A phase 3 clinical trial to evaluate long-term immunogenicity and boostability of Purified Chick-Embryo Cell Rabies Vaccine in adults following primary series of pre/exposure prophylaxis.
Trial overview
Number of participants reporting serious adverse events (SAEs) after a booster dose of purified chick embryo cell culture (PCEC) rabies vaccine
Timeframe: From booster vaccination [6 to 9 months after Year 3 (3 years after primary series of vaccination)] up until completion of the safety follow-up period (10 years after primary series of vaccination)
Number of participants who had their Rabies Virus Neutralizing Antibody (RNVA) concentrations drop below 0.5 international units (IU) per milliliter (mL) between Day 366 and Year 3
Timeframe: Day 366 to Year 3 (after primary series of vaccination)
Number of participants who had their RNVA concentrations drop below 0.5 IU/mL between Year 3 and Year 4
Timeframe: Year 3 to Year 4 (after primary series of vaccination)
Number of participants who had their RNVA concentrations drop below 0.5 IU/mL between Year 4 and Year 5
Timeframe: Year 4 to Year 5 (after primary series of vaccination)
Number of participants who had their RNVA concentrations drop below 0.5 IU/mL between Year 5 and Year 6
Timeframe: Year 5 to Year 6 (after primary series of vaccination)
Number of participants who had their RNVA concentrations drop below 0.5 IU/mL between Year 6 and Year 7
Timeframe: Year 6 to Year 7 (after primary series of vaccination)
Number of participants who had their RNVA concentrations drop below 0.5 IU/mL between Year 7 and Year 8
Timeframe: Year 7 to Year 8 (after primary series of vaccination)
Number of participants who had their RNVA concentrations drop below 0.5 IU/mL between Year 8 and Year 9
Timeframe: Year 8 to Year 9 (after primary series of vaccination)
Number of participants who had their RNVA concentrations drop below 0.5 IU/mL between Year 9 and Year 10
Timeframe: Year 9 to Year 10 (after primary series of vaccination)
RVNA antibody concentrations 7 days after the booster dose
Timeframe: At Day 7 after booster dose
RVNA Geometric Mean Ratios (GMRs) 7 days after the booster dose versus antibody concentrations before the booster dose
Timeframe: Day 7 after booster dose compared to baseline (7 days before booster dose)
Percentage of participants with RVNA concentrations greater than or equal to (>=) 0.5 IU/mL, 7 days after booster dose
Timeframe: At Day 7 after booster dose
Percentage of participants with RVNA concentrations >= 0.5 IU/mL at Year 3
Timeframe: At Year 3 after primary series of vaccine administration
Percentage of participants with RVNA concentrations >= 0.5 IU/mL at Year 4
Timeframe: At Year 4 after primary series of vaccine administration
Percentage of participants with RVNA concentrations >= 0.5 IU/mL at Year 5
Timeframe: At Year 5 after primary series of vaccine administration
Percentage of participants with RVNA concentrations >= 0.5 IU/mL at Year 6
Timeframe: At Year 6 after primary series of vaccine administration
Percentage of participants with RVNA concentrations >= 0.5 IU/mL at Year 7
Timeframe: At Year 7 after primary series of vaccine administration
Percentage of participants with RVNA concentrations >= 0.5 IU/mL at Year 8
Timeframe: At Year 8 after primary series of vaccine administration
Percentage of participants with RVNA concentrations >= 0.5 IU/mL at Year 9
Timeframe: At Year 9 after primary series of vaccine administration
Percentage of participants with RVNA concentrations >= 0.5 IU/mL at Year 10
Timeframe: At Year 10 after primary series of vaccine administration
Rabies Virus Neutralizing Antibody concentrations
Timeframe: At Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and Year 10 after primary series of vaccine administration
Reverse Cumulative percentage for participants with RVNA concentrations >=0.5 IU/mL
Timeframe: At Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9 and Year 10 after primary series of vaccine administration
Participation criteria
- All individuals who were randomized to a Rabies primary series vaccination for pre-exposure prophylaxis (PrEP), received the full PrEP regimen and completed the parent trial following study protocol.
- Completed the parent study without receiving the full 3 rabies vaccine doses
- following the assigned pre-exposure prophylaxis regimen.
- All individuals who were randomized to a Rabies primary series vaccination for pre-exposure prophylaxis (PrEP), received the full PrEP regimen and completed the parent trial following study protocol.
- Completed the parent study without receiving the full 3 rabies vaccine doses following the assigned pre-exposure prophylaxis regimen.
- History of exposure to suspected or confirmed rabid animal.
- Receipt of rabies immunoglobulins, rabies post exposure prophylaxis following completion of the parent study
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
To view plain language summaries on trialsummaries.com click here.