Rabies (Healthy Volunteers)
Conditions
Keywords
Rabies Vaccine
Brief summary
Primary Objective: To describe the immune response induced by VRVg-2 and Verorab vaccine at Day 14 (to assess the immune response after 3 doses \[2-2-2\]) and Day 42 (to assess the immune response after 4 doses \[2-2-2-0-2\]) when administered as standalone in healthy pediatric population or co-administered with HRIG (Group 5 and Group 6) at Day 0 in healthy adults. Secondary Objectives: * To describe the immune response induced by VRVg-2 and Verorab vaccine at Day 14 (to assess the immune response after 3 doses \[2-2-2\]) when co-administered with ERIG (Group 3 and Group 4) at Day 0 in healthy adults * To describe the immune response induced by VRVg-2 and Verorab vaccine at D90 (to assess the immune response 90 days post-rabies simulated exposure) when administered as standalone in healthy pediatric population or co-administered with HRIG (Group 5 and Group 6) at Day 0 in healthy adults * To describe the safety profile of VRVg-2 and Verorab vaccine as standalone in pediatric population or when co-administered with ERIG (Group 3 and Group 4) or HRIG (Group 5 and Group 6) at Day 0 in adults, after each vaccination.
Detailed description
The duration of each participant's participation in the study is approximately 7 months (28 day-vaccination period followed by 6 month safety follow-up period).
Interventions
BIOLOGICALPurified vero rabies vaccine - serum free VRVg-2
Pharmaceutical form:freeze-dried Route of administration: intradermal
BIOLOGICALPurified inactivated rabies vaccine
Pharmaceutical form:freeze-dried Route of administration: intradermal
BIOLOGICALEquine rabies immunoglobulins (ERIG) (only Group 3 and Group 4)
Pharmaceutical form: liquid/solution in 5 mL vials Route of administration: intramuscular
BIOLOGICALHuman rabies immunoglobulins (HRIG) (only Group 5 and Group 6)
Pharmaceutical form: liquid/solution in 2 mL vials Route of administration: intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Modified double-blind: the participant (or legally acceptable representative) and the Investigator remain unaware of the treatment assignments throughout the study. An unblinded qualified trial staff member will prepare and administer the appropriate vaccine but will not be involved in the immunogenicity and safety evaluations.
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Inclusion criteria : * Aged ≥ 1 year on the day of inclusion * Participant (adult ≥ 18 years without upper age limit) or participant and participant's parent/LAR (child ≥ 1 to \< 18 years) are able to attend all scheduled visits and to comply with all study procedures The following criterion only applies to healthy adults ≥ 18 years: \- Body Mass Index (BMI): 18.5 kg/m2 ≤ BMI ≤ 30 kg/m2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants in Group 1, Group 2, Group 5 and Group 6 achieving rabies virus neutralizing antibody (RVNA) titer greater than or equal to (≥) 0.5 IU/mL | Day 14 (post-vaccination) | RVNA titers will be measured by rapid fluorescent focus inhibition test (RFFIT) |
| Percentage of participants in Group 1, Group 2, Group 5 and Group 6 achieving RVNA titer greater than or equal to (≥) 0.5 IU/mL | Day 42 (post-vaccination) | RVNA titers will be measured by RFFIT |
| Number of Participants in Group 1, Group 2, Group 5 and Group 6 achieving RVNA titer greater than or equal to (≥) lower limit of quantification | Day 14 (post-vaccination) | RVNA titers will be measured by RFFIT Lower limit of quantification for RFFIT assay is 0.2 IU/mL |
| Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination) in Group 1, Group 2, Group 5 and Group 6 Participants | Day 14 (post-vaccination) | RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 14 RVNA ratios Day14/Day0 will be calculated |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants reporting unsolicited systemic AEs | Between each vaccination and up to 28 days after the last vaccination | Unsolicited (spontaneously reported) systemic AEs |
| Number of participants reporting serious adverse events (SAEs) | Up to 6 months post-vaccination | SAEs, including adverse event of special interest (AESIs) |
| Percentage of participants in Group 3 and Group 4 achieving rabies virus neutralizing antibody (RVNA) titer greater than or equal to (≥) 0.5 IU/mL | Day 14 (post-vaccination) | RVNA titers will be measured by RFFIT |
| Number of Participants in Group 3 and Group 4 achieving RVNA titer greater than or equal to (≥) lower limit of quantification | Day 14 (post-vaccination) | RVNA titers will be measured by RFFIT Lower limit of quantification for RFFIT assay is 0.2 IU/mL |
| Number of participants reporting immediate adverse events (AEs) | Within 30 minutes post-vaccination | Includes unsolicited (spontaneously reported) systemic AEs |
| Percentage of participants in Group 1, Group 2, Group 5 and Group 6 achieving rabies virus neutralizing antibody (RVNA) titer greater than or equal to (≥) 0.5 IU/mL | Day 90 (post-vaccination) | RVNA titers will be measured by RFFIT |
| Number of Participants in Group 1, Group 2, Group 5 and Group 6 achieving RVNA titer greater than or equal to (≥) lower limit of quantification | Day 90 (post-vaccination) | RVNA titers will be measured by RFFIT Lower limit of quantification for RFFIT assay is 0.2 IU/mL |
| Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination) in Group 1, Group 2, Group 5 and Group 6 Participants | Day 90 (post-vaccination) | RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 90 RVNA ratios Day90/Day0 will be calculated |
| Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination) in Group 3 and Group 4 Participants | Day 14 (post-vaccination) | RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 14 RVNA ratios Day14/Day0 will be calculated |
| Percentage of participants reporting solicited injection site reactions | Within 7 days post-vaccination | Solicited injection site reactions: * tenderness, erythema, swelling in toddlers (aged ≥ 1 year to \< 2 years) * pain, erythema, and swelling in children (aged 2 years to \< 12 years), in adolescents and adults (aged ≥ 12 years) |
| Percentage of participants reporting solicited systemic reactions | Between Day 0 and Day 3, between Day 3 and Day 7, and during the 7 days following the remaining vaccinations | Solicited systemic reactions: * fever, vomiting, crying abnormal, drowsiness, appetite lost, irritability in toddlers (aged ≥ 1 year to \< 2 years) * fever, headache, malaise and myalgia in children (aged 2 years to \< 12 years), adolescents or adults (aged ≥ 12 years) |
| Number of participants reporting unsolicited injection site AEs | Within 28 days post-vaccination | Unsolicited (spontaneously reported) injection site AEs |
Countries
Thailand
Outcome results
None listed