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).

  At Day 21 post Dose 1

• Number of Seroconverted Subjects Against Influenza A Subtype H9N2

  Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer lower than (\<) 1:10 and a post-vaccination titre higher than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in post-vaccination titer

  At Day 10 post Dose 1

• Number of Seroconverted Subjects Against Influenza A Subtype H9N2

  Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer \< 1:10 and a post-vaccination titre ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in post-vaccination titer

  At Day 21 post Dose 1

• Seroconversion Factor for Influenza A Subtype H9N2

  Seroconversion factor was defined as the fold increase in serum HI GMTs on day 10 compared to day 0.

  At Day 10 post Dose 1

• Seroconversion Factor for Influenza A Subtype H9N2

  Seroconversion factor was defined as the fold increase in serum HI GMTs on day 21 compared to day 0.

  At Day 21 post Dose 1

• Number of Seroprotected Subjects Against H9N2

  Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection.

  At Day 10 post Dose 1

• Number of Seroprotected Subjects Against H9N2

  Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection.

  At Day 21 post Dose 1

• Number of Subjects With Seroprotection Power Against H9N2

  Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer \< 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40.

  At Day 10 post Dose 1

• Number of Subjects With Seroprotection Power Against H9N2

  Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer \< 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40.

  At Day 21 post Dose 1

• Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)

  Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).

  At Day 21 post Dose 2 (Day 42)

• Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)

  Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).

  At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)

• Number of Seroconverted Subjects Against Influenza A Subtype H9N2

  Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer \< 1:10 and a post-vaccination titre ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in postvaccination titer

  At Day 21 post Dose 2 (Day 42)

• Number of Seroconverted Subjects Against Influenza A Subtype H9N2

  Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer \< 1:10 and a post-vaccination titre ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in post-vaccination titer

  At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)

• Seroconversion Factor for Influenza A Subtype H9N2

  Seroconversion factor defined as the fold increase in serum HI GMTs on day 21 post Dose 3 (Day 42) compared to day 0.

  At Day 21 post Dose 2 (Day 42)

• Seroconversion Factor for Influenza A Subtype H9N2

  Seroconversion factor was defined as the fold increase in serum HI GMTs on day 21 post Dose 3 (Day 210 for Subset 1 and Day 386 for Subset 2) compared to day 0.

  At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)

• Number of Seroprotected Subjects Against H9N2

  Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection.

  At Day 21 post Dose 2 (Day 42)

• Number of Seroprotected Subjects Against H9N2

  Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection.

  At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)

• Number of Subjects With Seroprotection Power Against H9N2

  Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer \< 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40.

  At Day 21 post Dose 2 (Day 42)

• Number of Subjects With Seroprotection Power Against H9N2

  Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer \< 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40.

  At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)

Secondary Outcomes (19)

• Number of Subjects With Unsolicited Adverse Events (AEs)

  During the 30-days (Day 0-30) post vaccination

• Number of Subjects With Serious Adverse Events (SAEs)

  From Day 0 to Day 51

• Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells

  At Days 0, 10, 21 and 42 post vaccination

• Frequency of Antigen-specific CD4 T-cells

  At Days 0, 10, 21 and 42 post-vaccination

• Cytokine-positive CD4 T-cells Frequency

  At Days 10, 21 and 42 post-vaccination

Study Arms (7)

SB218352_15 Group

EXPERIMENTAL

Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21.

Biological: SB218352_15

SB218352_8 Group

EXPERIMENTAL

Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21.

Biological: SB218352_8

SB218352_4 Group

EXPERIMENTAL

Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21.

Biological: SB218352_4

SB218352_2 Group

EXPERIMENTAL

Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21.

Biological: SB218352_2

SB218352_8AL Group

EXPERIMENTAL

Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21.

Biological: SB218352_8AL

SB218352_4AL Group

EXPERIMENTAL

Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21.

Biological: SB218352_4AL

SB218352_2AL Group

EXPERIMENTAL

Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21.

Biological: SB218352_2AL

Interventions

SB218352_15 BIOLOGICAL

Non-adjuvanted pandemic influenza A formulation 1 vaccine

SB218352_15 Group

SB218352_8 BIOLOGICAL

Non-adjuvanted pandemic influenza A formulation 2 vaccine

SB218352_8 Group

SB218352_4 BIOLOGICAL

Non-adjuvanted pandemic influenza A formulation 3 vaccine

SB218352_4 Group

SB218352_2 BIOLOGICAL

Non-adjuvanted pandemic influenza A formulation 4 vaccine

SB218352_2 Group

SB218352_8AL BIOLOGICAL

Pandemic influenza A formulation 2 aluminium-adjuvanted vaccine

SB218352_8AL Group

SB218352_4AL BIOLOGICAL

Pandemic influenza A formulation 3 aluminium-adjuvanted vaccine

SB218352_4AL Group

SB218352_2AL BIOLOGICAL

Pandemic influenza A formulation 4 aluminium-adjuvanted vaccine

SB218352_2AL Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol
• A male or female aged over 60 years at the time of vaccination.
• Written informed consent obtained from the subject.

You may not qualify if:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
• Participation in an earlier study with a candidate pandemic H9N2 vaccine.
• Acute disease at the time of enrolment.
• Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Drug and/or alcohol dependency.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (10)

GSK Investigational Site

Finsterwalde, Brandenburg, 03238, Germany

Location

GSK Investigational Site

Ketzin, Brandenburg, 14669, Germany

Location

GSK Investigational Site

Tostedt, Lower Saxony, 21255, Germany

Location

GSK Investigational Site

Dresden, Saxony, 01219, Germany

Location

GSK Investigational Site

Dresden, Saxony, 01307, Germany

Location

GSK Investigational Site

Geringswalde, Saxony, 09326, Germany

Location

GSK Investigational Site

Schmiedeberg, Saxony, 01762, Germany

Location

GSK Investigational Site

Bad Bramstedt, Schleswig-Holstein, 24576, Germany

Location

GSK Investigational Site

Bad Segeberg, Schleswig-Holstein, 23795, Germany

Location

GSK Investigational Site

Elmshorn, Schleswig-Holstein, 25335, Germany

Location

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

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

GSKClinicalSupportHD@gsk.com

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: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2006
• First Posted: March 27, 2006
• Study Start: May 11, 2005
• Primary Completion: July 4, 2006
• Study Completion: July 4, 2006
• Last Updated: February 10, 2020
• Results First Posted: February 10, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share

Locations

DE (10)