Purified Vero Rabies Vaccine–Serum Free Compared to Human Diploid Cell
Vaccine in a Pre-exposure Prophylaxis Regimen
Last Updated on: 2015-07-02 15:09:15
Registry ID: PHRR130822-000107
Secondary Identification Number: Protocol No. VRV06; 2013-CT0096
UNIQUE URL
http://registry.healthresearch.ph//index.php?option=com_healthregistry&controller=registry&task=researchde
tails&id=452
SCIENTIFIC TITLE
Immunogenicity and Safety of the Purified Vero Rabies Vaccine ጀ Serum Free (VRVg) in Comparison with
the Human Diploid Cell Vaccine, Imovax® Rabies in a Pre-exposure Prophylaxis Regimen in Healthy
Children and Adolescents Aged 2 to 17 Years
PROJECT DESCRIPTION
The aim of the study is to document immunogenicity and safety of VRVg in a pre-exposure regimen in
healthy children and adolescents aged 2 to 17 years.
PROJECT DURATION
Start Date
Duration in Months
Target Completion Date
Actual Completion Date
2013-09-03
16
2015-01-03
0000-00-00
PROJECT STATUS
Completed
IMPLEMENTING AGENCY (PRIMARY SPONSOR)
Name of Institution
Classification
Region
Sanofi Pasteur
Private Business
NCR
LTO #
COOPERATING AGENCY (SECONDARY SPONSOR)
None
FUNDING AGENCY (SOURCES OF MONETARY OR MATERIAL SUPPORT)
Contact #s.: (+632) 8377534, (+632) 8377537, (+632) 8372071-80 loc. 2117, 2112
Email: [email protected]
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1. Sanofi Pasteur
CONTACT FOR PUBLIC QUERIES
Name:
Erah
Jean
Baria
Email Address:
[email protected]
Phone Number:
Postal Address:
+6324799106
4F Feliza Bldg, 108
V.A Rufino St.,
Legaspi Village
Makati City
CONTACT FOR SCIENTIFIC QUERIES
Name:
Email Address:
Phone Number:
Postal Address:
Thelma
Laot
[email protected]
+6324799106
4F Feliza Bldg, 108 V.A
Rufino St., Legaspi
Village Makati City
INVESTIGATING TEAM
Name
Expertise
Affiliation
Beatriz P. Quiambao, MD
Pediatric and Infectious Disease
Specialist
Research Institute for Tropical
Medicine
Ma. Cecilia Montalban, MD
Infectious Disease Specialist
Manila Doctors Hospital
HEALTH CONDITION(S) OR PROBLEM(S) STUDIED
Rabies
PRIMARY OUTCOMES
Number Subjects with rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 IU/mL as measured by rapid
fluorescent focus inhibition test (RFFIT)
KEY SECONDARY OUTCOMES
Number of Participants Reporting Solicited Injection Site Reactions, Solicited Systemic
Reactions, Unsolicited Systemic Reactions, and Serious Adverse Events Occurring Throughout
the Trial
DATE OF FIRST ENROLLMENT
2013-09-03
Contact #s.: (+632) 8377534, (+632) 8377537, (+632) 8372071-80 loc. 2117, 2112
Email: [email protected]
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RECRUITMENT STATUS
Completed
COUNTRIES OF RECRUITMENT
Philippines
RESEARCH CLASSIFICATION
Clinical Trial
PROJECT LOCATION & INSTITUTIONAL ETHICS REVIEW BOARD WHICH APPROVED THE STUDY
Project Location
Institutional Ethics Review Board
Research Institute for Tropical Medicine
Research Institute for Tropical Medicine Institutional Review
Board
Manila Doctors Hospital
Manila Doctors Hospital Institutional Review Board
FDA DOCUMENT TRACKING NUMBER
Unspecified
FDA / ERC APPROVAL DATE
2013-06-21
AMENDMENT APPROVAL DATES/REASONS
None
KEY INCLUSION AND EXCLUSION CRITERIA (CT)
Inclusion Criteria: 1. Aged 2 to 17 years on the day of inclusion 2. Informed consent form has been signed
and dated by the parent(s) (and subject, if applicable by local regulations), or another legally acceptable
representative and by an independent witness, as applicable, and the assent form has been signed and
dated by the subject (if applicable by the local Ethics Committee or country regulations) 3. Subject and
parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial
procedures. Exclusion Criteria: 1. Subject is pregnant, or lactating, or of childbearing potential (to be
considered of non-childbearing potential, a female must be pre-menarche, surgically sterile, or using an
effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until
at least 4 weeks after the last vaccination) 2. Participation at the time of study enrollment (or in the 4 weeks
preceding the first trial vaccination) or planned participation during the present trial period in another clinical
trial investigating a vaccine, drug, medical device, or medical procedure 3. Receipt of any vaccine in the 4
Contact #s.: (+632) 8377534, (+632) 8377537, (+632) 8372071-80 loc. 2117, 2112
Email: [email protected]
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weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks following any trial
vaccination 4. Any previous vaccination against rabies (in pre- or post-exposure regimen) with either the trial
vaccine or another vaccine 5. Bite by a potentially rabid animal in the previous 6 months without postexposure prophylaxis 6. Receipt of immune globulins, blood or blood-derived products in the past 3 months
7. Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy,
such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term
systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past
3 months) 8. Self-reported seropositivity for Human Immunodeficiency Virus (HIV) 9. Known systemic
hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine
containing any of the same substances 10. Self-reported thrombocytopenia, contraindicating intramuscular
vaccination 11. Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
contraindicating intramuscular vaccination 12. Deprived of freedom by an administrative or court order, or in
an emergency setting, or hospitalized involuntarily 13. Current alcohol abuse or drug addiction 14. Chronic
illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or
completion 15. Moderate or severe acute illness/infection (according to investigator judgment) on the day of
vaccination or febrile illness (temperature ≥ 38.0°C). A prospective subject should not be included in the
study until the condition has resolved or the febrile event has subsided 16. Identified as an Investigator or
employee of the Investigator or study center with direct involvement in the proposed study, or identified as
an immediate family member (i.e., spouse, natural or adopted child) of the Investigator or employee with
direct involvement in the proposed study 17. History of Guillain-Barré syndrome.
STUDY TYPE
Interventional
INTERVENTION NAME
Purified Vero Rabies Vaccine Serum Free (VRVg) and Imovax® Rabies: Human Diploid Cell Vaccine
(HDCV),
INTERVENTION DESCRIPTION
Participants will either receive VRVg 0.5mL Intramuscular (IM)or HDCV 0.5mL IM on Day 0 Day 7 and Day
28
METHOD OF ALLOCATION
Randomized
MASKING / BLINDING
Single Blind
MASKING DETAILS
Contact #s.: (+632) 8377534, (+632) 8377537, (+632) 8372071-80 loc. 2117, 2112
Email: [email protected]
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None
ASSIGNMENT
Parallel
PURPOSE
Prevention. This is to document immunogenicity and safety of VRVg in a pre-exposure regimen in healthy
children and adolescents aged 2 to 17 years.
PHASE
Phase II
TARGET SAMPLE SIZE (PHILIPPINES)
342
ACTUAL SAMPLE SIZE (PHILIPPINES)
0
REASON FOR THE DIFFERENCE BETWEEN TARGET & ACTUAL SAMPLE SIZES
NA
DATE OF FIRST ENROLLMENT
2013-09-03
RESEARCH UTILIZATION
None
Contact #s.: (+632) 8377534, (+632) 8377537, (+632) 8372071-80 loc. 2117, 2112
Email: [email protected]
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