Post Marketing Surveillance Study of 2nd Dose Quadrivalent Human Papilloma Virus Vaccine in Elementary School Children in Jakarta, Indonesia: Safety Result and Implementation of School-Based HPV Immunization Program

Abstract

Objective: Quadrivalent human papillomavirus (QHPV) vaccine has been advised for routine vaccination of<br />pre-adolescent girls globally, and a two-dose QHPV vaccination schedule has been introduced in Indonesia to vaccinate<br />5th and 6th grade elementary school female students. This post-marketing surveillance study evaluated the possible adverse<br />events following immunization with the two-dose QHPV vaccine in Indonesia. Methods: Girls studying in grade 6<br />of five designated elementary schools in Jakarta, receiving their 2nd dose of QHPV vaccine and provided informed<br />consent (represented by their parents), were included in the study. Students who had received other immunizations<br />either simultaneously or day, after the immunization were recorded using a Children Symptom Dairy Card/Kartu Harian Anak Sekolah (KHAS/<br />Student Daily Card). Results: A total of 500 students from 20 schools were included. No serious adverse events were<br />reported during the study period. Fever (systemic reaction) of mild intensity was noted in 1.6 % (n=8) of participants,<br />which subsided after day 6. Local reactions such as pain, redness and swelling were noted in 59.6% (n=295), 23.6%<br />(n=118), and 17.2% (n=86) of participants, respectively. These resolved without any intervention in majority of the<br />cases after day 5. Conclusion: These results along with the safety data from the pre-licensure clinical trials confirm<br />the favorable safety profile of QHPV vaccine in pre-adolescent girls. The school-based two-dose QHPV immunization<br />program in Indonesia is a safe and effective strategy for optimizing HPV vaccine coverage among pre-adolescent girls.