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

NCT01930357 | Completed Phase 2

• 3 other identifiers: VRV06U1111-1127-7340PHRR130822-000107
• Study Type: interventional
• Target: 342
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Rabies

Keywords

Rabies; Purified Vero Rabies Vaccine - Serum Free (VRVg); Imovax® rabies; Human Diploid Cell Vaccine

Outcome Measures

Primary Outcomes (1)

• Number Subjects with rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 IU/mL as measured by rapid fluorescent focus inhibition test (RFFIT)

  Rabies virus neutralizing antibody will be measured by rapid fluorescent focus inhibition test (RFFIT)

  Day 42

Secondary Outcomes (2)

• Number of Participants Reporting Solicited Injection Site Reactions, Solicited Systemic Reactions, Unsolicited Systemic Reactions, and Serious Adverse Events Occurring Throughout the Trial

  Day 0 up to 6 months post vaccination

• 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

  Day 0 and Day 42

Study Arms (2)

VRVg Group

EXPERIMENTAL

Participants will receive receive 3 vaccinations of Purified Vero Rabies Vaccine Serum Free (VRVg)

Biological: Purified Vero Rabies Vaccine Serum Free (VRVg)

Imovax® Rabies Group

ACTIVE COMPARATOR

Participants will receive receive 3 vaccinations of Human Diploid Cell Vaccine (HDCV), Imovax® Rabies

Biological: Imovax® Rabies: Human Diploid Cell Vaccine (HDCV),

Interventions

Purified Vero Rabies Vaccine Serum Free (VRVg) BIOLOGICAL

0.5 mL, Intramuscular (Day 0, Day 7 and Day 28).

VRVg Group

Imovax® Rabies: Human Diploid Cell Vaccine (HDCV), BIOLOGICAL

0.5 mL, Intramuscular (Day 0, Day 7 and Day 28).

Also known as: Imovax® Rabies

Imovax® Rabies Group

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (2)

Unknown Facility

City of Muntinlupa, 1781, Philippines

Location

Unknown Facility

Manila, 1000, Philippines

Location

Related Publications (1)

• Quiambao B, Montalban C, Minutello AM, Guinet-Morlot F, Moureau A, Petit C, Pichon S. Serum-free purified Vero rabies vaccine is safe and immunogenic in children: Results of a randomized phaseII pre-exposure prophylaxis regimen study. Vaccine. 2022 Aug 19;40(35):5170-5178. doi: 10.1016/j.vaccine.2022.06.061. Epub 2022 Jul 26.

  PMID: 35906106 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Rabies

Condition Hierarchy (Ancestors)

Rhabdoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Medical Director

  Sanofi Pasteur SA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2013
• First Posted: August 28, 2013
• Study Start: September 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: June 1, 2015
• Last Updated: April 25, 2017

Record last verified: 2017-04

Locations

PH (2)