Study of Purified Vero Rabies Vaccine Compared With Two Reference Rabies Vaccines, Given in a Pre-exposure Regimen to Children and Adults and as Single Booster Dose to a Subset of Adults
Official Title
Immunogenicity and Safety of a Purified Vero Rabies Vaccine - Serum Free in Comparison With Verorab® and Imovax® Rabies, in a Pre-exposure Regimen in Both Pediatric and Adult Populations and a Single Booster Dose of Purified Vero Rabies Vaccine - Serum Free Administered at 1 Year Post-3-dose Primary Series, and Between 2 up to 3 Years Post-One Week 2-Dose Primary Series in a Subset of Adults in Thailand
Acronym
VRV12
Organization
SanofiINDUSTRY
Status Module
Record Verification Date
Feb 2026
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 21, 2019Actual
Primary Completion Date
Mar 25, 2020Actual
Completion Date
Apr 24, 2025Actual
First Submitted Date
Oct 11, 2019
First Submission Date that Met QC Criteria
Oct 14, 2019
First Posted Date
Oct 16, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Dec 26, 2023
Results First Submitted that Met QC Criteria
Feb 7, 2024
Results First Posted Date
Feb 9, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Sep 13, 2021
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Feb 9, 2024Actual
Last Update Submitted Date
Feb 9, 2026
Last Update Posted Date
Feb 10, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Sanofi Pasteur, a Sanofi CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The primary objective of this study is:
To demonstrate the VRVg-2 is non-inferior to Verorab and Imovax Rabies vaccines in each age group (pediatric and adult populations) when administered as a 3-dose PrEP regimen, in terms of proportion of participants achieving a rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 IU/mL at Day 42, ie. 14 days after the 3rd injection (for Primary Series Cohort 1).
The secondary objectives of this study are: First 1-5 with hypotheses testing will be evaluated sequentially - only if the previous objective is achieved, will the next objective be tested
To demonstrate that:
the observed proportion of participants in the VRVg2(VRVg) group at D42 is at least 99% with a lower limit of the 95% confidence interval (CI) of at least 97%
VRVg is non inferior (NI) to Verorab and Imovax Rabies vaccines (Imovax) in each age group at D28
2-dose VRVg at D28 is NI to 3-dose Imovax at D42 in each age group
the observed proportion of participants in the VRVg group at D28 is at least 99% with a lower limit of the 95% CI of at least 97%
2-dose Imovax at D28 is NI to 3-dose Imovax at D42 in overall participants (Cohort1)
To describe:
the immune response induced by VRVg versus Verorab and Imovax at D28 and at D42 in all age groups
the immune response induced by VRVg at D14 after a booster dose of VRVg administered at M12 (Cohort1) and between M24 up to M36 (Cohort2)
the persistence of immune response at M6,12,18, and pre-booster between M24 up to M36 post-primary series vaccination (Cohort2)
safety profile of VRVg versus Verorab and Imovax in primary series and after a booster dose of VRVg
Detailed Description
The duration of each participant's participation in the primary series Cohort 1 of the study will be approximately 7 months (28 day-vaccination period followed by 6-month safety follow-up period). For the subset of adult participants in Booster Phase Cohort 1 who received a single booster dose of VRVg-2 (1 booster dose 365 days after primary series followed by 6-month safety follow-up period), the duration will be approximately 18 months.
For Primary Series Cohort 2, the duration of each participant's participation in the study will be approximately 7 months (one week vaccination period followed by 6-month safety follow-up period).
For the subset of adult participants in Immunogenicity Persistence and Booster Phase Cohort 2 who will be followed-up for evaluation of immunogenicity persistence after primary series (including blood samples collection at M6, M12, M18, and between 24 up to 36 months) and who will receive a single booster dose of VRVg-2 (after the blood sample collection between 24 up to 36 months), the duration will be approximately 30 to 42 months.
Group 4:VRVg-2 Cohort 2(C2)-1ry Series:Adult participants-Booster Phase:138 adult participants
Experimental
VRVg-2, 2 injections at Day 0 and Day 7
Booster dose of VRVg-2 for a subset of 138 adult participants between Month 24 up to Month 36
Biological: Purified vero rabies vaccine - serum free - VRVg-2
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Purified vero rabies vaccine - serum free - VRVg-2
Biological
Pharmaceutical form: Freeze-dried Route of administration: Intramuscular
Group 2:Verorab C1-1ry Series:pediatric&adult participants-Booster Phase:34 adult participants
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody (RVNA) Titer Greater Than or Equal to (>=) 0.5 IU/mL
RVNA titer against rabies virus was assessed using the Rapid Fluorescent Focus Inhibition test (RFFIT) assay method.
Day 42 (post-vaccination)
Secondary Outcomes
Measure
Description
Time Frame
Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL
RVNA titer against rabies virus was assessed using the RFFIT assay method.
Cohort 1: Day 0 (pre-vaccination), Day 28 and Day 42 (post-vaccination)
Primary Series: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Pooled Population
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Aged ≥1 year on the day of inclusion
Cohort 1 - pediatrics (>1 to 17 years old) and adult (≥18 years old)
Cohort 2 - all adults (≥18 years old)
Informed consent form has been signed and dated by the participant and /or and parent(s) or legally acceptable representative (LAR) and by an independent witness (if required by local regulations), as necessary; and assent form has been signed and dated by the participant, as required
Participant (adult ≥18 years) or participant and parent/LAR (1 year to <18 years) are able to attend all scheduled visits and to comply with all study procedures.
Exclusion Criteria:
Participant is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until 1 month after each vaccination. To be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, or surgically sterile.
Participation at the time of study enrollment or, planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
Receipt of any vaccine in the 4 weeks (28 days) preceding the first study vaccination or planned receipt of any vaccine prior to Visit 5 for pediatric participants and adult participants in Cohort 1, and prior to Visit 4 for adult participants in Cohort 2.
Previous vaccination against rabies (in pre- or post-exposure regimen) with either the study vaccines or another vaccine.
Bite by, or exposure to a potentially rabid animal in the previous 6 months with or 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).
At high risk for rabies exposure during the study.
Known systemic hypersensitivity to any of the study/control vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances.
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 or substance abuse that, in the opinion of the investigator, might interfere with the study conduct or completion.
Chronic illness(1) that, in the opinion of the Investigator, is at a stage where it might interfere with study 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 participant 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 (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
Chronic illness may include, but is not limited to, neurological, cardiopulmonary, gastrointestinal, renal, genitourinary, metabolic, hematologic, auto-immune, or psychiatric disorders or infection
Chokephaibulkit K, Huoi C, Tantawichien T, Mootsikapun P, Kosalaraksa P, Kiertiburanakul S, Ratanasuwan W, Vangelisti M, Laot T, Huang Y, Petit C, Pineda-Pena AC, Frago C. Noninferiority Study of Purified Vero Rabies Vaccine-Serum Free in 3-dose and 2-dose Preexposure Prophylaxis Regimens in Comparison With Licensed Rabies Vaccines. Clin Infect Dis. 2025 Oct 6;81(3):654-666. doi: 10.1093/cid/ciae581.
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
The analysis contains all data in the primary series and booster phase of Cohort (C)-1 and Cohort-2.
Recruitment Details
The study enrolled participants at 4 active sites in Thailand from 21 October 2019 to 23 January 2023. A total of 1708 participants were enrolled and randomized in the study. The study involves 2 phases: Primary series (Cohort 1: 3-dose pre-exposure prophylaxis [PrEP] regimen and Cohort 2: 1-week 2-dose PrEP regimen); and Booster Phase (Cohort 1: booster dose 1 year after first primary series vaccine injection and Cohort 2: Immunogenicity Persistence and Booster Phase Cohort 2).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort-1 Group 1: VRVg-2/VRVg-2
Pediatric and adult participants received 3 intramuscular (IM) injections of Purified Vero Rabies Vaccine - Serum Free (VRVg-2) vaccine at Day 0, Day 7, and Day 28 respectively in the primary series. A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Periods
Title
Milestones
Reasons Not Completed
Primary: C-1: Day[D]0-D28; C-2:D0-D7
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jun 12, 2023
Dec 9, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Primary series will be observer-blinded for both Cohort 1 (3-dose pre-exposure prophylaxis [PrEP] regimen) and Cohort 2 (one week 2-dose PrEP regimen).
Booster phase will be conducted in a blinded manner (vaccine received in the primary series) with an adult subset from Cohort 1 and hereafter referred as "Booster Phase Cohort 1" (with booster dose 1 year after the 1st primary series vaccine injection).
Evaluation of immunogenicity persistence after primary series and a booster phase will be conducted in an open label manner with an adult subset from Cohort 2 and hereafter referred as "Immunogenicity Persistence and Booster Phase Cohort 2" (including blood samples collection at Month 6, Month 12, Month 18, pre-booster between Month 24 up to Month 36, and post-booster between Month 24 up to Month 36+Day 14; and a booster dose between Month 24 up to Month 36).
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Quadruple
Masking Description
For cohort 1 primary series and booster dose and cohort 2 primary series. The study is conducted in an observer-blind manner. Unblinded staff members, independent of the safety evaluation and other study evaluations, prepare and administer the vaccine. The Investigator or delegate in charge of safety assessment as well as the participants are blinded and do not know which vaccine is administered.
In addition to the participants, health care providers, data collectors, outcome assessors (eg, Investigator who assess the safety), the Sponsor personnel (eg, Clinician, Data Management, Biostatistician) will remain blinded until the first statistical analysis.
For cohort 2 immunogenicity persistence and booster phase This phase is open label, however, the laboratory analysts who will be involved in the blood sample testing will remain blinded during the whole study.
Pharmaceutical form: Freeze-dried Route of administration: Intramuscular
Group 3:Imovax Rabies C1-1ry Series:pediatric&adult participants-Booster Phase:34 adult participants
Group 6:Imovax Rabies C2-1ry Series:adult participants-Booster Phase:46 adult participants
RVNA titer against rabies virus was assessed using the RFFIT assay method. At Baseline, Group 1 was equivalent to Group 4 (both groups received VRVg-2), Group 2 was equivalent to Group 5 (both groups received Verorab®), and Group 3 was equivalent to Group 6 (both groups received Imovax Rabies®), therefore it was planned to collect and present pooled data of specified Groups, and separately for adults and pediatric participants in this outcome measure.
Cohort 1: Day 0 (pre-vaccination), Day 28 (post-vaccination); Cohort 2: Day 0 (pre-vaccination) and Day 28 (post-vaccination)
Primary Series: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Pooled Population (Groups 1 and 4) Versus Cohort 1: Group 3: Non-inferiority Analysis
RVNA titer against rabies virus was assessed using the RFFIT assay method. At Baseline, Group 1 was equivalent to Group 4 (both groups received VRVg-2), therefore it was planned to collect and present pooled data of specified Group, and separately for adults and pediatric participants in this outcome measure. Data for this outcome measure was planned to be collected at Day 28 for Pooled Groups 1 and 4 and at Day 42 for Primary Series: Cohort-1 Group 3: Imovax Rabies® and reported as overall data for the non-inferiority analysis in this outcome measure.
