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

Document Type: Research Articles

Authors

1 National Committee of Adverse Event Following Immunization, MOH, Jakarta, Indonesia.

2 Ministry of Health, Indonesia National Committee on Adverse Event Following Immunization, Jakarta, Indonesia.

3 Head of Indonesian Society of Gynecologic Oncology (INASGO) and Head of Indonesian Working Group on HPV, Jakarta, Indonesia.

4 Department of Child Health, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.

5 Indonesia Ministry of Health, Immunization Sub-Directorate at Directorate of Surveillance, Immunization and Health Quarantine, Jakarta, Indonesia.

Abstract

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

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