Short-term safety of live attenuated Japanese encephalitis vaccine (SA14-14-2)

Results of a randomized trial with 26,239 subjects

Zheng Le Liu, Sean Hennessy, Brian Strom, Theodore F. Tsai, Chao Min Wan, Sheng Cai Tang, Cheng Fa Xiang, Warren B. Bilker, Xiao Ping Pan, Yu Jia Yao, Zheng Wei Xu, Scott B. Halstead

Research output: Contribution to journalArticle

82 Citations (Scopus)

Abstract

The short-term safety of an effective and inexpensive new live attenuated Japanese encephalitis vaccine (SA14-14-2) was studied in a randomized trial, using block randomization. Of 26,239 children who were enrolled, half received the vaccine and half served as controls. Subjects were prospectively followed for 30 days for severe adverse events, such as encephalitis, meningitis, and 'all-cause' hospitalization. No cases of encephalitis or meningitis occurred in either group. The upper 95% confidence limit for adverse events not occurring among subjects receiving their first dose was 4.1/10,000. Risk ratios and 95% confidence intervals for other adverse events were 0.70 (0.43-1.15) for all-cause hospitalization, 0.91 (0.37-2.22) for seizure, and 0.79 (0.56-1.11) for fever lasting ≤3 days. These data attest to the short-term safety of the SA14-14-2 virus strain and the hamster kidney cell substrate.

Original languageEnglish (US)
Pages (from-to)1366-1369
Number of pages4
JournalJournal of Infectious Diseases
Volume176
Issue number5
DOIs
StatePublished - Jan 1 1997
Externally publishedYes

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Japanese Encephalitis Vaccines
Attenuated Vaccines
Encephalitis
Meningitis
Hospitalization
Safety
Random Allocation
Cricetinae
Seizures
Fever
Vaccines
Odds Ratio
Confidence Intervals
Viruses
Kidney

All Science Journal Classification (ASJC) codes

  • Immunology and Allergy
  • Infectious Diseases

Cite this

Liu, Zheng Le ; Hennessy, Sean ; Strom, Brian ; Tsai, Theodore F. ; Wan, Chao Min ; Tang, Sheng Cai ; Xiang, Cheng Fa ; Bilker, Warren B. ; Pan, Xiao Ping ; Yao, Yu Jia ; Xu, Zheng Wei ; Halstead, Scott B. / Short-term safety of live attenuated Japanese encephalitis vaccine (SA14-14-2) : Results of a randomized trial with 26,239 subjects. In: Journal of Infectious Diseases. 1997 ; Vol. 176, No. 5. pp. 1366-1369.
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author = "Liu, {Zheng Le} and Sean Hennessy and Brian Strom and Tsai, {Theodore F.} and Wan, {Chao Min} and Tang, {Sheng Cai} and Xiang, {Cheng Fa} and Bilker, {Warren B.} and Pan, {Xiao Ping} and Yao, {Yu Jia} and Xu, {Zheng Wei} and Halstead, {Scott B.}",
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Liu, ZL, Hennessy, S, Strom, B, Tsai, TF, Wan, CM, Tang, SC, Xiang, CF, Bilker, WB, Pan, XP, Yao, YJ, Xu, ZW & Halstead, SB 1997, 'Short-term safety of live attenuated Japanese encephalitis vaccine (SA14-14-2): Results of a randomized trial with 26,239 subjects', Journal of Infectious Diseases, vol. 176, no. 5, pp. 1366-1369. https://doi.org/10.1086/517323

Short-term safety of live attenuated Japanese encephalitis vaccine (SA14-14-2) : Results of a randomized trial with 26,239 subjects. / Liu, Zheng Le; Hennessy, Sean; Strom, Brian; Tsai, Theodore F.; Wan, Chao Min; Tang, Sheng Cai; Xiang, Cheng Fa; Bilker, Warren B.; Pan, Xiao Ping; Yao, Yu Jia; Xu, Zheng Wei; Halstead, Scott B.

In: Journal of Infectious Diseases, Vol. 176, No. 5, 01.01.1997, p. 1366-1369.

Research output: Contribution to journalArticle

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AU - Bilker, Warren B.

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AU - Yao, Yu Jia

AU - Xu, Zheng Wei

AU - Halstead, Scott B.

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