Pooled Groups 1 and 4: Day 28 (post-vaccination) and Primary Series: Cohort-1 Group 3: Day 42 (post-vaccination)
Primary Series: Groups 1 and 4: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Pooled Population - Superiority Analysis
RVNA titer against rabies virus was assessed using the RFFIT assay method. At Baseline, Group 1 was equivalent to Group 4 (both groups received VRVg-2), therefore it was planned to collect and present pooled data of specified Group in this outcome measure.
Day 28 (post-vaccination)
Primary Series Cohort 1 Group 3: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Non-Inferiority Analysis
RVNA titer against rabies virus was assessed using the RFFIT assay method.
Cohort 1: Day 28 and Day 42 (post-vaccination)
Primary Series Cohort 1: Rabies Virus Neutralizing Antibody Geometric Mean Titers (GMTs) Against Rabies Virus
RVNA titer against rabies virus was assessed using the RFFIT assay method.
Cohort 1: Day 0 (pre-vaccination), Day 28 and Day 42 (post-vaccination)
Primary Series Cohort 2: Rabies Virus Neutralizing Antibody Geometric Mean Titers (GMTs) Against Rabies Virus
RVNA titer against rabies virus was assessed using the RFFIT assay method.
Cohort 2: Day 0 (pre-vaccination) and Day 28 (post-vaccination)
Primary Series Cohort 2: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL
RVNA titer against rabies virus was assessed using the RFFIT assay method.
Cohort 2: Day 0 (pre-vaccination) and Day 28 (post-vaccination)
Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ])
RVNA titer against rabies virus was assessed using the RFFIT assay method. LLOQ for the RFFIT assay was 0.2 IU/mL.
Cohort 1: Day 0 (pre-vaccination), Day 28 and Day 42 (post-vaccination)
Primary Series Cohort 2: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ])
RVNA titer against rabies virus was assessed using the RFFIT assay method. LLOQ for the RFFIT assay was 0.2 IU/mL.
Cohort 2: Day 0 (pre-vaccination) and Day 28 (post-vaccination)
Primary Series Cohort 1: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers
RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs post-vaccination (i.e., on Day 28 and Day 42) and pre-vaccination on Day 0.
Cohort 1: Day 0 (pre-vaccination), Day 28 and Day 42 (post-vaccination)
Primary Series Cohort 2: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers
RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs post-vaccination (i.e., on Day 28) and pre-vaccination on Day 0.
Cohort 2: Day 0 (pre-vaccination) and Day 28 (post-vaccination)
Primary Series Cohort 1: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization
Virus neutralization was defined as complete (absence of fluorescent cells) and incomplete (presence of fluorescent cells) at the participant/timepoint level at the starting dilution (1/5) of RFFIT assay. Percentage of participants with determined complete and determined incomplete virus neutralization were reported.
Cohort 1: Day 0 (pre-vaccination), Day 28 and Day 42 (post-vaccination)
Primary Series Cohort 2: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization
Virus neutralization was defined as complete (absence of fluorescent cells) and incomplete (presence of fluorescent cells) at the participant/timepoint level at the starting dilution (1/5) of RFFIT assay. Percentage of participants with determined complete and determined incomplete virus neutralization were reported.
Cohort 2: Day 0 (pre-vaccination) and Day 28 (post-vaccination)
Booster Phase: Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus
RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTs were expressed in IU/mL.
Month 12 (pre-booster dose) and Month 12 + Day 14 (post-booster dose)
Booster Phase: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL
RVNA titer against rabies virus was assessed using the RFFIT assay method.
Month 12 (pre-booster dose) and Month 12 + Day 14 (post-booster dose)
Booster Phase: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (LLOQ)
RVNA titer against rabies virus was assessed using the RFFIT assay method. LLOQ for the RFFIT assay was 0.2 IU/mL.
Month 12 (pre-booster dose) and Month 12 + Day 14 (post-booster dose)
Booster Phase: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers
RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs post vaccination (i.e., on Month 12 and Month 12 + Day 14) and pre-vaccination on Day 0, pre-booster dose on Month 12.
Day 0 (pre-vaccination), Month 12 (pre-booster dose) and Month 12 + Day 14 (post-booster dose)
Booster Phase: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization
Virus neutralization was defined as complete (absence of fluorescent cells) and incomplete (presence of fluorescent cells) at the participant/timepoint level at the starting dilution (1/5) of RFFIT assay. Percentage of participants with determined complete and determined incomplete virus neutralization were reported.
Month 12 (pre-booster dose) and Month 12 + Day 14 (post-booster dose)
Booster Phase Cohort 2: Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus
RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTs were expressed in International units/milliliter (IU/mL).
Month 24 up to Month 36 (pre-booster dose) and Month 24 up to Month 36 + Day 14 (post-booster dose)
Booster Phase Cohort 2: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL
RVNA titer against rabies virus was assessed using the RFFIT assay method. Percentages are rounded off to the tenth decimal place.
Month 24 up to Month 36 (pre-booster dose) and Month 24 up to Month 36 + Day 14 (post-booster dose)
Booster Phase Cohort 2: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ])
RVNA titer against rabies virus was assessed using the RFFIT assay method. LLOQ for the RFFIT assay was 0.2 IU/mL. Percentages are rounded off to the tenth decimal place.
Month 24 up to Month 36 (pre-booster dose) and Month 24 up to Month 36 + Day 14 (post-booster dose)
Booster Phase Cohort 2: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers
RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs pre-booster/pre-vaccination (Month 24 up to Month 36/Day 0); post-booster/pre-vaccination (Month 24 up to Month 36 +14 days/Day 0); post-booster/pre-booster (Month 24 up to Month 36+14 days/Month 24 up to Month 36).
Day 0 (pre-vaccination), Month 24 up to Month 36 (pre-booster dose) and Month 24 up to Month 36 + Day 14 (post-booster dose)
Booster Phase Cohort 2: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization
Virus neutralization was defined as complete (absence of fluorescent cells) and incomplete (presence of fluorescent cells) at the participant/timepoint level at the starting dilution (1/5) of RFFIT assay. Percentage of participants with determined complete and determined incomplete virus neutralization were reported. Percentages are rounded off to the tenth decimal place.
Month 24 up to Month 36 (pre-booster dose) and Month 24 up to Month 36 + Day 14 (post-booster dose)
Number of Participants With Immediate Unsolicited Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant who received study vaccine and does not necessarily had to have a causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset post-vaccination. All participants were observed for 30 minutes after any vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB.
Within 30 minutes after any vaccination
Booster Phase Cohort 2: Number of Participants With Immediate Unsolicited Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant who received study vaccine and does not necessarily had to have a causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset post-vaccination. All participants were observed for 30 minutes after any vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB.
Within 30 minutes after any vaccination
Number of Participants With Systemic Reactions
A SR was an expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An AR was all noxious and unintended responses to a medicinal product related to any dose. Solicited systemic reactions included fever, vomiting, crying abnormal, drowsiness, appetite loss, irritability, headache, malaise and myalgia. Solicited systemic reactions were collected by different age groups: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability were collected for participants aged 12 to 23 months. Fever, Headache, Malaise and Myalgia were collected for participants aged >= 2 years.
Within 7 Days after any vaccination
Booster Phase Cohort 2: Number of Participants With Systemic Reactions
A SR was an expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An AR was all noxious and unintended responses to a medicinal product related to any dose. Solicited systemic reactions included fever, vomiting, crying abnormal, drowsiness, appetite loss, irritability, headache, malaise and myalgia. Solicited systemic reactions were collected by different age groups: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability were collected for participants aged 12 to 23 months. Fever, Headache, Malaise and Myalgia were collected for participants aged >= 2 years.
Within 7 Days after any vaccination
Number of Participants With Solicited Injection Site Reactions
A solicited reaction (SR) was an expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An AR was all noxious and unintended responses to a medicinal product related to any dose. Solicited injection site reactions included tenderness/pain, erythema and swelling.
Within 7 Days after any vaccination
Booster Phase Cohort 2: Number of Participants With Solicited Injection Site Reactions
A SR was an expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An AR was all noxious and unintended responses to a medicinal product related to any dose. Solicited injection site reactions included tenderness/pain, erythema and swelling.
Within 7 Days after any vaccination
Number of Participants With Unsolicited Adverse Events
An AE was defined as any untoward medical occurrence in a participant who received study vaccine and does not necessarily had to have a causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRB in terms of diagnosis and/or onset post-vaccination.
Within 28 Days after any vaccination
Booster Phase Cohort 2: Number of Participants With Unsolicited Adverse Events
An AE was defined as any untoward medical occurrence in a participant who received study vaccine and does not necessarily had to have a causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRB in terms of diagnosis and/or onset post-vaccination.
Within 28 Days after any vaccination
Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
An SAEs was any untoward medical occurrence that at any dose resulted in death, life-threatening, initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or a medically important event. An AESI was defined as one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. All SAEs and AESIs occurring during the study that were related to the product administered were reported by the Investigator to the Independent Ethics Committee/Institutional Review Board. Relatedness to study vaccine was based on Investigator's discretion.
From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 & 2 and up to Month 18 for Booster Phase, Cohort 1)
Booster Phase Cohort 2: Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
An SAEs was any untoward medical occurrence that at any dose resulted in death, life-threatening, initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or a medically important event. An AESI was defined as one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. All SAEs and AESIs occurring during the study that were related to the product administered were reported by the Investigator to the Independent Ethics Committee/Institutional Review Board. Relatedness to study vaccine was based on Investigator's discretion.
From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 42)
Bangkok
10400
Thailand
Investigational Site Number : 7640003
Bangkok
10700
Thailand
Investigational Site Number : 7640002
Khon Kaen
40002
Thailand
FG001
Cohort-1 Group 2: Verorab®/VRVg-2
Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively in the primary series. A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
FG002
Cohort-1 Group 3: Imovax Rabies®/VRVg-2
Pediatric and adult participants received 3 IM injections of Imovax Rabies® vaccine at Day 0, Day 7, and Day 28 respectively in primary series. A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
FG003
Cohort-2 Group 4: VRVg-2/VRVg-2
Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively in the primary series. A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.
FG004
Cohort-2 Group 5: Verorab®/VRVg-2
Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively in the primary series. A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.
FG005
Cohort-2 Group 6: Imovax Rabies®/VRVg-2
Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively in the primary series. A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.
