Phase 3
N=5,071
Study to Evaluate the Safety and Immunogenicity of a Pandemic Influenza Vaccine in Adults Aged 18 Years and Above
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT00319098 ↗Enrolled (actual)
5,071
Serious AEs
1.1%
Results posted
Aug 2017
Primary outcome: Primary: Number of Subjects With Solicited Local Symptoms — 212; 16; 39; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Adjuvanted pandemic influenza candidate vaccine (Biological); Fluarix (Biological); Placebo (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jan 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Solicited Local Symptoms |
212; 16; 39; 3; 8; 1 | — |
| PRIMARY Number of Subjects With Solicited General Symptoms (Dose 1) |
625; 57; 100; 13; 47; 1 | — |
| PRIMARY Number of Subjects With Solicited General Symptoms (Dose 2) |
513; 47; 41; 6; 46; 3 | — |
| PRIMARY Number of Subjects With Solicited General Symptoms (Across Doses) |
874; 82; 130; 15; 87; 4 | — |
| PRIMARY Number of Subjects With Unsolicited Adverse Events (AEs) |
917; 74; 244; 19; 95; 5 | — |
| PRIMARY Number of Subjects With AEs |
644; 75; 180; 23; 65; 9 | — |
| PRIMARY Number of Subjects With Serious Adverse Events (SAEs) |
27; 15; 10; 5 | — |
| PRIMARY Number of Subjects With New Onset Chronic Diseases (NOCDs) |
9; 7; 3; 0 | — |
| PRIMARY Number of Subjects With Medically Significant Conditions (MSCs) |
60; 10; 11; 3 | — |
| SECONDARY Anti- Haemagglutinin Antibody (Anti-HA) Titers Against Avian Influenza A Subtype H5N1 |
5.0; 5.0; 5.0; 5.0; 31.8; 43.8 | — |
| SECONDARY Number of Seroconverted Subjects Against H5N1 |
147; 89; 5; 5; 245; 128 | — |
| SECONDARY Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam Influenza Strain |
6.4; 8.8; 1.2; 1.5; 61.4; 37.4 | — |
| SECONDARY Number of Seroprotected Subjects Against A/Vietnam Influenza Strain |
0; 0; 0; 0; 147; 89 | — |
Summary
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00319098). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.