Phase 2
Completed N=2,007
Immunogenicity and Safety Study to Evaluate Different Formulations of GSK Biologicals' Influenza Vaccine GSK576389A
Source: ClinicalTrials.gov NCT00540592 ↗Enrolled (actual)
2,007
Serious AEs
5.6%
Results posted
May 2012
Primary outcomePrimary: Haemagglutination Inhibition (HI) Antibody Titers — 82.3; 102.2; 98.2; 91.7 titer
Summary
In order to find the formulation leading to a maximal increase of the immune response while maintaining an acceptable safety profile, this study is designed to evaluate the immunogenicity, safety and reactogenicity of the different formulations of GSK Biologicals' influenza vaccine administered in adults aged 65 years and older compared to Fluarix.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Haemagglutination Inhibition (HI) Antibody Titers |
82.3; 102.2; 98.2; 91.7; 113.2; 114.4 | — |
| SECONDARY HI Antibody Titers at Day 0 and Day 21 |
10.6; 10.8; 10.1; 10.6; 12.0; 9.9 | — |
| SECONDARY HI Antibody Titers at Day 180 |
30.6; 35.1; 36.3; 32.5; 40.4; 33.7 | — |
| SECONDARY The Number of Subjects Seroconverted to HI Antibodies at Day 21 |
133; 138; 154; 130; 142; 151 | — |
| SECONDARY The Number of Subjects Seroconverted to HI Antibodies at Day 180 |
64; 73; 74; 68; 60; 77 | — |
| SECONDARY HI Antibody Seroconversion Factors at Day 21 |
7.7; 9.4; 9.8; 8.6; 9.4; 11.6 | — |
| SECONDARY HI Antibody Seroconversion Factors at Day 180 |
2.9; 3.3; 3.5; 3.0; 3.3; 3.5 | — |
| SECONDARY The Number of Subjects Seroprotected to HI Antibodies at Day 0 and 21 |
27; 31; 25; 33; 44; 23 | — |
| SECONDARY The Number of Subjects Seroprotected to HI Antibodies at Day 180 |
94; 111; 105; 105; 103; 104 | — |
| SECONDARY The Geometric Mean (GM) Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Days 0 and 21 |
177.48; 283.18; 204.49; 200.21; 193.35; 177.44 | — |
| SECONDARY The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Day 180 |
393.50; 348.12; 666.01; 394.45; 432.70; 421.08 | — |
| SECONDARY The GM Number of Influenza-specific CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Days 0 and 21 |
8.10; 12.90; 14.46; 3.25; 3.31; 2.31 | — |
| SECONDARY The GM Number of Influenza-specific CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Day 180 |
2.57; 14.64; 3.61; 4.75; 3.05; 1.24 | — |
| SECONDARY Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) |
3; 1; 5; 1; 2; 2 | — |
| SECONDARY Duration of Solicited Local AEs |
5.0; 6.0; 6.0; 2.0; 2.5; 3.0 | — |
| SECONDARY Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs |
15; 23; 36; 16; 21; 45 | — |
| SECONDARY Duration of Solicited General AEs |
3.0; 2.0; 2.0; 2.0; 2.0; 2.0 | — |
| SECONDARY Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs |
41; 32; 51; 39; 34; 42 | — |
| SECONDARY Number of Subjects Reporting Any, Grade 3 and Related Adverse Events Resulting in Medically Attended Visit Between Day 0 and Day 20 |
15; 10; 19; 15; 16; 14 | — |
| SECONDARY Number of Subjects Reporting Any, Grade 3 and Related Adverse Events Resulting in Medically Attended Visit Between Day 21 and Day 179 |
78; 60; 79; 71; 65; 67 | — |
| SECONDARY Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 0 and Day 20 |
0; 3; 2; 2; 2; 4 | — |
| SECONDARY Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 21 and Day 179 |
18; 9; 5; 8; 9; 10 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female aged 18-40 years old or 65 years or older at the time of the vaccination.
- Written informed consent obtained from the subject.
- Free of an acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed examination) before entering into the study.
- If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
Exclusion Criteria
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to vaccination, or planned use during the study period.
- 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 during the entire study period.
- Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
- Vaccination against influenza since January 2007 (with 2007/2008 or 2006/2007 influenza vaccine).
- Administration of more than 14 days of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- Hypersensitivity to a previous dose of influenza vaccine.
- Allergy to any component of the vaccine.
- Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.
- Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. axillary temperature<37.5ºC (99.5ºF).
- Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the study vaccine or planned administration during the study.
- Any medical conditions in which IM injections are contraindicated.
- Lactating female or female planning to become pregnant or to discontinue contraceptive precautions
Data sourced from ClinicalTrials.gov (NCT00540592). 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.