Phase 3
Completed N=119
A Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix/Influsplit SSW 2012/2013 in People Aged 18 Years and Above
Source: ClinicalTrials.gov NCT01607112 ↗Enrolled (actual)
119
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcomePrimary: Humoral Immune Response in Terms of Haemagglutination (HA) Antibody Titers Against Each of the Three Vaccine Influenza Strains — 20.57; 19.02; 366.04; 110.44 Titer
Summary
The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' trivalent influenza vaccine manufactured for the 2012/2013 influenza season administered in adults (18 to 60 years) and in elderly (over 60 years).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Humoral Immune Response in Terms of Haemagglutination (HA) Antibody Titers Against Each of the Three Vaccine Influenza Strains |
20.57; 19.02; 366.04; 110.44; 16.17; 23.90 | — |
| PRIMARY Number of Subjects Who Were Seroprotected for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. |
9; 5; 24; 23; 12; 11 | — |
| PRIMARY Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. |
45; 34; 34; 14; 38; 24 | — |
| PRIMARY Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains. |
4.2; 8.2; 2.4; 3.2; 2.7; 3.8 | — |
| PRIMARY Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the Three Vaccine Influenza Strains Above the Cut-off Value. |
35; 33; 36; 18; 17; 7 | — |
| SECONDARY Humoral Immune Response in Terms of Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. |
22.13; 16.18; 92.92; 132.89; 24.02; 23.76 | — |
| SECONDARY Number of Subjects Who Were Seroprotected for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. |
9; 5; 24; 23; 12; 11 | — |
| SECONDARY Number of Subjects Who Seroconverted for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. |
15; 19; 6; 8; 11; 13 | — |
| SECONDARY Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains. |
4.2; 8.2; 2.4; 3.2; 2.7; 3.8 | — |
| SECONDARY Duration of Solicited Local Symptoms. |
2.5; 2.0; 2.0; 2.0; 2.5; 2.0 | — |
| SECONDARY Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. |
0; 0; 0; 0; 2; 4 | — |
| SECONDARY Duration of Solicited General Symptoms. |
2.5; 3.0; 1.0; 2.0; 1.0; 1.0 | — |
| SECONDARY Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. |
2; 4; 0; 0; 2; 1 | — |
| SECONDARY Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). |
8; 11; 0; 1; 4; 3 | — |
| SECONDARY Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) |
0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who the investigator believes can and will comply with the requirements of the protocol.
- A male or female aged 18 years or above at the time of vaccination.
- Written informed consent obtained from the subject.
- Healthy subjects or subjects with well-controlled chronic diseases as established by medical history and clinical examination before entering 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 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 vaccination.
Exclusion Criteria
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within the six months prior to vaccination. Inhaled and topical steroids are allowed.
- Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned administration during the study period.
- Administration of an influenza vaccine within the six months preceding the study vaccination.
- Planned administration/ administration of a vaccine other than the study vaccine within 30 days before study vaccination and during the entire study period.
- Clinically or virologically confirmed influenza infection within the six months preceding the study vaccination.
- Acute disease and/or fever at the time of enrolment.
- Acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Chronic underlying disease, not stabilized or clinically serious.
- History of chronic alcohol consumption and/or drug abuse.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of Guillain-Barré syndrome.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Anaphylaxis following the administration of vaccine(s).
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
- Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
Data sourced from ClinicalTrials.gov (NCT01607112). 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.