COMPARISON OF POST-LICENSURE SAFETY SURVEILLANCE OF BIVALENT AND QUADRIVALENT HUMAN PAPILLOMAVIRUS VACCINES IN HEALTHY MUMBAI WOMEN

摘要

Objective: This study is the first comprehensive effort after HPV vaccine controversy in INDIA to compare two HPV vaccines without vaccine manufacturers funding in single, randomized, well-defined population of healthy married women aged 18-25 years using identical methodology for assessment. Methods: The study protocol was approved by an institutional ethical review committee and registered in Clinical trial registry of INDIA prior to subject recruitment. Total 77 women were screened but 69 were randomized to receive either HPV2 or HPV4 vaccines. Results: According to the present study, both HPV vaccines were well tolerated without any serious vaccine-related adverse event. Adverse drug reactions reported for both HPV vaccinations were 22 (35.48%) after the ?rst dose, 7 (12.05%) after the second dose and 11 (25%) after the third dose. After bivalent and quadrivalent HPV vaccination, 29 and 11 adverse drug events were recorded within seven days after any HPV vaccine dose respectively. Most frequently reported solicited local symptom from both groups was34 injection site pain which was mild in intensity. Conclusion: Both HPV vaccines appear to be safe, HPV4 being more cost-effective. However, large scale post-marketing studies are needed in view of amount of disease burden. Keywords: HPV2, HPV4, Safety, Adverse drug reactions (ADRs), Injection-site pain, India.