FG000607 subjects
FG001203 subjects
FG002200 subjects
FG003420 subjects
FG004139 subjects
FG005139 subjects
Safety Analysis Set (SafAS)
SafAS included participant who had received at least one dose of the study vaccine and were analyzed according to the actual treatment received.
FG000607 subjects
FG001202 subjects
FG002200 subjects
FG003419 subjects
FG004139 subjects
FG005139 subjects
Per-protocol Analysis Set (PPAS) for Day 28
PPAS for Day 28 included all participants who received at least 1 dose of the study vaccine in the primary series, with no relevant protocol deviation before Day 28.
FG000519 subjects
FG001169 subjects
FG002160 subjects
FG003342 subjects
FG004120 subjects
FG005124 subjects
COMPLETED
Completed the active phase of Primary series.
FG000599 subjects
FG001199 subjects
FG002196 subjects
FG003415 subjects
FG004137 subjects
FG005138 subjects
NOT COMPLETED
FG0008 subjects
FG0014 subjects
FG0024 subjects
FG0035 subjects
FG0042 subjects
FG0051 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0051 subjects
Protocol Violation
FG0005 subjects
FG0013 subjects
FG0024 subjects
FG0033 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Withdrawal by Parent/Guardian
FG0002 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Booster:C-1:At Month(M) 12; C-2:M24-M36
Type
Comment
Milestone Data
STARTED
FG00094 subjectsAdult participants who completed the follow-up period, entered the booster phase and received booster dose of VRVg-2.
FG00131 subjectsAdult participants who completed the follow-up period, entered the booster phase and received booster dose of VRVg-2.
FG00232 subjectsAdult participants who completed the follow-up period, entered the booster phase and received booster dose of VRVg-2.
FG003128 subjectsAdult participants who completed the follow-up period, entered the booster phase and received booster dose of VRVg-2.
FG00441 subjectsAdult participants who completed the follow-up period, entered the booster phase and received booster dose of VRVg-2.
FG00543 subjectsAdult participants who completed the follow-up period, entered the booster phase and received booster dose of VRVg-2.
SafAS
FG00094 subjects
FG00131 subjects
FG00232 subjects
FG003128 subjects
FG004
COMPLETED
FG00092 subjects
FG00131 subjects
FG00232 subjects
FG003127 subjects
FG004
NOT COMPLETED
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG003
Analysis was performed on all randomized participants in the primary series cohorts.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Primary Series: Cohort-1 Group 1: VRVg-2
Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.
BG001
Primary Series: Cohort-1 Group 2: Verorab®
Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.
BG002
Primary Series: Cohort-1 Group 3: Imovax Rabies®
Pediatric and adult participants received 3 IM injections of Imovax Rabies® vaccine at Day 0, Day 7, and Day 28 respectively.
BG003
Primary Series: Cohort-2 Group 4: VRVg-2
Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.
BG004
Primary Series: Cohort-2 Group 5: Verorab®
Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.
BG005
Primary Series: Cohort-2 Group 6: Imovax Rabies®
Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000607
BG001203
BG002200
BG003420
BG004139
BG005139
BG0061708
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00022.9± 17.1
BG00122.6± 16.1
BG00222.4± 16.1
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000399
BG001147
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Secondary
Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL
RVNA titer against rabies virus was assessed using the RFFIT assay method.
Analysis was performed on the PPAS for Day 42. Here, 'number analyzed' signifies participants with available data for each specified category.
Posted
Number
95% Confidence Interval
percentage of participants
Cohort 1: Day 0 (pre-vaccination), Day 28 and Day 42 (post-vaccination)
ID
Title
Description
OG000
Primary Series: Cohort-1 Group 1: VRVg-2
Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.
OG001
Primary Series: Cohort-1 Group 2: Verorab®
Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.
OG002
Primary Series: Cohort-1 Group 3: Imovax Rabies®
Pediatric and adult participants received 3 IM injections of Imovax Rabies® vaccine at Day 0, Day 7, and Day 28 respectively.
Units
Counts
Participants
OG000519
OG001169
OG002162
Title
Denominators
Categories
Day 0
ParticipantsOG000519
ParticipantsOG001169
ParticipantsOG002162
Title
Measurements
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
The secondary immunogenicity outcome measures were evaluated sequentially following a fixed-sequence method.
Percentage Difference
100
2-Sided
95
99.3
100
Superiority
If the non-inferiority for VRVg-2 versus comparator vaccines was reached at Day 42, then superiority was demonstrated if the overall observed percentage of participants with an RVNA titer >= 0.5 IU/mL at Day 42 was at least 99% in the VRVg-2 Group, with the lower limit of the 95% CI at least 97%.
Secondary
Primary Series: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Pooled Population
RVNA titer against rabies virus was assessed using the RFFIT assay method. At Baseline, Group 1 was equivalent to Group 4 (both groups received VRVg-2), Group 2 was equivalent to Group 5 (both groups received Verorab®), and Group 3 was equivalent to Group 6 (both groups received Imovax Rabies®), therefore it was planned to collect and present pooled data of specified Groups, and separately for adults and pediatric participants in this outcome measure.
Analysis was performed on the PPAS for Day 28. Here, 'overall number of participants analyzed' signifies participants with available data for this outcome measure and 'number analyzed' signifies participants with available data for each specified category.
Posted
Number
95% Confidence Interval
percentage of participants
Cohort 1: Day 0 (pre-vaccination), Day 28 (post-vaccination); Cohort 2: Day 0 (pre-vaccination) and Day 28 (post-vaccination)
ID
Title
Description
OG000
Pooled Groups 1 and 4: VRVg-2
Included all pediatric and adult participants of Groups 1 and 4 who received VRVg-2 in Cohort 1 or 2.
OG001
Pooled Groups 2 and 5: Verorab®
Included all pediatric and adult participants of Groups 2 and 5 who received Verorab® in Cohort 1 or 2.
OG002
Secondary
Primary Series: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Pooled Population (Groups 1 and 4) Versus Cohort 1: Group 3: Non-inferiority Analysis
RVNA titer against rabies virus was assessed using the RFFIT assay method. At Baseline, Group 1 was equivalent to Group 4 (both groups received VRVg-2), therefore it was planned to collect and present pooled data of specified Group, and separately for adults and pediatric participants in this outcome measure. Data for this outcome measure was planned to be collected at Day 28 for Pooled Groups 1 and 4 and at Day 42 for Primary Series: Cohort-1 Group 3: Imovax Rabies® and reported as overall data for the non-inferiority analysis in this outcome measure.
Analysis was performed on the PPAS that included all participants who received at least 1 dose of the study with no relevant protocol deviation. Here, 'overall number of participants analyzed' signifies participants with available data for this outcome measure and 'number analyzed' signifies participants with available data for each specified category.
Posted
Number
95% Confidence Interval
percentage of participants
Pooled Groups 1 and 4: Day 28 (post-vaccination) and Primary Series: Cohort-1 Group 3: Day 42 (post-vaccination)
ID
Title
Description
OG000
Pooled Groups 1 and 4: VRVg-2
Included all pediatric and adult participants of Groups 1 and 4 who received VRVg-2 in Cohort 1 or 2.
OG001
Primary Series: Cohort-1 Group 3: Imovax Rabies®
Secondary
Primary Series: Groups 1 and 4: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Pooled Population - Superiority Analysis
RVNA titer against rabies virus was assessed using the RFFIT assay method. At Baseline, Group 1 was equivalent to Group 4 (both groups received VRVg-2), therefore it was planned to collect and present pooled data of specified Group in this outcome measure.
Analysis was performed on the PPAS for Day 28.
Posted
Number
95% Confidence Interval
percentage of participants
Day 28 (post-vaccination)
ID
Title
Description
OG000
Pooled Groups 1 and 4: VRVg-2
Included all pediatric and adult participants of Groups 1 and 4 who received VRVg-2 in Cohort 1 or 2.
Units
Counts
Participants
OG000
Secondary
Primary Series Cohort 1 Group 3: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Non-Inferiority Analysis
RVNA titer against rabies virus was assessed using the RFFIT assay method.
Analysis was performed on the PPAS. Here, 'number analyzed' signifies participants with available data for each specified category.
Posted
Number
95% Confidence Interval
percentage of participants
Cohort 1: Day 28 and Day 42 (post-vaccination)
ID
Title
Description
OG000
Primary Series: Cohort-1 Group 3: Imovax Rabies®
Pediatric and adult participants received 3 IM injections of Imovax Rabies® vaccine at Day 0, Day 7, and Day 28 respectively.
Units
Counts
Participants
OG000
Secondary
Primary Series Cohort 1: Rabies Virus Neutralizing Antibody Geometric Mean Titers (GMTs) Against Rabies Virus
RVNA titer against rabies virus was assessed using the RFFIT assay method.
Analysis was performed on the PPAS for Day 42. Here, 'number analyzed' signifies participants with available data for each specified category.
Posted
Geometric Mean
95% Confidence Interval
IU/mL
Cohort 1: Day 0 (pre-vaccination), Day 28 and Day 42 (post-vaccination)
ID
Title
Description
OG000
Primary Series: Cohort-1 Group 1: VRVg-2
Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.
OG001
Primary Series: Cohort-1 Group 2: Verorab®
Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.
OG002
Primary Series: Cohort-1 Group 3: Imovax Rabies®
Pediatric and adult participants received 3 IM injections of Imovax Rabies® vaccine at Day 0, Day 7, and Day 28 respectively.
Secondary
Primary Series Cohort 2: Rabies Virus Neutralizing Antibody Geometric Mean Titers (GMTs) Against Rabies Virus
RVNA titer against rabies virus was assessed using the RFFIT assay method.
Analysis was performed on the PPAS for Day 28 that included all participants who received at least 1 dose of the study vaccine in the primary series, with no relevant protocol deviation before Day 28.
Posted
Geometric Mean
95% Confidence Interval
IU/mL
Cohort 2: Day 0 (pre-vaccination) and Day 28 (post-vaccination)
ID
Title
Description
OG000
Primary Series: Cohort-2 Group 4: VRVg-2
Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.
OG001
Primary Series: Cohort-2 Group 5: Verorab®
Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.
OG002
Primary Series: Cohort-2 Group 6: Imovax Rabies®
Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.
Secondary
Primary Series Cohort 2: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL
RVNA titer against rabies virus was assessed using the RFFIT assay method.
Analysis was performed on PPAS for Day 28.
Posted
Number
95% Confidence Interval
percentage of participants
Cohort 2: Day 0 (pre-vaccination) and Day 28 (post-vaccination)
ID
Title
Description
OG000
Primary Series: Cohort-2 Group 4: VRVg-2
Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.
OG001
Primary Series: Cohort-2 Group 5: Verorab®
Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.
OG002
Primary Series: Cohort-2 Group 6: Imovax Rabies®
Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.
Units
Counts
Participants
Secondary
Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ])
RVNA titer against rabies virus was assessed using the RFFIT assay method. LLOQ for the RFFIT assay was 0.2 IU/mL.
