Medical Journal of Indonesia Vol. 31 No. 4 2022 FKUI
Safety of A 2-Dose Primary Series of 13-Valent Pneumococcal Conjugate Vaccine in Indonesian Infants
Dublin Core
Title
Medical Journal of Indonesia Vol. 31 No. 4 2022 FKUI
Safety of A 2-Dose Primary Series of 13-Valent Pneumococcal Conjugate Vaccine in Indonesian Infants
Safety of A 2-Dose Primary Series of 13-Valent Pneumococcal Conjugate Vaccine in Indonesian Infants
Subject
adverse effects, conjugate vaccine, Indonesia, infant, pneumococcal
vaccines, safety
vaccines, safety
Description
BACKGROUND In 2017, the Indonesian Technical Advisory Group on Immunization
recommended a safety monitoring demonstration program for the 13-valent
pneumococcal conjugate vaccine (PCV13) in West Lombok and East Lombok, West
Nusa Tenggara to evaluate the 2-dose primary series (2 and 3 months of age) for serious
adverse events (SAEs), adverse events, systemic events, and local reactions.
METHODS A total of 1,083 infants from 10 primary healthcare centers were analyzed,
with 687 receiving the first dose and 396 receiving the second dose. Based on the
national immunization program, they received PCV13 + DTwP-HB-Hib + OPV (n = 544),
PCV13 + DTwP-HB-Hib (n = 101), or PCV13 only (n = 403). They were monitored for 30 min
after vaccination for any immediate SAEs, and parents were given a diary card to record
safety information prospectively for 28 days.
RESULTS No immediate SAEs were observed, and no SAEs were reported during 28
days after vaccination. Reports of local reactions and systemic events predominated on
days 1–3 post-vaccination. Severe fever (axillary temperature >39.0°C) was uncommon
(<2% of all infants). Most irritability was mild to moderate. Local pain was more frequent
after the first dose than after the second dose. It was distributed evenly across mild,
moderate, and severe classifications, while redness and swelling were mostly mild to
moderate.
CONCLUSIONS The PCV13 primary series demonstration program in Indonesia
confirmed tolerable local and systemic reactions.
recommended a safety monitoring demonstration program for the 13-valent
pneumococcal conjugate vaccine (PCV13) in West Lombok and East Lombok, West
Nusa Tenggara to evaluate the 2-dose primary series (2 and 3 months of age) for serious
adverse events (SAEs), adverse events, systemic events, and local reactions.
METHODS A total of 1,083 infants from 10 primary healthcare centers were analyzed,
with 687 receiving the first dose and 396 receiving the second dose. Based on the
national immunization program, they received PCV13 + DTwP-HB-Hib + OPV (n = 544),
PCV13 + DTwP-HB-Hib (n = 101), or PCV13 only (n = 403). They were monitored for 30 min
after vaccination for any immediate SAEs, and parents were given a diary card to record
safety information prospectively for 28 days.
RESULTS No immediate SAEs were observed, and no SAEs were reported during 28
days after vaccination. Reports of local reactions and systemic events predominated on
days 1–3 post-vaccination. Severe fever (axillary temperature >39.0°C) was uncommon
(<2% of all infants). Most irritability was mild to moderate. Local pain was more frequent
after the first dose than after the second dose. It was distributed evenly across mild,
moderate, and severe classifications, while redness and swelling were mostly mild to
moderate.
CONCLUSIONS The PCV13 primary series demonstration program in Indonesia
confirmed tolerable local and systemic reactions.
Creator
Julitasari Sundoro, Ari Prayitno, Hindra Irawan Satari, I Gusti Gede Djelantik, Mark Andrew Fletcher, Sri Rezeki, Hadinegoro, Syafriyal
Date
February 12, 2023
Contributor
peri irawan
Format
pdf
Language
english
Type
text
Files
Citation
Julitasari Sundoro, Ari Prayitno, Hindra Irawan Satari, I Gusti Gede Djelantik, Mark Andrew Fletcher, Sri Rezeki, Hadinegoro, Syafriyal, “Medical Journal of Indonesia Vol. 31 No. 4 2022 FKUI
Safety of A 2-Dose Primary Series of 13-Valent Pneumococcal Conjugate Vaccine in Indonesian Infants,” Repository Horizon University Indonesia, accessed September 20, 2024, https://repository.horizon.ac.id/items/show/1094.
Safety of A 2-Dose Primary Series of 13-Valent Pneumococcal Conjugate Vaccine in Indonesian Infants,” Repository Horizon University Indonesia, accessed September 20, 2024, https://repository.horizon.ac.id/items/show/1094.