Phase 3
N=526
Evaluation of Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in Adults 65 Years and Older
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT00760617 ↗Enrolled (actual)
526
Serious AEs
5.3%
Results posted
Apr 2012
Primary outcome: Primary: Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) — 2; 2; 1; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- GSK Bio's influenza vaccine GSK2186877A (Biological); Fluarix (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) |
2; 2; 1; 0; 0; 0 | — |
| PRIMARY Duration of Solicited Local AEs |
6.0; 4.0; 7.0; 2.0; 2.0; 2.0 | — |
| PRIMARY Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs |
30; 6; 10; 0; 0; 0 | — |
| PRIMARY Duration of Solicited General AEs |
2.0; 1.5; 3.0; 2.0; 2.0; 2.0 | — |
| PRIMARY Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs |
49; 20; 18; 6; 1; 4 | — |
| PRIMARY Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 0 to 20 |
20; 8; 9; 4; 1; 1 | — |
| PRIMARY Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 21 to 179 |
103; 48; 33; 26; 8; 9 | — |
| PRIMARY Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Disease (AID) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 0 to Day 20 |
4; 2; 1; 0; 0; 0 | — |
| PRIMARY Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 21 to Day 179 |
19; 7; 2; 0; 0; 0 | — |
| PRIMARY Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 180 to Day 209 |
0; 3; 0; 0; 0; 0 | — |
| SECONDARY Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21 |
27.9; 22.9; 43.2; 74.6; 57.5; 164.7 | — |
| SECONDARY HI Antibody Titers at Day 180 |
34.9; 27.7; 99.5; 90.1; 69.9; 86.1 | — |
| SECONDARY The Number of Subjects Seropositive to HI Antibodies at Day 0 and 21 |
226; 125; 97; 251; 141; 108 | — |
| SECONDARY The Number of Subjects Seropositive to HI Antibodies at Day 180 |
226; 123; 102; 235; 125; 99 | — |
| SECONDARY The Number of Subjects Seroconverted to HI Antibodies at Day 21 |
77; 46; 48; 209; 97; 67 | — |
| SECONDARY The Number of Subjects Seroconverted to HI Antibodies at Day 180 |
15; 11; 31; 99; 47; 37 | — |
| SECONDARY HI Antibody Seroconversion Factor (SCF) at Day 21 |
2.7; 2.5; 3.8; 8.7; 5.9; 5.9 | — |
| SECONDARY HI Antibody SCF at Day 180 |
1.3; 1.2; 2.4; 3.4; 2.9; 3.1 | — |
| SECONDARY The Number of Subjects Seroprotected to HI Antibodies at Day 0 and Day 21 |
124; 55; 68; 222; 108; 101 | — |
| SECONDARY The Number of Subjects Seroprotected to HI Antibodies at Day 180 |
143; 65; 89; 193; 94; 87 | — |
| SECONDARY The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 |
751.28; 682.47; 1179.17; 1431.41; 972.14; 1513.30 | — |
Summary
The purpose of this study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in adults 65 year of age and older.
This protocol posting deals with objectives & outcome measures of the extension phase at year 1. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = 00540592).
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 18-41 years or ≥65 years at the time of the vaccination and who participated in the 110847 study and completed the 6 month follow-up.
- Written informed consent obtained from the subject.
- Fee of acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed examination) before entering into the study.
- Female subjects must be of non-childbearing potential.
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 an influenza vaccine other than the study vaccines or of a vaccine not foreseen in the study protocol during the entire study period.
- Vaccination against influenza since January 2008 with a seasonal influenza vaccine.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of hypersensivity to a previous dose of influenza vaccine.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine(s).
- Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation (medical history and medical history directed physical examination) or pre-existing laboratory screening tests.
- Acute disease at the time of enrolment.
- 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, female planning to become pregnant or planning to discontinue contraceptive precautions.
Data sourced from ClinicalTrials.gov (NCT00760617). 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.