Analysis was performed on the PPAS for Day 42. Here, 'number analyzed' signifies participants with available data for each specified category.
Posted
Number
95% Confidence Interval
percentage of participants
Cohort 1: Day 0 (pre-vaccination), Day 28 and Day 42 (post-vaccination)
ID
Title
Description
OG000
Primary Series: Cohort-1 Group 1: VRVg-2
Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.
OG001
Primary Series: Cohort-1 Group 2: Verorab®
Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.
OG002
Primary Series: Cohort-1 Group 3: Imovax Rabies®
Pediatric and adult participants received 3 IM injections of Imovax Rabies® vaccine at Day 0, Day 7, and Day 28 respectively.
Secondary
Primary Series Cohort 2: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ])
RVNA titer against rabies virus was assessed using the RFFIT assay method. LLOQ for the RFFIT assay was 0.2 IU/mL.
Analysis was performed on the PPAS for Day 28.
Posted
Number
95% Confidence Interval
percentage of participants
Cohort 2: Day 0 (pre-vaccination) and Day 28 (post-vaccination)
ID
Title
Description
OG000
Primary Series: Cohort-2 Group 4: VRVg-2
Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.
OG001
Primary Series: Cohort-2 Group 5: Verorab®
Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.
OG002
Primary Series: Cohort-2 Group 6: Imovax Rabies®
Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.
Units
Secondary
Primary Series Cohort 1: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers
RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs post-vaccination (i.e., on Day 28 and Day 42) and pre-vaccination on Day 0.
Analysis was performed on the PPAS for Day 42. Here, 'number analyzed' signifies participants with available data for each specified category.
Posted
Geometric Mean
95% Confidence Interval
ratio
Cohort 1: Day 0 (pre-vaccination), Day 28 and Day 42 (post-vaccination)
ID
Title
Description
OG000
Primary Series: Cohort-1 Group 1: VRVg-2
Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.
OG001
Primary Series: Cohort-1 Group 2: Verorab®
Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.
OG002
Primary Series: Cohort-1 Group 3: Imovax Rabies®
Pediatric and adult participants received 3 IM injections of Imovax Rabies® vaccine at Day 0, Day 7, and Day 28 respectively.
Secondary
Primary Series Cohort 2: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers
RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs post-vaccination (i.e., on Day 28) and pre-vaccination on Day 0.
Analysis was performed on the PPAS for Day 28.
Posted
Geometric Mean
95% Confidence Interval
ratio
Cohort 2: Day 0 (pre-vaccination) and Day 28 (post-vaccination)
ID
Title
Description
OG000
Primary Series: Cohort-2 Group 4: VRVg-2
Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.
OG001
Primary Series: Cohort-2 Group 5: Verorab®
Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.
OG002
Primary Series: Cohort-2 Group 6: Imovax Rabies®
Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.
Units
Secondary
Primary Series Cohort 1: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization
Virus neutralization was defined as complete (absence of fluorescent cells) and incomplete (presence of fluorescent cells) at the participant/timepoint level at the starting dilution (1/5) of RFFIT assay. Percentage of participants with determined complete and determined incomplete virus neutralization were reported.
Analysis was performed on the PPAS for Day 42. Here, 'number analyzed' signifies participants with available data for each specified category.
Posted
Number
95% Confidence Interval
percentage of participants
Cohort 1: Day 0 (pre-vaccination), Day 28 and Day 42 (post-vaccination)
ID
Title
Description
OG000
Primary Series: Cohort-1 Group 1: VRVg-2
Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.
OG001
Primary Series: Cohort-1 Group 2: Verorab®
Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.
OG002
Primary Series: Cohort-1 Group 3: Imovax Rabies®
Pediatric and adult participants received 3 IM injections of Imovax Rabies® vaccine at Day 0, Day 7, and Day 28 respectively.
Secondary
Primary Series Cohort 2: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization
Virus neutralization was defined as complete (absence of fluorescent cells) and incomplete (presence of fluorescent cells) at the participant/timepoint level at the starting dilution (1/5) of RFFIT assay. Percentage of participants with determined complete and determined incomplete virus neutralization were reported.
Analysis was performed on the PPAS for Day 28. Here, 'number analyzed' signifies participants with available data for each specified category.
Posted
Number
95% Confidence Interval
percentage of participants
Cohort 2: Day 0 (pre-vaccination) and Day 28 (post-vaccination)
ID
Title
Description
OG000
Primary Series: Cohort-2 Group 4: VRVg-2
Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.
OG001
Primary Series: Cohort-2 Group 5: Verorab®
Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.
OG002
Primary Series: Cohort-2 Group 6: Imovax Rabies®
Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.
Secondary
Booster Phase: Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus
RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTs were expressed in IU/mL.
Analysis was performed on PPAS for Booster at Month 12 that included a subset of adults who received a 3 doses regimen and received a single booster dose of VRVg-2 one year after the first vaccination of the primary series (i.e., at Month 12), with no relevant protocol deviation before Month 12 + Day 14.
Posted
Geometric Mean
95% Confidence Interval
IU/mL
Month 12 (pre-booster dose) and Month 12 + Day 14 (post-booster dose)
ID
Title
Description
OG000
Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2)
A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
OG001
Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed)
A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
OG002
Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed)
Secondary
Booster Phase: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL
RVNA titer against rabies virus was assessed using the RFFIT assay method.
Analysis was performed on the PPAS for Booster at Month 12.
Posted
Number
95% Confidence Interval
percentage of participants
Month 12 (pre-booster dose) and Month 12 + Day 14 (post-booster dose)
ID
Title
Description
OG000
Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2)
A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
OG001
Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed)
A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
OG002
Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed)
A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Secondary
Booster Phase: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (LLOQ)
RVNA titer against rabies virus was assessed using the RFFIT assay method. LLOQ for the RFFIT assay was 0.2 IU/mL.
Analysis was performed on the PPAS for Booster at Month 12.
Posted
Number
95% Confidence Interval
percentage of participants
Month 12 (pre-booster dose) and Month 12 + Day 14 (post-booster dose)
ID
Title
Description
OG000
Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2)
A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
OG001
Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed)
A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
OG002
Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed)
A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Secondary
Booster Phase: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers
RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs post vaccination (i.e., on Month 12 and Month 12 + Day 14) and pre-vaccination on Day 0, pre-booster dose on Month 12.
Analysis was performed on the PPAS for Booster at Month 12.
Posted
Geometric Mean
95% Confidence Interval
ratio
Day 0 (pre-vaccination), Month 12 (pre-booster dose) and Month 12 + Day 14 (post-booster dose)
ID
Title
Description
OG000
Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2)
A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
OG001
Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed)
A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
OG002
Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed)
A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Secondary
Booster Phase: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization
Virus neutralization was defined as complete (absence of fluorescent cells) and incomplete (presence of fluorescent cells) at the participant/timepoint level at the starting dilution (1/5) of RFFIT assay. Percentage of participants with determined complete and determined incomplete virus neutralization were reported.
Analysis was performed on the PPAS for Booster at Month 12. Here, 'number analyzed' signifies participants with available data for each specified category.
Posted
Number
95% Confidence Interval
percentage of participants
Month 12 (pre-booster dose) and Month 12 + Day 14 (post-booster dose)
ID
Title
Description
OG000
Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2)
A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
OG001
Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed)
A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
OG002
Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed)
Secondary
Booster Phase Cohort 2: Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus
RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTs were expressed in International units/milliliter (IU/mL).
Results are based on the PPAS for booster between Month 24 up to Month 36 that included a subset of adults who received a 1 week 2-dose regimen and a single booster dose of VRVg-2 between Month 24 and up to Month 36 after the first vaccination of the primary series with no relevant protocol deviation before Month 24 up to Month 36 + Day 14.
Posted
Geometric Mean
95% Confidence Interval
IU/mL
Month 24 up to Month 36 (pre-booster dose) and Month 24 up to Month 36 + Day 14 (post-booster dose)
ID
Title
Description
OG000
Booster Phase: Cohort-2 Group 4: VRVg-2 (Primed With VRVg-2)
A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.
OG001
Booster Phase: Cohort-2 Group 5: VRVg-2 (Verorab® Primed)
A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.
OG002
Secondary
Booster Phase Cohort 2: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL
RVNA titer against rabies virus was assessed using the RFFIT assay method. Percentages are rounded off to the tenth decimal place.
Results are based on the PPAS for booster between Month 24 up to Month 36.
Posted
Number
95% Confidence Interval
percentage of participants
Month 24 up to Month 36 (pre-booster dose) and Month 24 up to Month 36 + Day 14 (post-booster dose)
ID
Title
Description
OG000
Booster Phase: Cohort-2 Group 4: VRVg-2 (Primed With VRVg-2)
A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.
OG001
Booster Phase: Cohort-2 Group 5: VRVg-2 (Verorab® Primed)
A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.
OG002
Booster Phase:Cohort-2 Group 6: VRVg-2 (Imovax Rabies® Primed)
A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.
Secondary
Booster Phase Cohort 2: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ])
RVNA titer against rabies virus was assessed using the RFFIT assay method. LLOQ for the RFFIT assay was 0.2 IU/mL. Percentages are rounded off to the tenth decimal place.
Results are based on the PPAS for booster between Month 24 up to Month 36.
Posted
Number
95% Confidence Interval
percentage of participants
Month 24 up to Month 36 (pre-booster dose) and Month 24 up to Month 36 + Day 14 (post-booster dose)
ID
Title
Description
OG000
Booster Phase: Cohort-2 Group 4: VRVg-2 (Primed With VRVg-2)
A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.
OG001
Booster Phase: Cohort-2 Group 5: VRVg-2 (Verorab® Primed)
A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.
OG002
Booster Phase:Cohort-2 Group 6: VRVg-2 (Imovax Rabies® Primed)
Secondary
Booster Phase Cohort 2: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers
RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs pre-booster/pre-vaccination (Month 24 up to Month 36/Day 0); post-booster/pre-vaccination (Month 24 up to Month 36 +14 days/Day 0); post-booster/pre-booster (Month 24 up to Month 36+14 days/Month 24 up to Month 36).
Results are based on the PPAS for booster between Month 24 up to Month 36.
Posted
Geometric Mean
95% Confidence Interval
ratio
Day 0 (pre-vaccination), Month 24 up to Month 36 (pre-booster dose) and Month 24 up to Month 36 + Day 14 (post-booster dose)
ID
Title
Description
OG000
Booster Phase: Cohort-2 Group 4: VRVg-2 (Primed With VRVg-2)
A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.
OG001
Booster Phase: Cohort-2 Group 5: VRVg-2 (Verorab® Primed)
A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.
