A Randomized, Observer-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy, Safety, and Immunogenicity of a Plant-Derived Quadrivalent VLP Influenza Vaccine in Adults 18-64 Years of Age
PHRR170830-001664
CP-PRO-QVLP-012
2017-CT0412
A Randomized, Observer-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy, Safety, and Immunogenicity of a Plant-Derived Quadrivalent VLP Influenza Vaccine in Adults 18-64 Years of Age
This Phase 3 study is intended to assess the efficacy of the Quadrivalent VLP Influenza Vaccine during the 2017-2018 influenza season in healthy adults 18 to 64 years of age. One dose of Quadrivalent VLP Influenza Vaccine (30 μg/strain) or
of placebo will be administered to approximately 10,000 subjects.
| Start Date | Duration in Months | Target Completion Date | Actual Completion Date |
|---|---|---|---|
| 2017-10-01 | 10 | 2018-08-01 | 0000-00-00 |
Completed
| Institution | Classification | Region | LTO # |
|---|---|---|---|
| Medicago R&D Inc. | Private Business | Canada | None |
| Institution | Region |
|---|---|
| Medicago R&D Inc. | Canada |
| Name | Institution and Institution Address | |
|---|---|---|
| Sarah Jane Patoc | sarah.patoc@iconplc.com | 24th Floor, Salcedo Towers 169 H.V. Dela Costa St. Salcedo Village, Makati City Philippines 1227" |
| Name | Institution and Institution Address | |
|---|---|---|
| Dr. Anthony Japour, MD | Anthony.Japour@iconplc.com | 2100 Pennbrook Parkway North Wales, PA United States, 19454 |
| Name | Expertise | Affiliation |
|---|---|---|
| Camilo C. Roa Jr., MD | Internal Medicine | San Juan De Dios Educational Foundation, Inc., |
| Grace Devota G. Go, MD | Pediatrics | Mary Chiles General Hospital |
| Mari Rose A. Delos Reyes, MD | Infectious Diseases | Research Institute for Tropical Medicine |
| Remigio Olveda, MD | Infectious Diseases | Research Institute for Tropical Medicine |
| Ronald Allan R. Payumo, MD | Pulmonolgy | Mary Johnston Hospital |
| Socorro Lupisan, MD | Infectious Diseases | Research Institute for Tropical Medicine |
| Project Location | Institutional Ethics Review Board |
|---|---|
| San Juan De Dios Educational Foundation, Inc., | N/A |
| Mary Chiles General Hospital | Mary Chiles General Hospital Ethics Review Committee |
| Research Institute for Tropical Medicine | Research Institute for Tropical Medicine Institutional Review Board |
| Research Institute for Tropical Medicine | Research Institute for Tropical Medicine Institutional Review Board |
| Mary Johnston Hospital | Mary Johnston Hospital Ethics & Review Committee |
| Research Institute for Tropical Medicine | Research Institute for Tropical Medicine Institutional Review Board |
Influenza
To evaluate the efficacy, relative to placebo, of a single dose of the Quadrivalent VLP Influenza Vaccine given at a dose of 30 μg/strain, against laboratory-confirmed influenza caused by vaccine-matched strains.
Unspecified
Completed
- Denmark
- Finland
- Philippines
- Thailand
- United Kingdom
- United States
Clinical Trial
2017-CT0412
2017-07-07
0000-00-00
1000
1000
Unspecified
2017-10-01
Inclusion Criteria
1. Subjects must be able to read, understand, and sign the informed consent form (ICF);
complete study-related procedures; and communicate with the study staff at visits and by
phone;
2. Subject must have a body mass index (BMI) below 40 kg/m2;
3. Subjects are considered by the Investigator to be reliable and likely to cooperate with the
assessment procedures and be available for the duration of the study;
4. Male and female subjects must be 18 to 64 (has not yet had his/her 65th birthday) years of
age, inclusive, at the Screening/Vaccination visit (Visit 1);
Exclusion Criteria
Exclusion Criteria
1. Any subject whose medical condition(s) is sufficiently severe that annual influenza
vaccination would be routinely recommended in the jurisdiction of recruitment;
2. According to the Investigator’s opinion, history of significant acute or chronic, uncontrolled
medical or neuropsychiatric illness. ‘Uncontrolled’ is defined as:
• Requiring a new medical or surgical treatment during the three months prior to study
vaccine administration unless the criteria outlined in inclusion criterion no. 5 can be met
(i.e. the Investigator can justify inclusion based upon the innocuous nature of
medical/surgical events and/or treatments);
3. Any medical or neuropsychiatric condition or any history of excessive alcohol use or drug
abuse which, in the Investigator’s opinion, would render the subject unable to provide
informed consent or unable to provide valid safety observations and reporting;
Interventional
Quadrivalent VLP Influenza Vaccine
Quadrivalent VLP Influenza Vaccine given at a dose of 30 μg/strain
None
Randomized
Double Blind
Unspecified
Parallel
To evaluate the efficacy, relative to placebo, of a single dose of the Quadrivalent VLP Influenza Vaccine given at a dose of 30 μg/strain, against laboratory-confirmed influenza caused by vaccine-matched strains.
Phase III