Try our beta test site

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00989612
First received: October 1, 2009
Last updated: March 22, 2017
Last verified: March 2017
  Purpose
This trial will assess the immunogenicity and safety elicited by the adjuvanted GSK Biologicals' influenza investigational vaccine GSK2340274A in healthy Japanese adults aged 20-64 years.

Condition Intervention Phase
Influenza
Biological: Influenza investigational vaccine GSK2340274A
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety Study of GSK Biologicals' Influenza Candidate Vaccine GSK2340274A

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Titers for serum Hemagglutination Inhibition (HI) antibodies against A/California/7/2009 (H1N1)v-like antigen [ Time Frame: At Day 0 ]
    Titers are presented as geometric mean titers (GMTs).

  • Titers for serum Hemagglutination Inhibition (HI) antibodies against A/California/7/2009 (H1N1)v-like antigen [ Time Frame: At Day 21 ]
    Titers are presented as geometric mean titers (GMTs).

  • Titers for serum Hemagglutination Inhibition (HI) antibodies against A/California/7/2009 (H1N1)v-like antigen [ Time Frame: At Day 42 ]
    Titers are presented as geometric mean titers (GMTs).

  • Number of seropositive subjects for Haemagglutination Inhibition (HI) antibodies A/California/7/2009 (H1N1)v-like antigen [ Time Frame: At Day 0 ]
    A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10.

  • Number of seropositive subjects for Haemagglutination Inhibition (HI) antibodies against A/California/7/2009 (H1N1)v-like antigen [ Time Frame: At Day 21 ]
    A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10.

  • Number of seropositive subjects for Haemagglutination Inhibition (HI) antibodies against A/California/7/2009 (H1N1)v-like antigen [ Time Frame: At Day 42 ]
    A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10.

  • Number of seroconverted subjects for Haemagglutination Inhibition (HI) antibodies against A/California/7/2009 (H1N1)v-like antigen [ Time Frame: At Day 21 ]
    A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer smaller than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.

  • Number of seroconverted subjects for Haemagglutination Inhibition (HI) antibodies against A/California/7/2009 (H1N1)v-like antigen [ Time Frame: At Day 42 ]
    A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer smaller than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.

  • Number of seroprotected subjects against A/California/7/2009 (H1N1)v-like antigen [ Time Frame: At Day 0 ]
    A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.

  • Number of seroprotected subjects against A/California/7/2009 (H1N1)v-like antigen [ Time Frame: At Day 21 ]
    A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.

  • Number of seroprotected subjects against A/California/7/2009 (H1N1)v-like antigen [ Time Frame: At Day 42 ]
    A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.

  • Seroconversion factor for Hemagglutination Inhibition (HI) antibodies against A/California/7/2009 (H1N1)v-like antigen [ Time Frame: At Day 21 ]
    The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0.

  • Seroconversion factor for Hemagglutination Inhibition (HI) antibodies against A/California/7/2009 (H1N1)v-like antigen [ Time Frame: At Day 42 ]
    The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0.


Secondary Outcome Measures:
  • Number of seropositive subjects for Haemagglutination Inhibition (HI) antibodies A/California/7/2009 (H1N1)v-like antigen [ Time Frame: At Day 0 (PRE), 21, 42 and 182 ]
    A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10.

  • Titers for serum Hemagglutination Inhibition (HI) antibodies against A/California/7/2009 (H1N1)v-like antigen [ Time Frame: At Day 0 (PRE), 21, 42 and 182 ]
    Titers are presented as geometric mean titers (GMTs).

  • Number of seroconverted subjects for Haemagglutination Inhibition (HI) antibodies against A/California/7/2009 (H1N1)v-like antigen [ Time Frame: At Days 21, 42 and 182 ]
    A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer smaller than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.

  • Number of seroprotected subjects against A/California/7/2009 (H1N1)v-like antigen [ Time Frame: At Day 0 (PRE), 21, 42 and 182 ]
    A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.

  • Seroconversion factor for Hemagglutination Inhibition (HI) antibodies against A/California/7/2009 (H1N1)v-like antigen [ Time Frame: At Day 21, 42 and 182 ]
    The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0.

  • Titers for serum neutralizing antibodies against A/California/7/2009 (H1N1)v-like antigen [ Time Frame: At Day 0 (PRE), 21, 42 and 182 ]
    Titers are presented as geometric mean titers (GMTs).