OG002
Booster Phase:Cohort-2 Group 6: VRVg-2 (Imovax Rabies® Primed)
Secondary
Booster Phase Cohort 2: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization
Virus neutralization was defined as complete (absence of fluorescent cells) and incomplete (presence of fluorescent cells) at the participant/timepoint level at the starting dilution (1/5) of RFFIT assay. Percentage of participants with determined complete and determined incomplete virus neutralization were reported. Percentages are rounded off to the tenth decimal place.
Results are based on the PPAS for Booster between Month 24 up to Month 36. Here, 'number analyzed' signifies number of participants with available data for this outcome measure for each specified category.
Posted
Number
95% Confidence Interval
percentage of participants
Month 24 up to Month 36 (pre-booster dose) and Month 24 up to Month 36 + Day 14 (post-booster dose)
ID
Title
Description
OG000
Booster Phase: Cohort-2 Group 4: VRVg-2 (Primed With VRVg-2)
A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.
OG001
Booster Phase: Cohort-2 Group 5: VRVg-2 (Verorab® Primed)
A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.
Secondary
Number of Participants With Immediate Unsolicited Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant who received study vaccine and does not necessarily had to have a causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset post-vaccination. All participants were observed for 30 minutes after any vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB.
Analysis was performed on the safety analysis set (SafAS) that included participant who had received at least one dose of the study vaccine and were analyzed according to the actual treatment received.
Posted
Count of Participants
Participants
Within 30 minutes after any vaccination
ID
Title
Description
OG000
Primary Series: Cohort-1 Group 1: VRVg-2
Pediatric and adult participants received 3 intramuscular (IM) injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.
OG001
Primary Series: Cohort-1 Group 2: Verorab®
Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.
OG002
Primary Series: Cohort-1 Group 3: Imovax Rabies®
Secondary
Booster Phase Cohort 2: Number of Participants With Immediate Unsolicited Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant who received study vaccine and does not necessarily had to have a causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset post-vaccination. All participants were observed for 30 minutes after any vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB.
Results are based on the SafAS that included participants who had received at least one dose of the study vaccine and were analyzed according to the actual treatment received.
Posted
Count of Participants
Participants
Within 30 minutes after any vaccination
ID
Title
Description
OG000
Booster Phase: Cohort-2 Group 4: VRVg-2 (Primed With VRVg-2)
A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.
OG001
Booster Phase: Cohort-2 Group 5: VRVg-2 (Verorab® Primed)
A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.
Secondary
Number of Participants With Systemic Reactions
A SR was an expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An AR was all noxious and unintended responses to a medicinal product related to any dose. Solicited systemic reactions included fever, vomiting, crying abnormal, drowsiness, appetite loss, irritability, headache, malaise and myalgia. Solicited systemic reactions were collected by different age groups: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability were collected for participants aged 12 to 23 months. Fever, Headache, Malaise and Myalgia were collected for participants aged >= 2 years.
Analysis was performed on the SafAS. Here, 'number analyzed' signifies participants with available data for each specified category and "0" in the number analyzed denotes that data was not collected and analyzed for the specified category as no pediatric participants were available for analysis in the specified groups.
Posted
Count of Participants
Participants
Within 7 Days after any vaccination
ID
Title
Description
OG000
Primary Series: Cohort-1 Group 1: VRVg-2
Pediatric and adult participants received 3 intramuscular (IM) injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.
OG001
Primary Series: Cohort-1 Group 2: Verorab®
Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.
Secondary
Booster Phase Cohort 2: Number of Participants With Systemic Reactions
A SR was an expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An AR was all noxious and unintended responses to a medicinal product related to any dose. Solicited systemic reactions included fever, vomiting, crying abnormal, drowsiness, appetite loss, irritability, headache, malaise and myalgia. Solicited systemic reactions were collected by different age groups: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability were collected for participants aged 12 to 23 months. Fever, Headache, Malaise and Myalgia were collected for participants aged >= 2 years.
Analysis was performed on the SafAS. Here, 'number analyzed' signifies participants with available data for each specified category and "0" in the number analyzed denotes that data was not collected and analyzed for the specified category as no pediatric participants were available for analysis in the specified groups.
Posted
Count of Participants
Participants
Within 7 Days after any vaccination
ID
Title
Description
OG000
Booster Phase: Cohort-2 Group 4: VRVg-2 (Primed With VRVg-2)
A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.
OG001
Booster Phase: Cohort-2 Group 5: VRVg-2 (Verorab® Primed)
Secondary
Number of Participants With Solicited Injection Site Reactions
A solicited reaction (SR) was an expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An AR was all noxious and unintended responses to a medicinal product related to any dose. Solicited injection site reactions included tenderness/pain, erythema and swelling.
Analysis was performed on the SafAS.
Posted
Count of Participants
Participants
Within 7 Days after any vaccination
ID
Title
Description
OG000
Primary Series: Cohort-1 Group 1: VRVg-2
Pediatric and adult participants received 3 intramuscular (IM) injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.
OG001
Primary Series: Cohort-1 Group 2: Verorab®
Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.
OG002
Primary Series: Cohort-1 Group 3: Imovax Rabies®
Pediatric and adult participants received 3 IM injections of Imovax Rabies® vaccine at Day 0, Day 7, and Day 28 respectively.
Secondary
Booster Phase Cohort 2: Number of Participants With Solicited Injection Site Reactions
A SR was an expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An AR was all noxious and unintended responses to a medicinal product related to any dose. Solicited injection site reactions included tenderness/pain, erythema and swelling.
Results are based on the SafAS.
Posted
Count of Participants
Participants
Within 7 Days after any vaccination
ID
Title
Description
OG000
Booster Phase: Cohort-2 Group 4: VRVg-2 (Primed With VRVg-2)
A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.
OG001
Booster Phase: Cohort-2 Group 5: VRVg-2 (Verorab® Primed)
A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.
OG002
Booster Phase:Cohort-2 Group 6: VRVg-2 (Imovax Rabies® Primed)
Secondary
Number of Participants With Unsolicited Adverse Events
An AE was defined as any untoward medical occurrence in a participant who received study vaccine and does not necessarily had to have a causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRB in terms of diagnosis and/or onset post-vaccination.
Analysis was performed on the safety analysis set (SafAS) that included participant who had received at least one dose of the study vaccine and were analyzed according to the actual treatment received.
Posted
Count of Participants
Participants
Within 28 Days after any vaccination
ID
Title
Description
OG000
Primary Series: Cohort-1 Group 1: VRVg-2
Pediatric and adult participants received 3 intramuscular (IM) injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.
OG001
Primary Series: Cohort-1 Group 2: Verorab®
Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.
OG002
Primary Series: Cohort-1 Group 3: Imovax Rabies®
Pediatric and adult participants received 3 IM injections of Imovax Rabies® vaccine at Day 0, Day 7, and Day 28 respectively.
Secondary
Booster Phase Cohort 2: Number of Participants With Unsolicited Adverse Events
An AE was defined as any untoward medical occurrence in a participant who received study vaccine and does not necessarily had to have a causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRB in terms of diagnosis and/or onset post-vaccination.
Results are based on the SafAS.
Posted
Count of Participants
Participants
Within 28 Days after any vaccination
ID
Title
Description
OG000
Booster Phase: Cohort-2 Group 4: VRVg-2 (Primed With VRVg-2)
A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.
OG001
Booster Phase: Cohort-2 Group 5: VRVg-2 (Verorab® Primed)
A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.
OG002
Booster Phase:Cohort-2 Group 6: VRVg-2 (Imovax Rabies® Primed)
A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.
Secondary
Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
An SAEs was any untoward medical occurrence that at any dose resulted in death, life-threatening, initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or a medically important event. An AESI was defined as one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. All SAEs and AESIs occurring during the study that were related to the product administered were reported by the Investigator to the Independent Ethics Committee/Institutional Review Board. Relatedness to study vaccine was based on Investigator's discretion.
Analysis was performed on SafAS.
Posted
Count of Participants
Participants
From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 & 2 and up to Month 18 for Booster Phase, Cohort 1)
ID
Title
Description
OG000
Primary Series: Cohort-1 Group 1: VRVg-2
Pediatric and adult participants received 3 intramuscular (IM) injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.
OG001
Primary Series: Cohort-1 Group 2: Verorab®
Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.
Secondary
Booster Phase Cohort 2: Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
An SAEs was any untoward medical occurrence that at any dose resulted in death, life-threatening, initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or a medically important event. An AESI was defined as one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. All SAEs and AESIs occurring during the study that were related to the product administered were reported by the Investigator to the Independent Ethics Committee/Institutional Review Board. Relatedness to study vaccine was based on Investigator's discretion.
Results are based on the SafAS.
Posted
Count of Participants
Participants
From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 42)
ID
Title
Description
OG000
Booster Phase: Cohort-2 Group 4: VRVg-2 (Primed With VRVg-2)
A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.
OG001
Booster Phase: Cohort-2 Group 5: VRVg-2 (Verorab® Primed)
A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.
Primary
Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody (RVNA) Titer Greater Than or Equal to (>=) 0.5 IU/mL
RVNA titer against rabies virus was assessed using the Rapid Fluorescent Focus Inhibition test (RFFIT) assay method.
Analysis was performed on the per-protocol analysis set (PPAS) for Day 42 that included all participants who received at least 1 dose of the study vaccine in the primary series, with no relevant protocol deviation before Day 42. Here, 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was planned to be collected and analyzed only for Primary series cohort-1 and separately for adults and pediatric participants.
Posted
Number
95% Confidence Interval
percentage of participants
Day 42 (post-vaccination)
ID
Title
Description
OG000
Primary Series: Cohort-1 Group 1: VRVg-2
Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.
OG001
Primary Series: Cohort-1 Group 2: Verorab®
Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.
OG002
Primary Series: Cohort-1 Group 3: Imovax Rabies®
Time Frame
From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2).
Description
SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Primary Series: Cohort-1 Group 1: VRVg-2
Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.
0
607
10
607
414
607
EG001
Primary Series: Cohort-1 Group 2: Verorab®
Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.
0
202
3
202
121
202
EG002
Primary Series: Cohort-1 Group 3: Imovax Rabies®
Pediatric and adult participants received 3 IM injections of Imovax Rabies® vaccine at Day 0, Day 7, and Day 28 respectively.
0
200
5
200
128
200
EG003
Primary Series: Cohort-2 Group 4: VRVg-2
Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.
0
419
2
419
130
419
EG004
Primary Series: Cohort-2 Group 5: Verorab®
Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.
0
139
0
139
34
139
EG005
Primary Series: Cohort-2 Group 6: Imovax Rabies®
Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.
0
139
1
139
48
139
EG006
Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2)
A subset of adult participants who received 3 IM injections of VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
0
94
2
94
48
94
EG007
Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed)
A subset of adult participants who received 3 IM injections of Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
0
31
0
31
15
31
EG008
Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed)
A subset of adult participants who received 3 IM injections of Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
0
32
1
32
18
32
EG009
Booster Phase: Cohort-2 Group 4: VRVg-2 (Primed With VRVg-2)
A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection ofVRVg-2 in the booster phase between Month 24 up to Month 36.
