Study of Purified Vero Rabies Vaccine Serum Free Compared With Reference Purified Vero Rabies Vaccine in Healthy Adults

Rabies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00948272
• Other study ID #: VRV01
• Secondary ID: UTN: U1111-1111-
• Status: Completed
• Phase: Phase 2
• First received: July 28, 2009
• Last updated: May 27, 2014
• Start date: July 2009
• Est. completion date: August 2011

Study information

• Verified date: May 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to generate data in human on immunogenicity and safety of Purified Vero Rabies Vaccine (VRVg) in support of the vaccine registration.

Primary Objective:

• To demonstrate that VRVg is at least as immunogenic as the reference vaccine, Verorab, in terms of seroconversion rate at Day 42 of the primary vaccination series.

Secondary Objectives:

• 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 in a subset of randomized subjects and 14 days after the last vaccination of the primary vaccination series.

Description:

All subjects will receive three vaccinations for primary series and a booster vaccination at 12 months after the first vaccination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 384
• Est. completion date: August 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria :

• Aged 18 to 60 years on the day of inclusion

• Provision of a signed Informed Consent Form

• Able to attend all scheduled visits and comply with all trial procedures

• 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)

• Entitlement to national social security

Exclusion Criteria :

• For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test

• Breast-feeding woman

• Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination

• Planned participation in another clinical trial during the present trial period

• 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

• 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

• Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator

• Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures

• Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response

• Receipt of any vaccine in the 4 weeks preceding the first trial vaccination

• Planned receipt of any vaccine in the 4 weeks following any trial vaccination

• Known human immunodeficiency virus (HIV), Hepatitis B surface (HBs) antigen, or Hepatitis C seropositivity

• Previous vaccination against rabies with any vaccine (in pre- or post-exposure regimen)

• Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular (IM) vaccination

• Subject at high risk for rabies exposure during the trial period

• Subjects deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent

• Febrile illness (temperature =38.0°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment.

• Study site employee who is involved in the protocol and may have direct access to trial related data.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Rabies

Intervention

Biological:
• Purified Vero Rabies Vaccine - Serum Free
0.5 mL, Intramuscular
• Purified inactivated rabies vaccine
0.5 mL, Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

France, 

References & Publications (1)

Pichon S, Guinet-Morlot F, Minutello M, Donazzolo Y, Rouzier R, Chassard D, Fitoussi S, Hou V. A serum-free, purified vero cell rabies vaccine is safe and as immunogenic as the reference vaccine Verorab for pre-exposure use in healthy adults: results from — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To provide information concerning the immunogenicity of Purified Vero Rabies Vaccine.		42 days post-primary series vaccination	No
Secondary	To provide information concerning the safety after Purified Vero Rabies Vaccine.		0 to 7 days post-vaccination and entire study duration	Yes

External Links

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