Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02218697 | Evaluation of the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine Influsplit™ Tetra (Fluarix™ Tetra) (GSK2321138A) When Co-administered With Pneumovax™ 23 in Adults 50 Years of Age and Older | PHASE3 | COMPLETED | 357 | — | — | Oct 1, 2014 | May 4, 2015 | Apr 3, 2018 | 6 | Belgium, France |
HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios (Control Group/Co-Ad Group). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), FluA/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/2/2012 (Yamagata).
Anti-pneumococcal antibody concentrations were expressed as adjusted geometric mean concentrations (GMCs) and adjusted GMC ratio (Control Group/Co-Ad Group).
| Arm | Type | Description |
|---|---|---|
| Co-Ad Group | EXPERIMENTAL | Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28. |
| Control Group | EXPERIMENTAL | Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28. |
| Name | Type | Description |
|---|---|---|
| Influsplit™ Tetra (Fluarix™ Tetra) | BIOLOGICAL | Intramuscular injection, 1 dose each in Control and Co-Ad groups. |
| Pneumovax™ 23 | BIOLOGICAL | Intramuscular injection, 1 dose each in Control and Co-Ad groups. |
| Placebo (Saline) | BIOLOGICAL | Intramuscular injection, 1 dose each in Control and Co-Ad groups. |
Inclusion Criteria: * Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits). * A male or female aged 50 years or above at the time of the first vaccination at risk for complicatio...