Phase 3
Completed N=43,695
Trial to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine GSK2186877A in Adults 65 Year of Age and Older
Source: ClinicalTrials.gov NCT00753272 ↗Enrolled (actual)
43,695
Serious AEs
18.6%
Results posted
Jun 2012
Primary outcomePrimary: Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection. — 274; 310 Participants
Summary
The purpose of this study is to evaluate the efficacy of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in adults 65 year of age and older. The study design is divided in two surveillance phases: one passive phase along the study during the influenza season and one active surveillance phase during the influenza peak season.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection. |
262; 296 | — |
| PRIMARY Serum Hemagglutination-inhibition (HI) Antibody Titers, Against Each of the 3 Vaccine Influenza Strains, in the FluNG Groups. |
15.9; 15.8; 15.8; 82.3; 83.6; 93.4 | — |
| SECONDARY Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection. |
262; 296 | — |
| SECONDARY Number of Subjects Reporting Culture-confirmed Influenza A and/or B Infection. |
144; 145 | — |
| SECONDARY Number of Subjects Reporting Pneumonia or Clinical Influenza After the First Dose of Vaccine. |
202; 225 | — |
| SECONDARY Number of Subjects Reporting All-cause Death After the First Dose of Vaccine. |
63; 88 | — |
| SECONDARY Number of Subjects Reporting Hospitalization Due to Respiratory Diseases After the First Dose of Vaccine |
84; 89 | — |
| SECONDARY Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID). |
103; 99; 22; 14; 13; 7 | — |
| SECONDARY Number of Subjects Reporting Any and Related to Vaccination Serious Adverse Events (SAEs). |
4071; 4066; 9; 6 | — |
| SECONDARY Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms. |
40; 18; 0; 0; 1225; 477 | — |
| SECONDARY Number of Days With Any Grade of Solicited Local Symptoms |
3.6; 4.0; 2.5; 2.1; 2.9; 2.5 | — |
| SECONDARY Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms |
39; 31; 1; 0; 998; 440 | — |
| SECONDARY Number of Days With Any Grade of Solicited Local Symptoms. |
2.8; 3.6; 2.5; 2.0; 2.8; 2.6 | — |
| SECONDARY Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Symptoms |
391; 239; 11; 5; 285; 163 | — |
| SECONDARY Number of Days With Any Grade of Solicited General Symptoms |
2.8; 2.9; 2.5; 2.7; 2.2; 2.2 | — |
| SECONDARY Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms. |
258; 176; 10; 4; 169; 90 | — |
| SECONDARY Number of Days With Any Grade of Solicited General Symptoms. |
2.7; 3.0; 2.6; 2.7; 2.3; 2.6 | — |
| SECONDARY Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs). |
320; 306; 36; 26; 42; 20 | — |
| SECONDARY Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit |
1018; 996; 223; 211; 16; 7 | — |
| SECONDARY Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit. |
849; 864; 158; 154; 7; 5 | — |
| SECONDARY Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains. |
23.4; 25.0; 80.0; 75.0; 28.5; 27.3 | — |
| SECONDARY Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains |
23.9; 24.3; 76.9; 70.5; 57.8; 46.5 | — |
| SECONDARY Number of Seroconverted Subjects for HI Antibodies Against Each of the 3 Vaccine Influenza Strains |
307; 298; 310; 471; 461; 455 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- A man or woman aged 65 years or older at the time of the vaccination.
- Written informed consent obtained from the subject.
- Subjects with residence status allowing free mixing with general community.
Exclusion Criteria
- Bedridden subjects
- Previous vaccination against influenza since February 2008.
- Previous vaccination in the last three years with an investigational adjuvanted candidate seasonal or pandemic influenza vaccine.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Any contra-indication to intramuscular administration of the influenza vaccines.
- History of hypersensitivity to a previous dose of influenza vaccine.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine including egg and chicken protein.
- 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. Oral temperature <37.5°C (99.5°F).
Data sourced from ClinicalTrials.gov (NCT00753272). 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.