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Study to Evaluate the Safety and Immunogenicity of a Pandemic Influenza Vaccine in Adults Aged 18 Years and Above

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00319098
First received: April 26, 2006
Last updated: November 3, 2016
Last verified: November 2016
  Purpose
Today, the leading contender for the next pandemic of influenza is H5N1, a strain of avian virus. Prevention and control will depend on the rapid production and worldwide distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be developed and tested in clinical trials to determine the most optimal formulation and the best vaccination schedule. This study is designed to test in healthy adults aged above 18 years the reactogenicity and immunogenicity of one and two administrations of a candidate pandemic H5N1 vaccine formulated from Split Virus.

Condition Intervention Phase
Influenza Biological: Adjuvanted pandemic influenza candidate vaccine Biological: Fluarix Biological: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase III, Observer-blind, Randomised Study to Evaluate the Safety and Immunogenicity of One and Two Administrations of Pandemic Monovalent (H5N1) Influenza Vaccine (Adjuvanted Split Virus Formulation) in Adults Aged 18 Years and Older

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Percentage, intensity and relationship to vaccination of solicited local and general signs and symptoms [ Time Frame: During a 7 day follow-up period after each dose of vaccine and overall. ]
  • Percentage, intensity and relationship to vaccination of unsolicited local and general signs and symptoms [ Time Frame: During a 21-day follow-up period after the first vaccination and during a 30-day follow-up period after the second vaccination ]
  • Occurrence of serious adverse events [ Time Frame: During the entire study period ]
  • Occurrence of new onset chronic diseases [ Time Frame: During the entire period in each group ]
  • Occurrence of medically significant conditions prompting emergency room visits or physician visits that are not related to common diseases or routine visits [ Time Frame: During the entire study period in each group. ]

Secondary Outcome Measures:
  • For the humoral immune response in terms of both anti-haemagglutinin (HA) antibodies and neutralising antibodies• Geometric mean titers (GMTs) of H5N1 antibody titers [ Time Frame: At days 0, 21, 42 and 180 ]
  • For the humoral immune response in terms of both anti-HA antibodies and neutralising antibodies• Seroconversion rates (SC) [ Time Frame: At days 21, 42 and 180. ]
  • For the humoral immune response in terms of both anti-HA antibodies and neutralising antibodies• Seroconversion factors [ Time Frame: At days 21, 42 and 180 ]
  • For the humoral immune response in terms of both anti-HA antibodies and neutralising antibodies• Seroprotection rates [ Time Frame: At days 0, 21, 42 and 180 ]

Enrollment: 5075
Study Start Date: May 2006
Study Completion Date: July 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Subjects in each group will be further stratified by age: 18-30 years, 31-60 years and over 60 years
Biological: Adjuvanted pandemic influenza candidate vaccine
2 doses, intramuscular injection
Active Comparator: Group B
Subjects in each group will be further stratified by age: 18-30 years, 31-60 years and over 60 years. Subjects were administered placebo for the second vaccination.
Biological: Fluarix
One intramuscular injection
Biological: Placebo
One intramuscular injection

Detailed Description:

This study has 2 phases:

The study ID 107064 corresponds to objectives & outcome measures evaluated from day 0 until day 51.

The study ID 107217 corresponds to objectives & outcome measures evaluated at day 180.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
  • A male or female aged 18 years or above at the time of the first vaccination.
  • Written informed consent obtained from the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • If the subject is female, she must be of non-childbearing potential, for 30 days prior to first vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.

Exclusion Criteria:

  • Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after the second vaccination.
  • Administration of interpandemic influenza vaccine between Day 0 and Day 51of the study. Those study participants belonging to risk groups eligible to receive the annual interpandemic influenza vaccine (in accordance with local regulations) can receive the annual vaccination after day 51 and before the end of the study on Day 180.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first administration of the study vaccine.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
  • History of chronic alcohol consumption and/or drug abuse.
  • History of hypersensitivity to vaccines.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  • Major congenital defects or serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination. (Subjects suffering from seasonal allergies or asthma under inhalative treatment can be included).
  • Acute disease at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first administration of the study vaccine or during the study.
  • Lactating women
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first vaccination, or planned use during the study period.
  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: NCT00319098

  Show 40 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 107064
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 107064
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 107064
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 107064
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: 107064
For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 107064 are summarised with study 107217 on the GSK Clinical Study Register.
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 107064
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: NCT00319098     History of Changes
Other Study ID Numbers: 107064
107217 ( Other Identifier: GSK )
Study First Received: April 26, 2006
Last Updated: November 3, 2016
Individual Participant Data (IPD) Sharing Statement:
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:
Adjuvanted pandemic influenza candidate vaccine
Influenza

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 July 27, 2017