0
128
3
128
21
128
EG010
Booster Phase: Cohort-2 Group 5: VRVg-2 (Verorab® Primed)
A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.
0
41
0
41
2
41
EG011
Booster Phase:Cohort-2 Group 6: VRVg-2 (Imovax Rabies® Primed)
A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.
0
43
1
43
6
43
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal Pain
Gastrointestinal disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected607 at risk
EG0011 events1 affected202 at risk
EG0020 events0 affected200 at risk
EG0030 events0 affected419 at risk
EG0040 events0 affected139 at risk
EG0050 events0 affected139 at risk
EG0060 events0 affected94 at risk
EG0070 events0 affected31 at risk
EG0080 events0 affected32 at risk
EG0090 events0 affected128 at risk
EG0100 events0 affected41 at risk
EG0110 events0 affected43 at risk
Food Allergy
Immune system disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected607 at risk
EG0011 events1 affected202 at risk
EG0020 events0 affected200 at risk
EG003
Bronchitis
Infections and infestations
MedDra 26.1
Systematic Assessment
EG0001 events1 affected607 at risk
EG0010 events0 affected202 at risk
EG0021 events1 affected200 at risk
EG003
Croup Infectious
Infections and infestations
MedDra 26.1
Systematic Assessment
EG0001 events1 affected607 at risk
EG0010 events0 affected202 at risk
EG0020 events0 affected200 at risk
EG003
Dengue Fever
Infections and infestations
MedDra 26.1
Systematic Assessment
EG0001 events1 affected607 at risk
EG0010 events0 affected202 at risk
EG0020 events0 affected200 at risk
EG003
Gastroenteritis
Infections and infestations
MedDra 26.1
Systematic Assessment
EG0001 events1 affected607 at risk
EG0010 events0 affected202 at risk
EG0020 events0 affected200 at risk
EG003
Infectious Mononucleosis
Infections and infestations
MedDra 26.1
Systematic Assessment
EG0001 events1 affected607 at risk
EG0010 events0 affected202 at risk
EG0020 events0 affected200 at risk
EG003
Influenza
Infections and infestations
MedDra 26.1
Systematic Assessment
EG0000 events0 affected607 at risk
EG0010 events0 affected202 at risk
EG0020 events0 affected200 at risk
EG003
Postoperative Wound Infection
Infections and infestations
MedDra 26.1
Systematic Assessment
EG0000 events0 affected607 at risk
EG0010 events0 affected202 at risk
EG0020 events0 affected200 at risk
EG003
Rhinovirus Infection
Infections and infestations
MedDra 26.1
Systematic Assessment
EG0000 events0 affected607 at risk
EG0011 events1 affected202 at risk
EG0020 events0 affected200 at risk
EG003
Septic Shock
Infections and infestations
MedDra 26.1
Systematic Assessment
EG0000 events0 affected607 at risk
EG0010 events0 affected202 at risk
EG0020 events0 affected200 at risk
EG003
Exposure To Communicable Disease
Injury, poisoning and procedural complications
MedDra 26.1
Systematic Assessment
EG0004 events4 affected607 at risk
EG0010 events0 affected202 at risk
EG0020 events0 affected200 at risk
EG003
Intentional Overdose
Injury, poisoning and procedural complications
MedDra 26.1
Systematic Assessment
EG0000 events0 affected607 at risk
EG0010 events0 affected202 at risk
EG0021 events1 affected200 at risk
EG003
Keratorhexis
Injury, poisoning and procedural complications
MedDra 26.1
Systematic Assessment
EG0000 events0 affected607 at risk
EG0010 events0 affected202 at risk
EG0021 events1 affected200 at risk
EG003
Ligament Injury
Injury, poisoning and procedural complications
MedDra 26.1
Systematic Assessment
EG0000 events0 affected607 at risk
EG0010 events0 affected202 at risk
EG0021 events1 affected200 at risk
EG003
Multiple Fractures
Injury, poisoning and procedural complications
MedDra 26.1
Systematic Assessment
EG0000 events0 affected607 at risk
EG0010 events0 affected202 at risk
EG0020 events0 affected200 at risk
EG003
Road Traffic Accident
Injury, poisoning and procedural complications
MedDra 26.1
Systematic Assessment
EG0000 events0 affected607 at risk
EG0010 events0 affected202 at risk
EG0020 events0 affected200 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected607 at risk
EG0010 events0 affected202 at risk
EG0020 events0 affected200 at risk
EG003
Adenocarcinoma Of The Cervix
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 26.1
Systematic Assessment
EG0000 events0 affected607 at risk
EG0010 events0 affected202 at risk
EG0020 events0 affected200 at risk
EG003
Uterine Leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 26.1
Systematic Assessment
EG0000 events0 affected607 at risk
EG0010 events0 affected202 at risk
EG0020 events0 affected200 at risk
EG003
Headache
Nervous system disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected607 at risk
EG0010 events0 affected202 at risk
EG0020 events0 affected200 at risk
EG003
Hemiplegia
Nervous system disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected607 at risk
EG0010 events0 affected202 at risk
EG0020 events0 affected200 at risk
EG003
Ectopic Pregnancy
Pregnancy, puerperium and perinatal conditions
MedDra 26.1
Systematic Assessment
EG0000 events0 affected607 at risk
EG0010 events0 affected202 at risk
EG0020 events0 affected200 at risk
EG003
Imminent Abortion
Pregnancy, puerperium and perinatal conditions
MedDra 26.1
Systematic Assessment
EG0000 events0 affected607 at risk
EG0010 events0 affected202 at risk
EG0021 events1 affected200 at risk
EG003
Uterine Polyp
Reproductive system and breast disorders
MedDra 26.1
Systematic Assessment
EG0000 events0 affected607 at risk
EG0010 events0 affected202 at risk
EG0020 events0 affected200 at risk
EG003
Chronic Obstructive Pulmonary Disease
Respiratory, thoracic and mediastinal disorders
MedDra 26.1
Systematic Assessment
EG0001 events1 affected607 at risk
EG0010 events0 affected202 at risk
EG0020 events0 affected200 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Injection Site Pain
General disorders
MedDra 26.1
Systematic Assessment
EG000655 events344 affected607 at risk
EG001158 events95 affected202 at risk
EG002191 events106 affected200 at risk
EG003167 events111 affected419 at risk
EG00441 events30 affected139 at risk
EG00563 events43 affected139 at risk
EG00644 events44 affected94 at risk
EG00712 events12 affected31 at risk
EG00817 events17 affected32 at risk
EG00920 events20 affected128 at risk
EG0102 events2 affected41 at risk
EG0116 events6 affected43 at risk
Injection Site Swelling
General disorders
MedDra 26.1
Systematic Assessment
EG00019 events14 affected607 at risk
EG0014 events4 affected202 at risk
EG00218 events13 affected200 at risk
EG003
Malaise
General disorders
MedDra 26.1
Systematic Assessment
EG000229 events161 affected607 at risk
EG00157 events45 affected202 at risk
EG00279 events48 affected200 at risk
EG003
Pyrexia
General disorders
MedDra 26.1
Systematic Assessment
EG00054 events51 affected607 at risk
EG00112 events12 affected202 at risk
EG0025 events5 affected200 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDra 26.1
Systematic Assessment
EG00027 events27 affected607 at risk
EG0019 events9 affected202 at risk
EG00214 events12 affected200 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDra 26.1
Systematic Assessment
EG000405 events249 affected607 at risk
EG001103 events67 affected202 at risk
EG002135 events79 affected200 at risk
EG003
Headache
Nervous system disorders
MedDra 26.1
Systematic Assessment
EG000178 events130 affected607 at risk
EG00166 events50 affected202 at risk
EG00262 events47 affected200 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable participant matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
Included all pediatric and adult participants of Groups 3 and 6 who received Imovax Rabies® in Cohort 1 or 2.
Units
Counts
Participants
OG000861
OG001289
OG002284
Title
Denominators
Categories
Pediatric (< 18 years)
ParticipantsOG000266
ParticipantsOG00186
ParticipantsOG00281
Title
Measurements
OG000100(98.6 to 100)
OG001100(95.8 to 100)
OG002100(95.5 to 100)
Adult (>= 18 years)
ParticipantsOG000595
ParticipantsOG001203
ParticipantsOG002203
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Pooled Groups 1 and 4: VRVg-2 versus Pooled Groups 2 and 5: Verorab®: Pediatric (< 18 years)
Percentage Difference
0
2-Sided
95
-1.4
4.3
Non-Inferiority
Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentage between the test groups (Groups 1+4) and control groups (Groups 2+5, Groups 3+6) was > -5% at Day 28.
OG000
OG001
Pooled Groups 1 and 4: VRVg-2 versus Pooled Groups 2 and 5: Verorab®: Adult (>=18 years)
Percentage Difference
-0.2
2-Sided
95
-1.9
2.7
Non-Inferiority
Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentage between the test groups (Groups 1+4) and control groups (Groups 2+5, Groups 3+6) was > -5% at Day 28.
OG000
OG002
Pooled Groups 1 and 4: VRVg-2 versus Pooled Groups 3 and 6: Imovax Rabies®: Pediatric (< 18 years)
Percentage Difference
0
2-Sided
95
-1.4
4.5
Non-Inferiority
Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentage between the test groups (Groups 1+4) and control groups (Groups 2+5, Groups 3+6) was > -5% at Day 28.
OG000
OG002
Pooled Groups 1 and 4: VRVg-2 versus Pooled Groups 3 and 6: Imovax Rabies®: Adult (>= 18 years)
Percentage Difference
1.8
2-Sided
95
-0.5
5.3
Non-Inferiority
Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentage between the test groups (Groups 1+4) and control groups (Groups 2+5, Groups 3+6) was > -5% at Day 28.
Pediatric and adult participants received 3 IM injections of Imovax Rabies® vaccine at Day 0, Day 7, and Day 28 respectively.
Units
Counts
Participants
OG000861
OG001162
Title
Denominators
Categories
Pediatric (< 18 years)
ParticipantsOG000266
ParticipantsOG00183
Title
Measurements
OG000100(98.6 to 100)
OG001100(95.7 to 100)
Adult (>= 18 years)
ParticipantsOG000595
ParticipantsOG00179
Title
Measurements
OG00098.3(96.9 to 99.2)
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Pooled Groups 1 and 4: VRVg-2 at Day 28 versus Primary Series: Cohort-1 Group 3: Imovax Rabies® at Day 42: Pediatric (< 18 years)
Percentage Difference
0
2-Sided
95
-1.4
4.4
Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentage between 2-dose VRVg-2 at Day 28 and 3-dose Imovax Rabies® at Day 42 was > -10%.
