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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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4 April 2022 |
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Main ID: |
EUCTR2009-009877-85-FR |
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Date of registration:
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04/06/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Immunogenicity of the Purified Vero Rabies Vaccine – Serum Free in Comparison with the Reference Purified Vero Rabies Vaccine in Pre-exposure Use in Healthy Adults
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Scientific title:
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Immunogenicity of the Purified Vero Rabies Vaccine – Serum Free in Comparison with the Reference Purified Vero Rabies Vaccine in Pre-exposure Use in Healthy Adults |
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Date of first enrolment:
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23/06/2009 |
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Target sample size:
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384 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-009877-85 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: yes
Other trial design description: Blind observer
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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France
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1) Aged 18 to 60 years on the day of inclusion
2) Provision of a signed Informed Consent Form
3) Able to attend all scheduled visits and comply with all trial procedures
4) For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence for at least 4 weeks prior to each vaccination, until at least 4 weeks after each vaccination)
5) Entitlement to national social security
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1) For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test
2) Breast-feeding woman
3) Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
4) Planned participation in another clinical trial during the present trial period
5) Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
6) Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
7) Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
8) Current alcohol abuse or drug addiction that may interfere with the subject’s ability to comply with trial procedures
9) Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response
10) Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
11) Planned receipt of any vaccine in the 4 weeks following any trial vaccination
12) Known human immunodeficiency virus (HIV), HBs antigen, or Hepatitis C seropositivity
13) Previous vaccination against rabies with any vaccine (in pre-or post-exposure regimen)
14) Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
15) Subject at high risk for rabies exposure during the trial period
16) Subjects deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
17) Febrile illness (temperature =38.0°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment.
18) Study site employee who is involved in the protocol and may have direct access to trial-related data
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Prophylactic Immunization against Rabies
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Intervention(s)
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Trade Name: Verorab
Product Name: Purified Vero Rabies Vaccine - Serum Free (VRVg)
Product Code: 382
Pharmaceutical Form: Powder and solvent for suspension for injection
Current Sponsor code: 382
Other descriptive name: Inactivated Rabies virus, Wistar Rabies PM/WI38 1503-3M strain produced on vero cell
Concentration unit: IU international unit(s)
Concentration type: not less then
Concentration number: 2.5-
Trade Name: Verorab
Product Code: 084
Pharmaceutical Form: Powder and solvent for suspension for injection
Current Sponsor code: 084
Other descriptive name: Inactivated Rabies virus, Wistar Rabies PM/WI38 1503-3M strain produced on vero cell
Concentration unit: IU international unit(s)
Concentration type: not less then
Concentration number: 2.5-
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Primary Outcome(s)
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Main Objective: To demonstrate that VRVg (PR1) is at least as immunogenic as the reference vaccine, Verorab (PR2), in terms of seroconversion rate at D42, i.e. 14 days after the last vaccination of primary vaccination series.
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Primary end point(s): Seroconversion status at D42: rabies virus neutralizing antibody (RVNA) titer = 0.5 IU/mL by RFFIT.
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Secondary Objective: To assess the clinical safety of VRVg after each vaccination when administered in a pre-exposure vaccination schedule with a booster at 12 months after the first vaccination in all subjects.
To describe the immune response induced by VRVg 21 days after two vaccinations (D28) in a subset of 120 randomized subjects and 14 days after the last vaccination of the primary vaccination series, i.e. at D42, in all subjects.
To describe antibody persistence at 6 and 12 months after the first vaccination in all subjects.
To describe the immune response induced by VRVg 14 days after a booster vaccination administered 12 months after the first vaccination in all subjects.
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 23/06/2009
Contact:
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