Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza (H1N1 Influenza Virus) Vaccine in Adults, Using Two Different Manufacturing Processes

NCT00992511 | Completed Phase 3 Results

• 1 other identifier: 113809
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 4

Brief Summary

The objective of this study is to evaluate the immunogenicity and safety of one or two doses of GSK Biologicals' investigational influenza vaccine GSK2340272A, manufactured using two different processes, in adults aged 18 to 60 years.

Conditions

Influenza

Keywords

influenza infection; GSK Bio's influenza vaccine GSK2340272A

Outcome Measures

Primary Outcomes (2)

• Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain

  A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:10, that usually is accepted as indicating protection.

  At Day 21

• Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease

  Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.

  At Day 21

Secondary Outcomes (17)

• Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain

  At Days 0 and 42

• Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease

  At Days 0 and 42

• Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain

  At Days 182 and 364

• Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease

  At Days 182 and 364

• Number of Seroconverted (SCR) Subjects for HI Antibodies

  At Days 21 and 42

Study Arms (4)

GSK2340272A New 1D Group

EXPERIMENTAL

Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the New process-manufactured (New 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.

Biological: GSK investigational vaccine GSK2340272A

GSK2340272A New 2D Group

EXPERIMENTAL

Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the New process-manufactured (New 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.

Biological: GSK investigational vaccine GSK2340272A

GSK2340272A INI 1D Group

EXPERIMENTAL

Healthy male or female adults, between and including 18 to 60 years of age, who received one dose of the Initial process-manufactured (INI 1D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.

Biological: GSK investigational vaccine GSK2340272A

GSK2340272A INI 2D Group

EXPERIMENTAL

Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the Initial process-manufactured (INI 2D) GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.

Biological: GSK investigational vaccine GSK2340272A

Interventions

GSK investigational vaccine GSK2340272A BIOLOGICAL

One intramuscular injection of initial process-manufactured GSK2340272A vaccine

GSK2340272A New 1D Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All subjects must satisfy ALL the following criteria at study entry:
• A male or female aged 18 to 60 years of age 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, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or 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 vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

You may not qualify if:

• 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 vaccine or planned use during the study period.
• 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 (99.5°F), or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
• Clinically or virologically confirmed influenza infection within 6 months preceding the study start.
• 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 6 months of study enrolment or planned administration during the study period.
• Receipt of any immunoglobulins and/or any blood products within 3 months of study enrolment or planned administration of any of these products during the study period.
• Any significant disorder of coagulation or treatment with coumarin derivatives, other vitamin K antagonists 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.
• Any contraindication to intramuscular administration of the influenza vaccines.
• An acute evolving neurological disorder or history of Guillain-Barré syndrome.
• Administration of any vaccines within 30 days before vaccination.
• 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.
• Pregnant or lactating female
• Female planning to become pregnant or planning to discontinue contraceptive precautions.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (4)

GSK Investigational Site

Dresden, Saxony, 01067, Germany

Location

GSK Investigational Site

Dresden, Saxony, 01307, Germany

Location

GSK Investigational Site

Freiberg, Saxony, 09599, Germany

Location

GSK Investigational Site

Leipzig, Saxony, 04103, 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

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: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2009
• First Posted: October 9, 2009
• Study Start: October 14, 2009
• Primary Completion: November 9, 2010
• Study Completion: November 9, 2010
• Last Updated: January 31, 2019
• Results First Posted: January 31, 2019

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share

Locations

DE (4)