Study of the Purified Vero Rabies Vaccine - Serum Free in Comparison With the Reference Purified Vero Rabies Vaccine

• Conditions: Prophylactic Immunization against Rabies; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-005194-20-Outside-EU/EEA
• Lead Sponsor: Sanofi Pasteur SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-17
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 816

Inclusion Criteria

Subjects aged = 18 years
1)Aged = 18 years on the day of inclusion
2)Informed Consent Form has been signed and dated
3)Able to attend all scheduled visits and to comply with all trial procedures
4)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 to 17 years
5)Aged 10 to 17 years on the day of inclusion
6)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
7)Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures
8)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
Are the trial subjects under 18? yes
Number of subjects for this age range: 408
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 408
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

All subjects
1)Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination
2)Planned participation in another clinical trial during the present trial period
3)Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
4)Planned receipt of any vaccine during the course of the trial
5)Previous vaccination against rabies (in pre- or post-exposure regimen) with either the trial vaccine or another vaccine
6)Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
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), or Hepatitis C, or reported by the parent/guardian
9)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 Category 2 or 3 bite within the year before trial participation by a suspected rabid animal with no post-exposure treatment administered)
10)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
11)Self-reported thrombocytopenia, contraindicating intramuscular vaccination, or reported by the parent/guardian
12)Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
13)Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
14)Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
15)Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
16)Known pregnancy, or a positive urine pregnancy test
17)Currently breastfeeding a child
18)Employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members of the employees or the Investigator.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: •To demonstrate that VRVg is at least as immunogenic as the reference vaccine, Verorab vaccine, in terms of proportion of subjects with a rabies virus neutralizing antibody (RVNA) titer = 0.5 international units (IU)/mL at D14, i.e. before the fourth injection, in subjects aged 10 to 17 years and in subjects aged 18 years and over.;Secondary Objective: •To assess the clinical safety of VRVg after each injection when administered in a post-exposure vaccination schedule in each respective age group and overall<br>•To describe the immune response induced by VRVg before the fourth injection (D14) and 14 days after the last injection (D42) in each respective age group and overall;Primary end point(s): Number of subject with an RVNA titer = 0.5 IU/mL by rapid fluorescent focus inhibition test (RFFIT);Timepoint(s) of evaluation of this end point: Day 14 post-vaccination

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Information concerning the safety in terms of solicited injection site and systemic reactions, unsolicited adverse events, and serious adverse events post vaccination. <br><br>2. Seropositivity status of subjects before and following vaccination;Timepoint(s) of evaluation of this end point: 1. Day 1 up to 6 months post last vaccination<br>2. Day 0, Day 14 and Day 42 post-vaccination