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Safety of the Inactivated Japanese Encephalitis Virus Vaccine IXIARO in Children: An Open-label, Randomized, Active-controlled, Phase 3 Study.
Pediatr Infect Dis J. 2017 Sep; 36(9):889-897.PI

Abstract

BACKGROUND

Japanese encephalitis remains a serious health concern in Asian countries and has sporadically affected pediatric travelers. In the present study, we monitored the safety profile of the Japanese encephalitis virus vaccine IXIARO (Valneva Austria GmbH, Vienna, Austria) in a pediatric population.

METHODS

We randomized 1869 children between 2 months and 17 years of age in an age-stratified manner to vaccination with IXIARO or one of the control vaccines, Prevnar (formerly Wyeth Pharmaceuticals Inc., now Pfizer Inc., Kent, United Kingdom) and HAVRIX 720 (GlaxoSmithKline Biologicals, Rixensart, Belgium). Adverse events (AEs) (unsolicited and solicited local and systemic AEs), serious AEs and medically attended AEs were assessed up to day 56 and month 7 after the first dose.

RESULTS

Incidences of AEs, serious AEs or medically attended AEs did not differ significantly between the groups in any age stratum. AEs were most frequent in children <1 year of age and decreased with age. AEs of special interest, predefined as AEs associated with potential hypersensitivity/allergy or neurologic disorders up to day 56, were reported in 4.6% (IXIARO) versus 6.3% (Prevnar) in the ≥2 months to <1 year age group and 3.4% (IXIARO) versus 3.3% (HAVRIX) in the ≥1 to <18 years age group. Fever, the most frequent systemic reaction in 23.7% of infants to 3.8% of adolescents, decreased with age and did not differ between groups.

CONCLUSIONS

The safety profile of IXIARO was comparable to the control vaccines in terms of overall AE rates, serious AEs and medically attended AEs.

Authors+Show Affiliations

From the *Valneva Austria GmbH, Vienna, Austria; †Department of Pediatrics, University of the Philippines, ‡Department of Health, Research Institute for Tropical Medicine, and §Section of Infectious and Tropical Diseases, Department of Pediatrics, Universtity of the Philippines, College of Medicine, Philippine General Hospital, Manila, Philippines; and ¶Department of Health, Research Institute for Tropical Medicine, Muntinlupa, Philippines.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

28441266

Citation

Dubischar, Katrin L., et al. "Safety of the Inactivated Japanese Encephalitis Virus Vaccine IXIARO in Children: an Open-label, Randomized, Active-controlled, Phase 3 Study." The Pediatric Infectious Disease Journal, vol. 36, no. 9, 2017, pp. 889-897.
Dubischar KL, Kadlecek V, Sablan B, et al. Safety of the Inactivated Japanese Encephalitis Virus Vaccine IXIARO in Children: An Open-label, Randomized, Active-controlled, Phase 3 Study. Pediatr Infect Dis J. 2017;36(9):889-897.
Dubischar, K. L., Kadlecek, V., Sablan, B., Borja-Tabora, C. F., Gatchalian, S., Eder-Lingelbach, S., Mueller, Z., & Westritschnig, K. (2017). Safety of the Inactivated Japanese Encephalitis Virus Vaccine IXIARO in Children: An Open-label, Randomized, Active-controlled, Phase 3 Study. The Pediatric Infectious Disease Journal, 36(9), 889-897. https://doi.org/10.1097/INF.0000000000001623
Dubischar KL, et al. Safety of the Inactivated Japanese Encephalitis Virus Vaccine IXIARO in Children: an Open-label, Randomized, Active-controlled, Phase 3 Study. Pediatr Infect Dis J. 2017;36(9):889-897. PubMed PMID: 28441266.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety of the Inactivated Japanese Encephalitis Virus Vaccine IXIARO in Children: An Open-label, Randomized, Active-controlled, Phase 3 Study. AU - Dubischar,Katrin L, AU - Kadlecek,Vera, AU - Sablan,Benjamin,Jr AU - Borja-Tabora,Charissa Fay, AU - Gatchalian,Salvacion, AU - Eder-Lingelbach,Susanne, AU - Mueller,Zsuzsanna, AU - Westritschnig,Kerstin, PY - 2017/4/26/pubmed PY - 2017/9/19/medline PY - 2017/4/26/entrez SP - 889 EP - 897 JF - The Pediatric infectious disease journal JO - Pediatr. Infect. Dis. J. VL - 36 IS - 9 N2 - BACKGROUND: Japanese encephalitis remains a serious health concern in Asian countries and has sporadically affected pediatric travelers. In the present study, we monitored the safety profile of the Japanese encephalitis virus vaccine IXIARO (Valneva Austria GmbH, Vienna, Austria) in a pediatric population. METHODS: We randomized 1869 children between 2 months and 17 years of age in an age-stratified manner to vaccination with IXIARO or one of the control vaccines, Prevnar (formerly Wyeth Pharmaceuticals Inc., now Pfizer Inc., Kent, United Kingdom) and HAVRIX 720 (GlaxoSmithKline Biologicals, Rixensart, Belgium). Adverse events (AEs) (unsolicited and solicited local and systemic AEs), serious AEs and medically attended AEs were assessed up to day 56 and month 7 after the first dose. RESULTS: Incidences of AEs, serious AEs or medically attended AEs did not differ significantly between the groups in any age stratum. AEs were most frequent in children <1 year of age and decreased with age. AEs of special interest, predefined as AEs associated with potential hypersensitivity/allergy or neurologic disorders up to day 56, were reported in 4.6% (IXIARO) versus 6.3% (Prevnar) in the ≥2 months to <1 year age group and 3.4% (IXIARO) versus 3.3% (HAVRIX) in the ≥1 to <18 years age group. Fever, the most frequent systemic reaction in 23.7% of infants to 3.8% of adolescents, decreased with age and did not differ between groups. CONCLUSIONS: The safety profile of IXIARO was comparable to the control vaccines in terms of overall AE rates, serious AEs and medically attended AEs. SN - 1532-0987 UR - https://www.unboundmedicine.com/medline/citation/28441266/full_citation L2 - http://dx.doi.org/10.1097/INF.0000000000001623 DB - PRIME DP - Unbound Medicine ER -