Non-Inferiority
If the non-inferiority objective for VRVg-2 versus comparator vaccines at Day 28 was demonstrated, the overall non-inferiority of 2-dose VRVg-2 at Day 28 versus 3-dose Imovax Rabies® at Day 42 was demonstrated if the non-inferiority between pooled Groups 1+4 and Group 3 were both demonstrated in each age group.
OG000
OG001
Pooled Groups 1 and 4: VRVg-2 at Day 28 versus Primary Series: Cohort-1 Group 3: Imovax Rabies® at Day 42: Adult (>= 18 years)
Percentage Difference
-1.7
2-Sided
95
-3.1
3.0
Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentage between 2-dose VRVg-2 at Day 28 and 3-dose Imovax Rabies® at Day 42 was > -10%.
Non-Inferiority
If the non-inferiority objective for VRVg-2 versus comparator vaccines at Day 28 was demonstrated, the overall non-inferiority of 2-dose VRVg-2 at Day 28 versus 3-dose Imovax Rabies® at Day 42 was demonstrated if the non-inferiority between pooled Groups 1+4 and Group 3 were both demonstrated in each age group.
861
Title
Denominators
Categories
Title
Measurements
OG00098.8(97.9 to 99.4)
162
Title
Denominators
Categories
Day 0
ParticipantsOG000162
Title
Measurements
OG0000(0 to 2.3)
Day 28
ParticipantsOG000160
Title
Measurements
OG00098.8(95.6 to 99.8)
Day 42
ParticipantsOG000162
Title
Measurements
OG000100(97.7 to 100)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Imovax Rabies® at Day 28 versus Imovax Rabies® at Day 42
Percentage Difference
-1.3
2-Sided
95
-4.4
1.3
Non-Inferiority
If the superiority objective of VRVg-2 was reached at Day 28, the non-inferiority of 2-dose Imovax Rabies® at Day 28 versus 3-dose Imovax Rabies® at Day 42 was demonstrated if the lower limit of the 95% CI of the difference of the percentage between the 2-dose Imovax Rabies® at Day 28 and 3-dose Imovax Rabies® at Day 42 was > -10%.
Units
Counts
Participants
OG000519
OG001169
OG002162
Title
Denominators
Categories
Day 0
ParticipantsOG000519
ParticipantsOG001169
ParticipantsOG002162
Title
Measurements
OG0000.100(0.100 to 0.100)
OG0010.101(0.100 to 0.102)
OG0020.101(0.100 to 0.101)
Day 28
ParticipantsOG000512
ParticipantsOG001168
ParticipantsOG002160
Title
Measurements
OG000
Day 42
ParticipantsOG000519
ParticipantsOG001169
ParticipantsOG002162
Title
Measurements
OG000
Units
Counts
Participants
OG000342
OG001120
OG002124
Title
Denominators
Categories
Day 0
Title
Measurements
OG0000.101(0.100 to 0.101)
OG0010.101(0.100 to 0.101)
OG0020.100(0.100 to 0.101)
Day 28
Title
Measurements
OG0003.79(3.42 to 4.20)
OG0012.92(2.45 to 3.48)
OG0023.91(3.25 to 4.70)
OG000342
OG001120
OG002124
Title
Denominators
Categories
Day 0
Title
Measurements
OG0000(0.0 to 1.1)
OG0010(0.0 to 3.0)
OG0020(0.0 to 2.9)
Day 28
Title
Measurements
OG00097.1(94.7 to 98.6)
OG00198.3(94.1 to 99.8)
OG00296.0(90.8 to 98.7)
Units
Counts
Participants
OG000519
OG001169
OG002162
Title
Denominators
Categories
Day 0
ParticipantsOG000519
ParticipantsOG001169
ParticipantsOG002162
Title
Measurements
OG0000(0 to 0.7)
OG0010(0 to 2.2)
OG0020(0 to 2.3)
Day 28
ParticipantsOG000519
ParticipantsOG001168
ParticipantsOG002160
Title
Measurements
OG000
Day 42
ParticipantsOG000519
ParticipantsOG001169
ParticipantsOG002162
Title
Measurements
OG000
Counts
Participants
OG000342
OG001120
OG002124
Title
Denominators
Categories
Day 0
Title
Measurements
OG0000(0 to 1.1)
OG0010(0 to 3.0)
OG0020(0 to 2.9)
Day 28
Title
Measurements
OG00099.7(98.4 to 100)
OG001100(97.0 to 100)
OG00298.4(94.3 to 99.8)
Units
Counts
Participants
OG000519
OG001169
OG002162
Title
Denominators
Categories
Day 28/Day 0
ParticipantsOG000512
ParticipantsOG001168
ParticipantsOG002160
Title
Measurements
OG00071.5(66.6 to 76.8)
OG00148.7(42.8 to 55.3)
OG00251.0(44.6 to 58.3)
Day 42/Day 0
ParticipantsOG000519
ParticipantsOG001169
ParticipantsOG002162
Title
Measurements
OG000
Counts
Participants
OG000342
OG001120
OG002124
Title
Denominators
Categories
Title
Measurements
OG00037.7(34.0 to 41.8)
OG00129.0(24.4 to 34.6)
OG00238.9(32.4 to 46.7)
Units
Counts
Participants
OG000519
OG001169
OG002162
Title
Denominators
Categories
Day 0 - Complete neutralization
ParticipantsOG000504
ParticipantsOG001166
ParticipantsOG002158
Title
Measurements
OG0000.2(0 to 1.1)
OG0010.6(0 to 3.3)
OG0021.3(0.2 to 4.5)
Day 0 - Incomplete neutralization
ParticipantsOG000504
ParticipantsOG001166
ParticipantsOG002158
Title
Measurements
OG000
Day 28 - Complete neutralization
ParticipantsOG000514
ParticipantsOG001167
ParticipantsOG002161
Title
Measurements
OG000
Day 28 - Incomplete neutralization
ParticipantsOG000514
ParticipantsOG001167
ParticipantsOG002161
Title
Measurements
OG000
Day 42 - Complete neutralization
ParticipantsOG000518
ParticipantsOG001169
ParticipantsOG002161
Title
Measurements
OG000
Day 42 - Incomplete neutralization
ParticipantsOG000518
ParticipantsOG001169
ParticipantsOG002161
Title
Measurements
OG000
Units
Counts
Participants
OG000342
OG001120
OG002124
Title
Denominators
Categories
Day 0 - Complete neutralization
ParticipantsOG000330
ParticipantsOG001119
ParticipantsOG002117
Title
Measurements
OG0000.9(0.2 to 2.6)
OG0014.2(1.4 to 9.5)
OG0020(0 to 3.1)
Day 0 - Incomplete neutralization
ParticipantsOG000330
ParticipantsOG001119
ParticipantsOG002117
Title
Measurements
OG000
Day 28 - Complete neutralization
ParticipantsOG000339
ParticipantsOG001120
ParticipantsOG002124
Title
Measurements
OG000
Day 28 - Incomplete neutralization
ParticipantsOG000339
ParticipantsOG001120
ParticipantsOG002124
Title
Measurements
OG000
A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Units
Counts
Participants
OG00080
OG00126
OG00228
Title
Denominators
Categories
Month 12
Title
Measurements
OG0000.679(0.526 to 0.878)
OG0010.540(0.344 to 0.848)
OG0020.487(0.311 to 0.764)
Month 12 + 14 Days
Title
Measurements
OG00056.5(45.4 to 70.3)
OG00157.1(42.6 to 76.7)
OG00233.7(22.6 to 50.3)
Units
Counts
Participants
OG00080
OG00126
OG00228
Title
Denominators
Categories
Month 12
Title
Measurements
OG00053.8(42.2 to 65.0)
OG00153.8(33.4 to 73.4)
OG00235.7(18.6 to 55.9)
Month 12 + 14 days
Title
Measurements
OG000100(95.5 to 100)
OG001100(86.8 to 100)
OG002100(87.7 to 100)
Units
Counts
Participants
OG00080
OG00126
OG00228
Title
Denominators
Categories
Month 12
Title
Measurements
OG00086.3(76.7 to 92.9)
OG00176.9(56.4 to 91.0)
OG00285.7(67.3 to 96.0)
Month 12 + 14 days
Title
Measurements
OG000100(95.5 to 100)
OG001100(86.8 to 100)
OG002100(87.7 to 100)
Units
Counts
Participants
OG00080
OG00126
OG00228
Title
Denominators
Categories
Month 12/Day 0
Title
Measurements
OG0006.79(5.26 to 8.78)
OG0015.40(3.44 to 8.48)
OG0024.78(3.10 to 7.37)
Month 12+14 days/Day 0
Title
Measurements
OG000565(454 to 703)
OG001571(426 to 767)
OG002331(219 to 500)
Month 12+14 days/Month 12
Title
Measurements
OG00083.2(62.0 to 112)
OG001106(62.7 to 178)
OG00269.2(39.6 to 121)
A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Units
Counts
Participants
OG00080
OG00126
OG00228
Title
Denominators
Categories
Month 12 - Complete neutralization
ParticipantsOG00077
ParticipantsOG00125
ParticipantsOG00223
Title
Measurements
OG00096.1(89.0 to 99.2)
OG00184.0(63.9 to 95.5)
OG00295.7(78.1 to 99.9)
Month 12 - Incomplete neutralization
ParticipantsOG00077
ParticipantsOG00125
ParticipantsOG00223
Title
Measurements
OG000
Month 12 + 14 days - Complete neutralization
ParticipantsOG00080
ParticipantsOG00126
ParticipantsOG00227
Title
Measurements
OG000
Month 12 + 14 days - Incomplete neutralization
ParticipantsOG00080
ParticipantsOG00126
ParticipantsOG00227
Title
Measurements
OG000
Booster Phase:Cohort-2 Group 6: VRVg-2 (Imovax Rabies® Primed)
A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.
Units
Counts
Participants
OG000108
OG00133
OG00237
Title
Denominators
Categories
Month 24 up to Month 36
Title
Measurements
OG0000.761(0.607 to 0.953)
OG0010.536(0.385 to 0.747)
OG0020.903(0.603 to 1.35)
Month 24 up to Month 36 + 14 Days
Title
Measurements
OG00095.4(76.7 to 119)
OG00189.4(55.8 to 143)
OG00264.7(43.7 to 95.9)
Units
Counts
Participants
OG000108
OG00133
OG00237
Title
Denominators
Categories
Month 24 up to Month 36
Title
Measurements
OG00062.0(52.2 to 71.2)
OG00151.5(33.5 to 69.2)
OG00264.9(47.5 to 79.8)
Month 24 up to Month 36 + 14 Days
Title
Measurements
OG000100(96.6 to 100)
OG001100(89.4 to 100)
OG002100(90.5 to 100)
A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.
