Rabies MedDRA version: 20.0 Level: PT Classification code 10037742 Term: Rabies System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Rabipur
Pharmaceutical Form: Powder and solvent for solution for injection in pre-filled syringe
INN or Proposed INN: Rabies vaccine
Other descriptive name: RABIES VIRUS (INACTIVATED) STRA
Sponsors
GlaxoSmithKline Biologicals S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to participate in this study, all subjects must meet ALL of the inclusion criteria described. 1. All individuals who were randomized to Conventional Rabies and JE vaccination or to Accelerated Rabies and JE vaccination or to Conventional Rabies groups during the parent study, who received the full PrEP regimen and completed the trial following V49_23 study protocol. 2. Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. 3. Individuals who can comply with study procedures. 4. Males Or Females of non-childbearing potential Or Females of childbearing potential who are using an effective birth control method which they intend to use for at least 6 months after the booster vaccination. This criterion is applicable only for those subjects who receive a booster dose. Prior to receipt of booster vaccination during Ad hoc Clinic Visit, subjects must be evaluated to confirm that they are eligible. If subjects do not meet any of the original inclusion criteria listed above, they should not receive booster dose of rabies vaccine. 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 578 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Prior to extension study entry, each subject must not have: 1. Completed the parent study V49_23 without receiving the full 3 rabies vaccine doses following the assigned pre-exposure prophylaxis regimen. 2. History of exposure to suspected or confirmed rabid animal. 3. Receipt of rabies immunoglobulins, rabies post exposure prophylaxis following completion of V49_23 study. 4. Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study. 5. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws. 6. Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to informed consent or planning to receive them during the participation to the study. 7. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent or planning to receive them during the participation to the study. 8. Received immunoglobulins or any blood products within 180 days prior to informed consent or planning to receive them during the participation to the study. 9. Study personnel as well as their immediate family or household member. 10. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study. Prior to Scheduled Visit, each subject must not have: 1. History of exposure to suspected or confirmed rabid animal. 2. Receipt of rabies immunoglobulins, non-study rabies vaccine following completion of V49_23 study. 3. Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study. 4. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws. 5. Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to informed consent or planning to receive them during the participation to the study. 6. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent or planning to receive them during the participation to the study. 7. Received immunoglobulins or any blood products within 180 days prior to informed consent or planning to receive them during the participation to the study. 8. Study personnel as well as their immediate family or household member. 9. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study. Prior to booster vaccination, each subject eligible for booster vaccination (i.e., subjects with RVNA concentrations <0.5 IU/mL at the first visit of this extension study [Day 1, Year 3] or at the following year visits [Year 4 to Year 9]) should be in good health status and must not have none of the following: 1. Progressive, unstable or uncontrolled clinical conditions. 2. Abnormal function of the immune system resulting from: a. Clinical conditions. b. Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to the Ad hoc visit or receipt or planning to receive them during the participation to the study. c. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to the Ad hoc visit or receipt or planning to receiv
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Immunogenicity Objectives: 1. To compare the long-term (up to approx.10 years) persistence of antibody responses (i.e. time until antibody concentrations drop below 0.5 IU/mL) in subjects who received a primary series of accelerated or conventional rabies PrEP intramuscular (IM) regimen in the parent study V49_23. 2. To evaluate the antibody responses to a booster dose of Purified Chick Embryo Cell-Culture (PCEC) rabies vaccine administered to subjects with Rabies Virus Neutralizing Antibody (RVNA) concentrations < 0.5 IU/mL following a primary series of accelerated or conventional rabies PrEP IM regimen in the parent study V49_23. Safety Objective: To evaluate the safety of a booster dose of PCEC rabies vaccine following a primary series of accelerated or conventional rabies PrEP IM regimen in the parent study V49_23.;Secondary Objective: Immunogenicity Objective: To evaluate the long-term (up to approx.10 years) immunogenicity in subjects who received a primary series of accelerated or conventional rabies PrEP intramuscular (IM) regimen in the parent study V49_23.;Primary end point(s): Immunogenicity Endpoints: The primary immunogenicity endpoints will be based on the RVNA concentrations at Year 3, 4, 5, 6, 7, 8, 9 and 10 following a primary series of accelerated or conventional rabies PrEP IM regimen during the parent study V49_23, as measured by rapid fluorescent focus inhibition test (RFFIT). RFFIT assays will be performed at a delegate, qualified laboratory, as specified by GSK. Measures of immunogenicity will be summarized by the vaccination regimen received in the parent study V49_23, as follows: -Time to first RVNA concentrations < 0.5 IU/mL. - Geometric Mean Concentrations (GMCs) and Geometric Mean Ratios (GMRs) for subjects receiving the booster dose, as measured by antibody concentration at 7 days after the booster dose vs. antibody concentration before the booster dose. Percentages of subjects with RVNA concentrations = 0.5 IU/mL, as me | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Immunogenicity Endpoints: - Geometric Mean Antibody Concentrations (GMCs) at Year 3, 4, 5, 6, 7, 8, 9 and 10; - Reverse Cumulative Distribution Plots (RCDPs) at Year 3, 4, 5, 6, 7, 8, 9 and 10; - Percentages of subjects with RVNA concentrations = 0.5 IU/mL, as measured by RFFIT assay at Year 3, 4, 5, 6, 7, 8, 9 and 10.;Timepoint(s) of evaluation of this end point: Year 3, 4, 5, 6, 7, 8, 9 and 10; | — |
Countries
Austria, Germany, Switzerland
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals S.A.
Outcome results
None listed