Submitted by: Sarah Jane M. Patoc 2017-08-25 00:00:00 Last Updated by: Sarah Jane M. Patoc 2018-10-15 14:29:39


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 E-Mail 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 E-Mail 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

CP-PRO-QVLP-012

2017-CT0412

2017-07-07

0000-00-00

1000

1000

Unspecified

01 Oct 2017

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
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

Utilization Utilization Info
No records found.

Copyright © One Window Project 2020. All rights reserved.