Adverse events following immunization of combined diphtheria, whole-cell pertussis, tetanus, and hepatitis B (DPwT/HB) vaccine
Abstract
Background Combined vaccine of diphtheria, whole-cell pertussis,tetanus, and hepatitis B (DPwT/HB) will reduce the number of
injections to children and simplify the delivery logistics. The adverse
events following immunization (AEFI) of this vaccine have to be
concerned since the events may increase or decrease.
Objectives To evaluate AEFI of DPwT/HB vaccine in healthy in-
fants.
Methods A descriptive prospective study of AEFI of three doses
of DPwT/HB vaccine was performed on 74 healthy infants aged
two to six months at the Department of Child Health, Cipto
Mangunkusumo Hospital, from July 2000 to March 2001.
Results Out of 74 infants, 68 received two doses and 67 completed
the study with a total of 209 doses. Of 209 doses, adverse events
were reported following 126 doses (60.3%), consisted of systemic
(60.3%) and local reactions (9.5%). The three most frequent AEFI
iwere mild fever (44.5%), high fever (15.7%), irritability (31.5%).
Most AEFI were coincidental (51.1%), occurred after more than
72 hours (31.4%) and lasted less than 24 hours (17.7%). Sys-
temic reactions were mostly found in 4-month-old infants (33.3%),
while local reactions in 2-, 3-, and 5-month-old infants (25%),
respectively.
Conclusion Most AEFI were coincidental and resolved without
any complication
References
C, Hossain A, Tuwaijiri A, editors. Viral hepatitis.
Current status and issues. New York: Springer-Verlag;
1993. p. 59-137.
2. World Health Organization. Global perspectives on hepati-
tis. Newsletter of the International Task Force on Hepatitis
B Immunization and the Program for Appropriate Technol-
ogy in Health (PATH) 1993;4:1-8.
3. Decker MD, Edwards KM. Combination vaccines. In:
Plotkin SA, Orenstein WA, editors. Vaccines. 3 rd ed.
Philadelphia: Saunders; 1999. p. 508-30.
4. Poovorawan Y, Theamboonlers A, Sanpavat S, Pongpunlert
W, Chumdermpadetsuk S, Safary A, et al. Comparison
study of combined DTPw-HB vaccines and separate ad-
ministration of DTPw and HB vaccines in Thai children.
Asian Pac J Allergy Immunol 1999;17:113-20.
5. Aristegui J, Garrote E, Gonzalez A, Arrate JP, Perez A,
Vandepapeliere P. Immune response to a combined
hepatitis B, diphtheria, tetanus, and whole-cell
pertussis vaccine administered to infants at 2, 4, and 6
months of age. Vaccine 1997;15:7-9.
6. Usonis V, Bakasenas V, Taylor D, Vandepapeliere P.
Immunogenicity and reactogenicity of a combined
DTPw-hepatitis B vaccine in Lithuanian infants. Eur J
Pediatr 1996;155:189-93.
7. Papaevangelou G, Karvelis E, Alexiou D, Kiossoglou
K, Roumeliotou A, Safary A, et al. Evaluation of a
combined tetravalent diphtheria, tetanus, whole-cell
pertussis and hepatitis B candidate vaccine
administered to healthy infants according to a three-
dose vaccination schedule. Vaccine 1995;13:175-8.
8. Poovorawan Y. Experience of combined tetravalent
diphtheria, tetanus, whole-cell pertussis and hepatitis
B vaccine in Thailand. Southeast Asian J Trop Med
Public Health 1997;28:496-9.
9. Hadinegoro SRS. Vaksin kombinasi. In: Ranuh IGN,
Soeyitno H, Hadinegoro SRS, Kartasasmita C, editors.
Buku imunisasi di Indonesia. 1 st ed. Jakarta: Ikatan
Dokter Anak Indonesia; 2001. p. 147-56.
10. Pichichero ME. New combination vaccines. Pediatr
Clin North Am 2000;47:407-26.
11. World Health Organization. Immunization Safety
Surveillance. Geneva: WHO; 1999.
12. Komite Nasional Pengkajian & Penanggulangan
Kejadian Ikutan Pasca Imunisasi. Pedoman tatalaksana
medik kejadian ikutan pasca imunisasi bagi petugas
kesehatan. 4 th ed. Jakarta: KN PP KIPI; 2002.
13. Akib AAP. Kejadian ikutan pasca-imunisasi. In: Trihono PP,
Pudjiarto PS, Syarif DR, Hegar B, Gunardi H, Oswari H,
dkk, editors. Hot topics in pediatrics II. Proceedings of the
45 th Pediatrics Continuing Medical Education, Medical
School, University of Indonesia; 2002 Feb 18-19; Jakarta,
Indonesia. Jakarta: Balai Penerbit FKUI; 2002. p. 302-11.
14. Chen RT. Safety of vaccines. In: Plotkin SA, Orenstein
WA, editors. Vaccines. 3 rd ed. Philadelphia: Saunders;
1999. p. 1144-63.
15. Sundoro J. Respons antibodi dan kejadian ikutan
pascaimunisasi pada bayi sehat yang diimunisasi DPT/
HB kombinasi dibandingkan dengan DPT+HB terpisah
di Kabupaten Bogor, Jawa Barat, tahun 2001-2002 [dis-
sertation]. Jakarta: University of Indonesia; 2003.
16. Advisory Committee on Immunization Practices. Update:
vaccine side effects, adverse reactions, contraindications,
and precautions. Recommendation of the Advisory Com-
mittee on Immunization Practices (ACIP). MMWR
1996;45:1-33.
17. Soetomenggolo TS. Kejang demam. In: Soetomenggolo
TS, Ismael S, editors. Buku ajar neurologi anak. 1 st
ed. Jakarta: Ikatan Dokter Anak Indonesia; 1999. p.
244-52.
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Accepted 2016-10-03
Published 2016-10-10