  • Number of seropositive subjects for neutralizing antibodies A/California/7/2009 (H1N1)v-like antigen [ Time Frame: At Day 0 (PRE), 21, 42 and 182 ]
    A seropositive subject was defined as a subject whose serum antibody titer was greater than or equal to (≥) 1:10.

  • Number of seroconverted subjects for neutralizing antibodies against A/California/7/2009 (H1N1)v-like antigen [ Time Frame: At Day 0 (PRE), 21, 42 and 182 ]
    A seroprotected subject was defined as a vaccinated subject with a minimum 4-fold increase in post vaccination neutralizing titer.

  • Number of subjects with any and Grade 3 solicited local symptoms [ Time Frame: During a 7-day (Day 0-6) follow-up after each vaccination ]
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.

  • Number of subjects with any, Grade 3 and related solicited general symptoms [ Time Frame: During a 7-day (Day 0-6) follow-up after each vaccination ]
    Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

  • Number of subjects with any, Grade 3 and related unsolicited adverse events (AEs) [ Time Frame: During a 21-day (Day 0-20) follow-up period after the first vaccination and during a 63-day (Day 21-84) follow-up after the second vaccination ]
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

  • Number of subjects with serious adverse events (SAEs) [ Time Frame: During the entire study period (Day 0-182) ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  • Number of subjects with any adverse events of specific interest (AESIs). [ Time Frame: During the entire study period (Day 0-182) ]
    An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.

  • Number of days with any solicited local symptoms [ Time Frame: During a 7-day (Day 0-6) follow-up after each vaccination ]
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade .

  • Number of days with any solicited general symptoms [ Time Frame: During a 7-day (Day 0-6) follow-up after each vaccination ]
    Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.


Enrollment: 100
Study Start Date: October 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GSK2340274A GROUP
Healthy subjects, aged 20 to 64 years, male and female, received 2 doses of GSK2340274A vaccine, injected intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Biological: Influenza investigational vaccine GSK2340274A
Two intramuscular injections on Day 0 and Day 21, respectively

Detailed Description:
This Protocol Posting has been updated following Protocol amendment 1& 2, October 2009. The sections impacted are study design and outcome measures
  Eligibility

Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Japanese male and female adults 20 to 64 years of age at time of the first vaccination, inclusive.
  • Good general health as assessed by medical history and physical examination
  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the subject.
  • 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 other multiple-user device.
  • Females of non-childbearing potential may be enrolled in the study.
  • Female of childbearing potential may be enrolled in the study, if she:
  • 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.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • History of previous administration of a novel [H1N1]v vaccine.
  • Previous participation in study NCT00742885.
  • Presence of significant acute or chronic, uncontrolled medical or psychiatric illness.
  • Presence or 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.
  • 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 warfarin derivatives or heparin.
  • An acute evolving neurological disorder or history of Guillain-Barré syndrome.
  • Administration of any vaccines within 30 days before vaccination or planned administration within the first vaccination up to blood sampling at Day 42 and within 30 days prior to blood sampling at Day 182, with the exception of seasonal influenza vaccine.
  • Administration of any seasonal influenza vaccine within 14 days before vaccination on Day 0, or planned administration within the first vaccination up to blood sampling at Day 42 and within 14 days prior to blood sampling at Day 182.
  • Any known or suspected allergy to any constituent of influenza vaccines or component used in the manufacturing process of the study vaccine; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
  • Known pregnancy or a positive urine test result prior to the time of first vaccination.
  • Lactating or nursing female.
  • Excessive underweight (Body Mass Index [BMI] < 18.5) or excessive obesity (BMI >= 30).
  • Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.
  • Clinically or virologically confirmed influenza infection within 6 months preceding the study start.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00989612

Locations
Japan
GSK Investigational Site
Fukuoka, Japan, 813-8588
GSK Investigational Site
Tokyo, Japan, 204-8585
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 113519
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 113519
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 113519
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 113519
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 113519
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 113519
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 113519
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00989612     History of Changes
Other Study ID Numbers: 113519
Study First Received: October 1, 2009
Last Updated: March 22, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
influenza infection
GSK Biologicals' influenza vaccine GSK2340272A

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 29, 2017