Phase 3
Completed N=4,656
Safety and Immunogenicity Study of GSK Biologicals' Seasonal Influenza Candidate Vaccine (GSK2321138A)
Source: ClinicalTrials.gov NCT01204671 ↗Enrolled (actual)
4,656
Serious AEs
2.1%
Results posted
Jun 2013
Primary outcomePrimary: Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease — 14.7; 15.6; 14.4; 201.1 Titer
Summary
This study is designed to assess the safety and immunogenicity of a GSK Biologicals' investigational vaccine GSK2321138A in adults 18 years old and older. This study is also designed to assess the lot-to-lot consistency of vaccine GSK2321138A. The blinding will be double blind for all groups except for the GSK2604409A Group which will be open.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease |
14.7; 15.6; 14.4; 201.1; 218.4; 213.0 | — |
| PRIMARY Number of Seroconverted Subjects Against 4 Strains of Influenza Disease |
1396; 467; 425; 1287; 398; 371 | — |
| SECONDARY Number of Seropositive Subjects Against 4 Strains of Influenza Disease |
967; 352; 291; 1738; 586; 514 | — |
| SECONDARY Number of Seroprotected Subjects Against 4 Strains of Influenza Disease |
514; 167; 139; 1651; 558; 495 | — |
| SECONDARY Increase in Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease |
13.69; 13.92; 14.88; 9.28; 7.84; 9.52 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms. |
377; 362; 357; 369; 190; 13 | — |
| SECONDARY Number of Days With Solicited Local Symptoms |
2.0; 2.0; 2.0; 2.0; 2.0; 2.0 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms |
152; 154; 171; 185; 90; 9 | — |
| SECONDARY Number of Days With Solicited General Symptoms |
2.0; 2.0; 2.0; 2.0; 2.0; 2.0 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) |
125; 120; 134; 138; 92; 11 | — |
| SECONDARY Number of Subjects With Any and Related Adverse Events With Medically-attended Events (MAEs) |
688; 216; 52; 11; 4; 5 | — |
| SECONDARY Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) |
1; 1; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects With Any and Related Serious Adverse Events (SAEs) |
28; 20; 22; 26; 1; 0 | — |
Eligibility Criteria
Inclusion Criteria
- A male or female 18 years of age or older at the time of the first vaccination
- Subjects who the investigator believes can and will comply with the requirements of the protocol.
- Written informed consent obtained from the subject.
- Healthy subjects or those with chronic well-controlled disease as established by physical examination before entering into the study.
- Female subjects of non-childbearing potential may be enrolled in the study.
- 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 urine 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 within 30 days preceding the dose of the study vaccine or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
- Administration of an influenza vaccine during the 6 months preceding entry into the study.
- Planned administration / administration of a vaccine not foreseen by the study protocol within 30 days before vaccination and up to Day 21.
- Any contra-indication to intramuscular administration of the influenza vaccines.
- History of hypersensitivity/anaphylaxis to a previous dose of influenza vaccine, history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- Any administration of a long-acting immune-modifying drug within 3 months before study start, or planned administration during the study period.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Acute disease and/or fever at the time of enrolment.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- History of Guillain-Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
- Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
- History of chronic alcohol consumption and/or drug abuse.
- Any condition which, in the opinion of the investigator, prevents the subject from participating in the study
- Pregnant or lactating female.
Data sourced from ClinicalTrials.gov (NCT01204671). 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. Informational only — not medical advice.