Safety and Immunogenicity of the Inactivated Rabies Vaccine RABIVAX-S Administered Intramuscularl… (NCT05937113) | Clinical Trial Compass
CompletedPhase 4
Safety and Immunogenicity of the Inactivated Rabies Vaccine RABIVAX-S Administered Intramuscularly and Intradermally
Vietnam220 participantsStarted 2020-06-13
Plain-language summary
Randomized, open-label, prospective, before-and-after comparison study in the same group.
Subjects suitable for the study will be randomly assigned at a ratio of 1:1 (block 4) to use the study vaccine by one of two routes of administration: Intramuscular or Intramuscular. Previously-unvaccinated subjects receive three injections of vaccine on day 0, 7 and 21-28. The aim of the study is to evaluate the safety and immunogenicity of the inactivated rabies vaccine RABIVAX-S administered intramuscularly and intradermally according to a 3-dose regimen in healthy volunteers.
Who can participate
Age range5 Years – 60 Years
SexALL
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Inclusion criteria
✓. Healthy volunteers aged 5-60 years at the time of study screening.
✓. Consent to participate in the study by signing the consent to participate in the study after being provided with complete information about the study. The participation of research subjects under the age of 18 years will be signed by the legal guardian.
✓. Research subjects with normal health are determined according to personal medical history, clinical examination and laboratory tests within the clinically acceptable normal range.
✓. Able to follow the research process as assessed by the researcher.
✓. Women of reproductive age who have been using effective contraception for at least 4 weeks prior to screening and are willing to continue contraception until at least 4 weeks after the last dose of the study vaccine together. Men participating in the study agreed not to conceive until at least 4 weeks after the last dose of the study vaccine.
Exclusion criteria
✕. Subject is participating in any other clinical trial.
✕. Research facility staff working directly in this study and their families and relatives. Family, relatives are defined as spouses, parents, children or siblings, whether adopted or legally adopted.
What they're measuring
1
Rate of Subjects Experiencing Solicited Local and Systemic Adverse Events (AE) after
Timeframe: Within 30 minutes of each vaccination
2
Rate of Subjects Experiencing Solicited Local and Systemic Adverse Events (AE)
Timeframe: within 7 days (day 1 to 7) of each vaccination and within 21 day after the first vaccination
3
Rate of Subjects Experiencing Unsolicited Adverse Events (AE)
Timeframe: during 21 days after the third vaccination
4
Rate of Subjects Experiencing Unsolicited Serious Adverse Events (SAE)
✕. History of previous rabies vaccination (pre- or post-exposure regimen)
✕. Have received rabies immunoglobulin (human/equine) in the past.
✕. Fever (temperature ≥37°C) or moderate or severe acute illness, or infection on the day of vaccination.
✕. History of systemic hypersensitivity reaction to any vaccine component or history of life-threatening reaction to an experimental vaccine or a vaccine containing any vaccine-like substance study.
✕. Have received any immunoglobulin, blood, or blood-based product therapy in the past 3 months, which may interfere with the assessment of immune response.
✕. Known seropositive status for HIV antibody, HCV antibody or hepatitis B surface antigen (HBsAg) (retest not required).