Study of the Purified Vero Rabies Vaccine - Serum Free in Comparison With the Reference Purified Vero Rabies Vaccine
Immunogenicity and Safety of the Purified Vero Rabies Vaccine - Serum Free in Comparison With the Reference Purified Vero Rabies Vaccine in Post-exposure Use in Healthy Subjects in China
2 other identifiers
interventional
816
1 country
1
Brief Summary
This study is designed to gather safety and immunogenicity data with Purified Vero Rabies Vaccine - Serum Free (VRVg), when given in a post-exposure prophylaxis vaccination schedule, using the Essen regimen, across different populations. Primary Objective:
- To demonstrate that VRVg is at least as immunogenic as the reference vaccine, Verorab vaccine, in terms of proportion of participants with a rabies virus neutralizing antibody titer ≥ 0.5 IU/mL at Day 14, i.e., before the fourth vaccination, in participants aged 10 to 17 years and in participants aged 18 years and over. Secondary Objectives:
- To assess the clinical safety of VRVg after each vaccination when administered in a post-exposure prophylaxis vaccination schedule in each respective age group and overall
- To describe the immune response induced by VRVg before the fourth vaccination and 14 days after the last vaccination in each respective age groups and overall.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 19, 2011
CompletedFirst Posted
Study publicly available on registry
April 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedMay 28, 2014
May 1, 2014
11 months
April 19, 2011
May 27, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Information on the rabies virus neutralizing antibody (RVNA) titer post vaccination
Rabies virus neutralizing antibody (RVNA) titer as determined by rapid fluorescent focus inhibition test (RFFIT)
Day 14
Secondary Outcomes (1)
Information concerning the safety in terms of solicited injection site and systemic reactions, unsolicited adverse events, and serious adverse events post vaccination.
Day 1 up to 6 months post last vaccination
Study Arms (4)
VRVg Vaccine Group 1
EXPERIMENTALParticipants aged 18 years or older will receive Purified Vero Rabies Vaccine Serum Free (VRVg)
VRVg Vaccine Group 2
EXPERIMENTALParticipants aged 10 to 17 years will receive Purified Vero Rabies Vaccine Serum Free (VRVg)
Verorab Vaccine Group 1
ACTIVE COMPARATORParticipants aged 18 years or older will receive Verorab Vaccine
Verorab Vaccine Group 2
ACTIVE COMPARATORParticipants aged 10 to 17 years will receive Verorab Vaccine
Interventions
0.5 mL, Intramuscular
0.5 mL, Intramuscular
Eligibility Criteria
You may qualify if:
- Adults (≥ 18 years)
- Informed consent form has been signed and dated
- Able to attend all scheduled visits and to comply with all trial procedures
- For a woman of childbearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination
- Subjects aged 10-17 years:
- Informed consent form has been signed and dated by the parent(s) or another legally acceptable representative and by subjects aged 12 years and over. In addition, provision of assent form signed by subjects aged 10 to 11 years
- Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures
- For a female of childbearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to the first vaccination, until at least 4 weeks after the last vaccination.
You may not qualify if:
- Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination
- Planned participation in another clinical trial during the present trial period
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
- Planned receipt of any vaccine during the course of the trial
- Previous vaccination against rabies (in pre- or post-exposure regimen) with either the trial vaccine or another vaccine
- Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
- 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)
- Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C, or reported by the parent/guardian
- At high risk for rabies infection during the trial: (such as veterinarians and their staff, animal handlers, rabies researchers, and certain laboratory workers, persons whose activities bring them into frequent contact with rabies virus or potentially rabid bats, raccoons, skunks, cats, dogs, or other species at risk for having rabies, people travelling where rabies is enzootic, previous bite by a rabid animal with no post-exposure treatment administered)
- Known systemic hypersensitivity to any of the vaccine components , or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
- Self-reported thrombocytopenia, contraindicating intramuscular vaccination, or reported by the parent/guardian
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
- Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
- Known pregnancy, or a positive urine pregnancy test
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Nanning, Guangxi, 530028, China
Related Publications (1)
Li R, Huang L, Li J, Mo Z, He B, Wang Y, Wu X, Minutello M, Guinet-Morlot F, Pichon S. A next-generation, serum-free, highly purified Vero cell rabies vaccine is safe and as immunogenic as the reference vaccine Verorab(R) when administered according to a post-exposure regimen in healthy children and adults in China. Vaccine. 2013 Dec 5;31(50):5940-7. doi: 10.1016/j.vaccine.2013.10.043. Epub 2013 Oct 19.
PMID: 24148575RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Sanofi Pasteur SA
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2011
First Posted
April 20, 2011
Study Start
April 1, 2011
Primary Completion
March 1, 2012
Study Completion
September 1, 2012
Last Updated
May 28, 2014
Record last verified: 2014-05