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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
403
Pharmaceutical form:freeze-dried Route of administration: intradermal
Pharmaceutical form:freeze-dried Route of administration: intradermal
Pharmaceutical form: liquid/solution in 5 mL vials Route of administration: intramuscular
Pharmaceutical form: liquid/solution in 2 mL vials Route of administration: intramuscular
Investigational Site Number :7640004
Bangkok, Thailand
Investigational Site Number :7640002
Bangkok, Thailand
Investigational Site Number :7640003
Khon Kaen, Thailand
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
RVNA titers will be measured by rapid fluorescent focus inhibition test (RFFIT)
Time frame: Day 14 (post-vaccination)
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
RVNA titers will be measured by RFFIT
Time frame: Day 42 (post-vaccination)
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
RVNA titers will be measured by RFFIT Lower limit of quantification for RFFIT assay is 0.2 IU/mL
Time frame: Day 14 (post-vaccination)
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
RVNA titers will be measured by RFFIT Lower limit of quantification for RFFIT assay is 0.2 IU/mL
Time frame: Day 42 (post-vaccination)
Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination) in Group 1, Group 2, Group 5 and Group 6 Participants
RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 14 RVNA ratios Day14/Day0 will be calculated
Time frame: Day 14 (post-vaccination)
Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination) in Group 1, Group 2, Group 5 and Group 6 Participants
RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 42 RVNA ratios Day42/Day0 will be calculated
Time frame: Day 42 (post-vaccination)
Number of participants reporting immediate adverse events (AEs)
Includes unsolicited (spontaneously reported) systemic AEs
Time frame: Within 30 minutes post-vaccination
Percentage of participants reporting solicited injection site reactions
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)
Time frame: Within 7 days post-vaccination
Percentage of participants reporting solicited systemic reactions
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)
Time frame: Between Day 0 and Day 3, between Day 3 and Day 7, and during the 7 days following the remaining vaccinations
Number of participants reporting unsolicited injection site AEs
Unsolicited (spontaneously reported) injection site AEs
Time frame: Within 28 days post-vaccination
Number of participants reporting unsolicited systemic AEs
Unsolicited (spontaneously reported) systemic AEs
Time frame: Between each vaccination and up to 28 days after the last vaccination
Number of participants reporting serious adverse events (SAEs)
SAEs, including adverse event of special interest (AESIs)
Time frame: Up to 6 months post-vaccination
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
RVNA titers will be measured by RFFIT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 14 (post-vaccination)
Number of Participants in Group 3 and Group 4 achieving RVNA titer greater than or equal to (≥) lower limit of quantification
RVNA titers will be measured by RFFIT Lower limit of quantification for RFFIT assay is 0.2 IU/mL
Time frame: Day 14 (post-vaccination)
Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination) in Group 3 and Group 4 Participants
RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 14 RVNA ratios Day14/Day0 will be calculated
Time frame: Day 14 (post-vaccination)
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
RVNA titers will be measured by RFFIT
Time frame: Day 90 (post-vaccination)
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
RVNA titers will be measured by RFFIT Lower limit of quantification for RFFIT assay is 0.2 IU/mL
Time frame: Day 90 (post-vaccination)
Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination) in Group 1, Group 2, Group 5 and Group 6 Participants
RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 90 RVNA ratios Day90/Day0 will be calculated
Time frame: Day 90 (post-vaccination)