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Purified Vero Rabies Vaccine-Serum Free Compared to Human Diploid Cell Vaccine in a Pre-exposure Prophylaxis Regimen

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01930357
First received: August 22, 2013
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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.

Primary Objectives:

  • To demonstrate that VRVg is non-inferior to Imovax® Rabies in terms of proportion of subjects achieving a rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 international units (IU)/mL at D42, i.e. 14 days after the last vaccination.
  • To describe if at least 99% of subjects achieve an RVNA titer ≥ 0.5 IU/mL at D42 with a lower bound of the 95% confidence interval (CI) of at least 97%, in the VRVg group.

Secondary Objectives:

  • To assess the clinical safety of each vaccine after each vaccine injection when administered in a pre-exposure schedule.
  • To describe the immune response induced by each vaccine 14 days after the last vaccination, i.e. at D42, and 6 months after the first vaccination
  • To describe the geometric mean titer ratio between the two vaccine groups at D42, i.e. 14 days after the last vaccination.

Condition Intervention Phase
Rabies
Biological: Purified Vero Rabies Vaccine Serum Free (VRVg)
Biological: Imovax® Rabies: Human Diploid Cell Vaccine (HDCV),
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of the Purified Vero Rabies Vaccine - 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number Subjects with rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 IU/mL as measured by rapid fluorescent focus inhibition test (RFFIT) [ Time Frame: Day 42 ] [ Designated as safety issue: No ]
    Rabies virus neutralizing antibody will be measured by rapid fluorescent focus inhibition test (RFFIT)


Secondary Outcome Measures:
  • Number of Participants Reporting Solicited Injection Site Reactions, Solicited Systemic Reactions, Unsolicited Systemic Reactions, and Serious Adverse Events Occurring Throughout the Trial [ Time Frame: Day 0 up to 6 months post vaccination ] [ Designated as safety issue: No ]
    Solicited injection site reactions: pain, erythema, and swelling. Solicited systemic reactions: fever (temperature), headache, malaise, and myalgia

  • Summary Individual RVNA titer ratio (Day 42/Day 0) following vaccination with either Purified Vero Rabies Vaccine Serum Free (VRVg) or Human Diploid Cell Vaccine, Imovax® Rabies [ Time Frame: Day 0 and Day 42 ] [ Designated as safety issue: No ]
    Rabies virus neutralizing antibody will be measured by rapid fluorescent focus inhibition test (RFFIT)


Enrollment: 342
Study Start Date: September 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VRVg Group
Participants will receive receive 3 vaccinations of Purified Vero Rabies Vaccine Serum Free (VRVg)
Biological: Purified Vero Rabies Vaccine Serum Free (VRVg)
0.5 mL, Intramuscular (Day 0, Day 7 and Day 28).
Active Comparator: Imovax® Rabies Group
Participants will receive receive 3 vaccinations of Human Diploid Cell Vaccine (HDCV), Imovax® Rabies
Biological: Imovax® Rabies: Human Diploid Cell Vaccine (HDCV),
0.5 mL, Intramuscular (Day 0, Day 7 and Day 28).
Other Name: Imovax® Rabies

Detailed Description:

Participants will receive a total of three vaccinations, one each at Day 0, Day 7, and Day 28, respectively, and will be assessment for immune response to rabies vaccine before the first injection (baseline titer), at Day 42, and at Month 6.

Safety will be assessed in all participants up to 28 days after each injection. Serious adverse events and adverse events of special interest (AESIs) will be collected up to 6 months after the last injection.

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 2 to 17 years on the day of inclusion
  • 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)
  • Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures. Exclusion Criteria:
  • 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)
  • 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
  • Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks following any trial vaccination
  • Any previous vaccination against rabies (in pre- or post-exposure regimen) with either the trial vaccine or another vaccine
  • Bite by a potentially rabid animal in the previous 6 months without post-exposure prophylaxis
  • Receipt of immune globulins, blood or blood-derived products in the past 3 months
  • 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)
  • 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
  • Self-reported thrombocytopenia, contraindicating intramuscular vaccination
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
  • Current alcohol abuse or drug addiction
  • Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
  • 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
  • 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
  • History of Guillain-Barré syndrome.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01930357

Locations
Philippines
Manila, Philippines, 1000
Muntinlupa City, Philippines, 1781
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur SA
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01930357     History of Changes
Other Study ID Numbers: VRV06, U1111-1127-7340, PHRR130822-000107
Study First Received: August 22, 2013
Last Updated: March 12, 2014
Health Authority: Philippines : Food and Drug Administration
United States: Food and Drug Administration

Keywords provided by Sanofi:
Rabies
Purified Vero Rabies Vaccine - Serum Free (VRVg)
Imovax® rabies
Human Diploid Cell Vaccine

Additional relevant MeSH terms:
Rabies
Mononegavirales Infections
RNA Virus Infections
Rhabdoviridae Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 27, 2014