Clinical Trials - India: See Table 1.
Clinical Trials - Global: See Table 2.
Intramuscular Route of Administration: Pre-exposure Prophylaxis (M49P2): See Figure 2 and Table 3.
Post-exposure Prophylaxis (V49_25): See Figure 3 and Table 4.
Post-exposure Prophylaxis (V49_24): See Figure 4 and Table 5.
Post-exposure Prophylaxis (M49P1): See Figure 5 and Table 6.
Intradermal Route of Administration: Pre-exposure Prophylaxis (M49P2): See Figure 6 and Table 7.
Post-exposure Prophylaxis (M49P3): See Figure 7 and Table 8.
Special Populations: Post-exposure Prophylaxis in Pregnant Women: Essen regimen (1-1-1-1-1) was used for the subjects involved, one dose was administered at Days 0, 3, 7, 14, and 28.
ChiroRab is safe for pregnant women and did not interfere with the development of the fetuses or infants.
All of the infants exhibited normal development.
No miscarriages, stillbirths, or fetal malformations were reported.
No rabies cases were reported for any of the subjects or babies.
Immunogenicity of ChiroRab in Immunocompromised Individuals: See Figure 8 and Table 9.
Post-exposure Prophylaxis in Malnourished Children: See Figure 9 and Table 10.
Efficacy of ChiroRab: Phase IV study to evaluate the efficacy in terms of 1 year survival with ChiroRab administered intradermally in subjects exposed to laboratory confirmed rabid animals has shown that 12 months after exposure, all 113 patients were alive and no patient had succumbed to rabies or died of other causes.
Safety of ChiroRab: ChiroRab has an excellent safety and tolerability profile. Safety of ChiroRab has been established in more than 20 clinical trials worldwide in both children, adults and post-marketing reports.
In clinical trials, ChiroRab has been associated with local reactions, such as injection site pain (30-85%) and induration (15-35%).
Most of the side-effects in clinical studies were minor, self-limiting and required no treatment.
ChiroRab is safe to administer in pregnant and immunocompromised individuals.
Adverse reactions observed in clincal trials and during the post-marketing period: Very common (>1/10): Injection site reaction, Injection site swelling.
Common (>1/100, <1/10): Injection site erythema, Fatigue, Pyrexia, Headache, Myalgia, Gastrointestinal disorders.
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