Units
Counts
Participants
OG000108
OG00133
OG00237
Title
Denominators
Categories
Month 24 up to Month 36
Title
Measurements
OG00089.8(82.5 to 94.8)
OG00187.9(71.8 to 96.6)
OG00289.2(74.6 to 97.0)
Month 24 up to Month 36 + 14 Days
Title
Measurements
OG000100(96.6 to 100)
OG001100(89.4 to 100)
OG002100(90.5 to 100)
A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.
Units
Counts
Participants
OG000108
OG00133
OG00237
Title
Denominators
Categories
Month 24 up to Month 36/Day 0
Title
Measurements
OG0007.58(6.06 to 9.48)
OG0015.30(3.80 to 7.40)
OG0029.03(6.03 to 13.5)
Month 24 up to Month 36 +14 days/Day 0
Title
Measurements
OG000951(764 to 1184)
OG001885(548 to 1430)
OG002647(437 to 959)
Month 24 up to Month 36+14 days/Month 24 up to Month 36
Title
Measurements
OG000125(98.1 to 160)
OG001167(101 to 276)
OG00271.7(42.3 to 122)
OG002
Booster Phase:Cohort-2 Group 6: VRVg-2 (Imovax Rabies® Primed)
A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.
Units
Counts
Participants
OG000108
OG00133
OG00237
Title
Denominators
Categories
Month 24 up to Month 36- Complete neutralization
ParticipantsOG000107
ParticipantsOG00133
ParticipantsOG00237
Title
Measurements
OG00094.1(87.5 to 97.8)
OG00193.8(79.2 to 99.2)
OG00291.9(78.1 to 98.3)
Month 24 up to Month 36- Incomplete neutralization
ParticipantsOG000107
ParticipantsOG00133
ParticipantsOG00237
Title
Measurements
OG000
Month 24 up to Month 36 + 14 days- Complete neutralization
ParticipantsOG000108
ParticipantsOG00133
ParticipantsOG00237
Title
Measurements
OG000
Month 24 up to Month 36 + 14 days- Incomplete neutralization
ParticipantsOG000108
ParticipantsOG00133
ParticipantsOG00237
Title
Measurements
OG000
Pediatric and adult participants received 3 IM injections of Imovax Rabies® vaccine at Day 0, Day 7, and Day 28 respectively.
OG003
Primary Series: Cohort-2 Group 4: VRVg-2
Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.
OG004
Primary Series: Cohort-2 Group 5: Verorab®
Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.
OG005
Primary Series: Cohort-2 Group 6: Imovax Rabies®
Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.
OG006
Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2)
A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
OG007
Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed)
A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
OG008
Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed)
A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Units
Counts
Participants
OG000607
OG001202
OG002200
OG003419
OG004139
OG005139
OG00694
OG00731
OG00832
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG002
Booster Phase:Cohort-2 Group 6: VRVg-2 (Imovax Rabies® Primed)
A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.
Units
Counts
Participants
OG000128
OG00141
OG00243
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG002
Primary Series: Cohort-1 Group 3: Imovax Rabies®
Pediatric and adult participants received 3 IM injections of Imovax Rabies® vaccine at Day 0, Day 7, and Day 28 respectively.
OG003
Primary Series: Cohort-2 Group 4: VRVg-2
Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.
OG004
Primary Series: Cohort-2 Group 5: Verorab®
Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.
OG005
Primary Series: Cohort-2 Group 6: Imovax Rabies®
Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.
OG006
Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2)
A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
OG007
Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed)
A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
OG008
Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed)
A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Units
Counts
Participants
OG000607
OG001202
OG002200
OG003419
OG004139
OG005139
OG00694
OG00731
OG00832
Title
Denominators
Categories
Fever
ParticipantsOG000606
ParticipantsOG001201
ParticipantsOG002200
ParticipantsOG003419
ParticipantsOG004139
ParticipantsOG005139
ParticipantsOG00694
ParticipantsOG00731
ParticipantsOG00832
Title
Measurements
OG00050
OG00111
OG0024
OG003
Vomiting
ParticipantsOG00017
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0030
Crying abnormal
ParticipantsOG00017
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0030
Drowsiness
ParticipantsOG00017
ParticipantsOG001202
ParticipantsOG0022
ParticipantsOG0030
Appetite lost
ParticipantsOG00017
ParticipantsOG001202
ParticipantsOG0022
ParticipantsOG0030
Irritability
ParticipantsOG00017
ParticipantsOG001202
ParticipantsOG0022
ParticipantsOG0030
Headache
ParticipantsOG000590
ParticipantsOG001199
ParticipantsOG002198
ParticipantsOG003419
Malaise
ParticipantsOG000590
ParticipantsOG001199
ParticipantsOG002198
ParticipantsOG003419
Myalgia
ParticipantsOG000590
ParticipantsOG001199
ParticipantsOG002198
ParticipantsOG003419
A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.
OG002
Booster Phase:Cohort-2 Group 6: VRVg-2 (Imovax Rabies® Primed)
A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.
Units
Counts
Participants
OG000128
OG00141
OG00243
Title
Denominators
Categories
Fever
ParticipantsOG000128
ParticipantsOG00141
ParticipantsOG00243
Title
Measurements
OG0000
OG0010
OG0020
Vomiting
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
Crying abnormal
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
Drowsiness
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
Appetite lost
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
Irritability
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
Headache
ParticipantsOG000128
ParticipantsOG00141
ParticipantsOG00243
Title
Measurements
OG000
Malaise
ParticipantsOG000128
ParticipantsOG00141
ParticipantsOG00243
Title
Measurements
OG000
Myalgia
ParticipantsOG000128
ParticipantsOG00141
ParticipantsOG00243
Title
Measurements
OG000
OG003
Primary Series: Cohort-2 Group 4: VRVg-2
Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.
OG004
Primary Series: Cohort-2 Group 5: Verorab®
Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.
OG005
Primary Series: Cohort-2 Group 6: Imovax Rabies®
Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.
OG006
Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2)
A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
OG007
Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed)
A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
OG008
Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed)
A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Units
Counts
Participants
OG000607
OG001202
OG002200
OG003419
OG004139
OG005139
OG00694
OG00731
OG00832
Title
Denominators
Categories
Injection site tenderness/pain
Title
Measurements
OG000344
OG00195
OG002106
OG003111
OG00430
OG00543
OG00644
OG00712
OG00817
Injection site erythema
Title
Measurements
OG00024
OG0016
OG0026
OG003
Injection site swelling
Title
Measurements
OG00014
OG0014
OG00213
OG003
A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.
Units
Counts
Participants
OG000128
OG00141
OG00243
Title
Denominators
Categories
Injection site tenderness/pain
Title
Measurements
OG00020
OG0012
OG0026
Injection site erythema
Title
Measurements
OG0000
OG0010
OG0020
Injection site swelling
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary Series: Cohort-2 Group 4: VRVg-2
Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.
OG004
Primary Series: Cohort-2 Group 5: Verorab®
Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.
OG005
Primary Series: Cohort-2 Group 6: Imovax Rabies®
Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.
OG006
Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2)
A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
OG007
Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed)
A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
OG008
Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed)
A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Units
Counts
Participants
OG000607
OG001202
OG002200
OG003419
OG004139
OG005139
OG00694
OG00731
OG00832
Title
Denominators
Categories
Title
Measurements
OG000137
OG00145
OG00240
OG00344
OG00418
OG00512
OG00613
OG0073
OG0085
Units
Counts
Participants
OG000128
OG00141
OG00243
Title
Denominators
Categories
Title
Measurements
OG00015
OG0011
OG0023
OG002
Primary Series: Cohort-1 Group 3: Imovax Rabies®
Pediatric and adult participants received 3 IM injections of Imovax Rabies® vaccine at Day 0, Day 7, and Day 28 respectively.
OG003
Primary Series: Cohort-2 Group 4: VRVg-2
Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.
OG004
Primary Series: Cohort-2 Group 5: Verorab®
Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.
OG005
Primary Series: Cohort-2 Group 6: Imovax Rabies®
Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.
OG006
Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2)
A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
OG007
Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed)
A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
OG008
Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed)
A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Units
Counts
Participants
OG000607
OG001202
OG00220
OG003419
OG004139
OG005139
OG00694
OG00731
OG00832
Title
Denominators
Categories
SAEs
Title
Measurements
OG00010
OG0013
OG0025
OG0032
OG0040
OG0051
OG0062
OG0070
OG0081
AESIs
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG002
Booster Phase:Cohort-2 Group 6: VRVg-2 (Imovax Rabies® Primed)
A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.
Units
Counts
Participants
OG000128
OG00141
OG00243
Title
Denominators
Categories
SAEs
Title
Measurements
OG0003
OG0010
OG0021
AESIs
Title
Measurements
OG0000
OG0010
OG0020
Pediatric and adult participants received 3 IM injections of Imovax Rabies® vaccine at Day 0, Day 7, and Day 28 respectively.
Units
Counts
Participants
OG000519
OG001169
OG002162
Title
Denominators
Categories
Pediatric (< 18 years)
ParticipantsOG000265
ParticipantsOG00185
ParticipantsOG00283
Title
Measurements
OG000100(98.6 to 100)
OG001100(95.8 to 100)
OG002100(95.7 to 100)
Adult (>= 18 years)
ParticipantsOG000254
ParticipantsOG00184
ParticipantsOG00279
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Primary Series: Cohort-I Group 1: VRVg-2 versus Primary Series: Cohort-I Group 2: Verorab®: Pediatric (< 18 years)
Percentage Difference
0
2-Sided
95
-1.4
4.3
Non-Inferiority
Non-inferiority was demonstrated if the lower limit of the 95 percent (%) confidence interval (CI) of the difference of the percentages between the test group (Group 1) and control groups (Group 2, Group 3) was greater than (>) -5% at Day 42.
OG000
OG001
Primary Series: Cohort-I Group 1: VRVg-2 versus Primary Series: Cohort-I Group 2: Verorab®: Adult (>=18 years)
Percentage Difference
1.2
2-Sided
95
-0.6
6.4
Non-Inferiority
Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentages between the test group (Group 1) and control groups (Group 2, Group 3) was > -5% at Day 42.
OG000
OG002
Primary Series: Cohort-I Group 1: VRVg-2 versus Primary Series: Cohort-I Group 3: Imovax Rabies: Pediatric (< 18 years)
Percentage Difference
0
2-Sided
95
-1.4
4.4
Non-Inferiority
Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentages between the test group (Group 1) and control groups (Group 2, Group 3) was > -5% at Day 42.
OG000
OG002
Primary Series: Cohort-I Group 1: VRVg-2 versus Primary Series: Cohort-I Group 3: Imovax Rabies: Adult (>= 18 years)
Percentage Difference
0
2-Sided
95
-1.5
4.6
Non-Inferiority
Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentages between the test group (Group 1) and control groups (Group 2, Group 3) was > -5% at Day 42.