Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults

NCT00951041 | Completed Phase 2 Results

• 1 other identifier: 113574
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Influenza

Keywords

influenza infection; GSK Bio's influenza vaccine GSK2340272A

Outcome Measures

Primary Outcomes (4)

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

  Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old. The primary endpoint results consist in those presented for GSK2340272A Group.

  At Day 35

• Number of Seroconverted Subjects for HI Antibodies

  Seroconversion (SCR) was defined as follows: for initially seronegative subjects, antibody titer equal to or above (≥) 1:40 after vaccination; for initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old. The primary endpoint results consist in those presented for GSK2340272A Group.

  At Day 35

• Number of Seroprotected Subjects for HI Antibodies

  A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old. The primary endpoint results consist in those presented for GSK2340272A Group.

  At Day 35

• Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease

  GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like, in subjects 18-60 years old. The primary endpoint results consist in those presented for GSK2340272A Group.

  At Day 35

Secondary Outcomes (20)

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

  At Days 0 and 21

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

  At Day 182

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

  At Day 364

• Number of Seroconverted Subjects for HI Antibodies

  At Day 21

• Number of Seroconverted Subjects for HI Antibodies

  At Day 182

Study Arms (2)

GSK2340272A Group

EXPERIMENTAL

Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.

Biological: GSK investigational vaccine GSK2340272A

GSK2340269A Group

EXPERIMENTAL

Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine. The first vaccine dose was administered intramuscularly in the deltoid region of the non-dominant arm at Day 0, and the second vaccine dose was administered intramuscularly in the deltoid region of the dominant arm at Day 21.

Biological: GSK investigational vaccine GSK2340269A

Interventions

GSK investigational vaccine GSK2340272A BIOLOGICAL

Two intramuscular injections

GSK2340272A Group

GSK investigational vaccine GSK2340269A BIOLOGICAL

Two intramuscular injections

GSK2340269A Group

Eligibility Criteria

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

You may qualify if:

• A male or female aged 18 to 60 years 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. Stable health status is defined as the absence of health event satisfying the definition of a serious adverse event, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within one month prior to enrollment.
• 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.
• Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
• 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 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, 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 the past 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 excepted and may enroll 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 3 years or more after the treatment for breast cancer and receiving long-term prophylactic are excepted and may enroll.
• Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
• Clinically or virologically confirmed influenza infection within 6 months preceding the study start.
• 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 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.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Dresden, Saxony, 01097, Germany

Location

GSK Investigational Site

Dresden, Saxony, 01099, Germany

Location

GSK Investigational Site

Dresden, Saxony, 01307, 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 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: July 31, 2009
• First Posted: August 4, 2009
• Study Start: August 11, 2009
• Primary Completion: August 30, 2010
• Study Completion: August 30, 2010
• Last Updated: November 26, 2018
• Results First Posted: November 26, 2018

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

DE (3)