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Immunogenicity, safety, and interchangeability of two inactivated hepatitis A vaccines in Chilean children.
Int J Infect Dis. 2008 May; 12(3):270-7.IJ

Abstract

OBJECTIVES

To compare the immunogenicity, safety, and interchangeability of two pediatric hepatitis A vaccines, Avaxim 80U-Pediatric and Havrix 720, in Chilean children.

METHODS

In this randomized trial, 332 hepatitis A virus (HAV) seronegative children from 1 to 15 years of age received two doses of Avaxim, two doses of Havrix, or Havrix followed by Avaxim, 6 months apart. Anti-HAV antibody titers were measured before and 14 days after the first dose of vaccine, and before and 28 days after the second dose of vaccine. Immediate reactions were monitored; reactogenicity was evaluated from parental reports.

RESULTS

Seroconversion rates after the first vaccination were 99.4% and 100% for Avaxim and Havrix, respectively. Anti-HAV geometric mean concentrations (GMCs) were 138 mIU/ml for Havrix (95% confidence interval (CI): 120; 159) and 311 mIU/ml for Avaxim (95% CI: 274; 353). GMCs increased to 4008 mIU/ml after two doses of Havrix, 8537 mIU/ml following two doses of Avaxim, and 7144 mIU/ml in children who received Havrix with Avaxim as the second dose. Following the first injection, 36% of subjects given Avaxim and 44% given Havrix reported local reactions; 38% of subjects in the Avaxim group and 40% in the Havrix group reported systemic reactions related to vaccination. Solicited reactions were less frequent after the second dose of Avaxim or Havrix, occurring in 27% to 37% of subjects.

CONCLUSIONS

No significant difference in seroconversion rates was seen 14 days after a single dose of vaccine. A two-dose schedule with either vaccine or with Havrix/Avaxim provided a strong booster response. Both vaccines were well tolerated and can be recommended for routine vaccination of Chilean children. Avaxim 80 may be used to complete a vaccine schedule begun with Havrix 720.

Authors+Show Affiliations

Centro Médico San Joaquín, Pontificia Universidad Católica de Chile, Marcoleta 391, Santiago, Chile. katia@med.puc.clNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17988917

Citation

Abarca, Katia, et al. "Immunogenicity, Safety, and Interchangeability of Two Inactivated Hepatitis a Vaccines in Chilean Children." International Journal of Infectious Diseases : IJID : Official Publication of the International Society for Infectious Diseases, vol. 12, no. 3, 2008, pp. 270-7.
Abarca K, Ibánez I, Perret C, et al. Immunogenicity, safety, and interchangeability of two inactivated hepatitis A vaccines in Chilean children. Int J Infect Dis. 2008;12(3):270-7.
Abarca, K., Ibánez, I., Perret, C., Vial, P., & Zinsou, J. A. (2008). Immunogenicity, safety, and interchangeability of two inactivated hepatitis A vaccines in Chilean children. International Journal of Infectious Diseases : IJID : Official Publication of the International Society for Infectious Diseases, 12(3), 270-7.
Abarca K, et al. Immunogenicity, Safety, and Interchangeability of Two Inactivated Hepatitis a Vaccines in Chilean Children. Int J Infect Dis. 2008;12(3):270-7. PubMed PMID: 17988917.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Immunogenicity, safety, and interchangeability of two inactivated hepatitis A vaccines in Chilean children. AU - Abarca,Katia, AU - Ibánez,Isabel, AU - Perret,Cecilia, AU - Vial,Pablo, AU - Zinsou,Jean-Antoine, Y1 - 2007/11/07/ PY - 2007/02/07/received PY - 2007/08/12/revised PY - 2007/08/22/accepted PY - 2007/11/9/pubmed PY - 2008/7/24/medline PY - 2007/11/9/entrez SP - 270 EP - 7 JF - International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases JO - Int J Infect Dis VL - 12 IS - 3 N2 - OBJECTIVES: To compare the immunogenicity, safety, and interchangeability of two pediatric hepatitis A vaccines, Avaxim 80U-Pediatric and Havrix 720, in Chilean children. METHODS: In this randomized trial, 332 hepatitis A virus (HAV) seronegative children from 1 to 15 years of age received two doses of Avaxim, two doses of Havrix, or Havrix followed by Avaxim, 6 months apart. Anti-HAV antibody titers were measured before and 14 days after the first dose of vaccine, and before and 28 days after the second dose of vaccine. Immediate reactions were monitored; reactogenicity was evaluated from parental reports. RESULTS: Seroconversion rates after the first vaccination were 99.4% and 100% for Avaxim and Havrix, respectively. Anti-HAV geometric mean concentrations (GMCs) were 138 mIU/ml for Havrix (95% confidence interval (CI): 120; 159) and 311 mIU/ml for Avaxim (95% CI: 274; 353). GMCs increased to 4008 mIU/ml after two doses of Havrix, 8537 mIU/ml following two doses of Avaxim, and 7144 mIU/ml in children who received Havrix with Avaxim as the second dose. Following the first injection, 36% of subjects given Avaxim and 44% given Havrix reported local reactions; 38% of subjects in the Avaxim group and 40% in the Havrix group reported systemic reactions related to vaccination. Solicited reactions were less frequent after the second dose of Avaxim or Havrix, occurring in 27% to 37% of subjects. CONCLUSIONS: No significant difference in seroconversion rates was seen 14 days after a single dose of vaccine. A two-dose schedule with either vaccine or with Havrix/Avaxim provided a strong booster response. Both vaccines were well tolerated and can be recommended for routine vaccination of Chilean children. Avaxim 80 may be used to complete a vaccine schedule begun with Havrix 720. SN - 1201-9712 UR - https://www.unboundmedicine.com/medline/citation/17988917/Immunogenicity_safety_and_interchangeability_of_two_inactivated_hepatitis_A_vaccines_in_Chilean_children_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1201-9712(07)00161-0 DB - PRIME DP - Unbound Medicine ER -