Study to Evaluate the Safety and Immunogenicity of a Pandemic Influenza Vaccine in Adults Aged 18 Years and Above
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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 Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
- 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. ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Occurrence of serious adverse events [ Time Frame: During the entire study period ] [ Designated as safety issue: No ]
- Occurrence of new onset chronic diseases [ Time Frame: During the entire period in each group ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 5075 |
| Study Start Date: | May 2006 |
| Study Completion Date: | February 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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Show 39 Study Locations| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
Publications:
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00319098 History of Changes |
| Other Study ID Numbers: | 107064, 107217 |
| Study First Received: | April 26, 2006 |
| Last Updated: | June 28, 2012 |
| Health Authority: | Spain: agencia española del medicamento |
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 |
ClinicalTrials.gov processed this record on May 16, 2013