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Dose-range study of MF59-adjuvanted versus nonadjuvanted monovalent A/H1N1 pandemic influenza vaccine in six- to less than thirty-six-month-old children.
Pediatr Infect Dis J. 2012 Jul; 31(7):e92-8.PI

Abstract

BACKGROUND

The successful vaccination of children 6 to 36 months of age against 2009 A/H1N1 influenza was essential to help reduce the burden of pandemic disease in both the pediatric and adult populations.

OBJECTIVES

We compared the immunogenicity and safety of 4 alternative monovalent vaccine formulations to identify which provided optimal levels of seroprotection according to the US and European Union (EU) licensure criteria.

SUBJECTS AND METHODS

A total of 654 healthy subjects (6 to <36 months old) were given 2 vaccine doses 3 weeks apart. Participants were assigned to 1 of the 4 immunization groups, receiving MF59-adjuvanted (Novartis Vaccines, Marburg, Germany) vaccine either containing 3.75 μg or 7.5 μg of A/H1N1 California/7/2009 antigen, or nonadjuvanted vaccine containing 7.5 μg or 15 μg of antigen. Antibody titers were assessed by hemagglutination inhibition assay 3 weeks, 3 months and 1 year after immunization. Vaccine safety was monitored throughout the study.

RESULTS

After 1 dose, both adjuvanted formulations met the US and EU criteria for seroconversion; the 15 μg nonadjuvanted vaccine met the EU criterion for seroconversion alone. The US and EU criteria for seroprotection were only met by adjuvanted groups. MF59-adjuvanted formulations alone resulted in clinically significant persisting antibody titers after 12 months. All vaccines were well tolerated.

CONCLUSIONS

A single dose of MF59-adjuvanted vaccine containing 3.75 μg A/H1N1 antigen was highly immunogenic, met both the US and EU licensure criteria and was well tolerated. These data support the suitability of this monovalent vaccine formulation for pandemic use in children 6 to <36 months of age.

Authors+Show Affiliations

Kentucky Pediatric and Adult Research Inc, Bardstown, KY 40004, USA. sblock@pol.netNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

22481427

Citation

Block, Stan L., et al. "Dose-range Study of MF59-adjuvanted Versus Nonadjuvanted Monovalent A/H1N1 Pandemic Influenza Vaccine in Six- to Less Than Thirty-six-month-old Children." The Pediatric Infectious Disease Journal, vol. 31, no. 7, 2012, pp. e92-8.
Block SL, Ruiz-Palacios GM, Guerrero ML, et al. Dose-range study of MF59-adjuvanted versus nonadjuvanted monovalent A/H1N1 pandemic influenza vaccine in six- to less than thirty-six-month-old children. Pediatr Infect Dis J. 2012;31(7):e92-8.
Block, S. L., Ruiz-Palacios, G. M., Guerrero, M. L., Beygo, J., Sales, V., & Holmes, S. J. (2012). Dose-range study of MF59-adjuvanted versus nonadjuvanted monovalent A/H1N1 pandemic influenza vaccine in six- to less than thirty-six-month-old children. The Pediatric Infectious Disease Journal, 31(7), e92-8. https://doi.org/10.1097/INF.0b013e318257644f
Block SL, et al. Dose-range Study of MF59-adjuvanted Versus Nonadjuvanted Monovalent A/H1N1 Pandemic Influenza Vaccine in Six- to Less Than Thirty-six-month-old Children. Pediatr Infect Dis J. 2012;31(7):e92-8. PubMed PMID: 22481427.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Dose-range study of MF59-adjuvanted versus nonadjuvanted monovalent A/H1N1 pandemic influenza vaccine in six- to less than thirty-six-month-old children. AU - Block,Stan L, AU - Ruiz-Palacios,Guillermo M, AU - Guerrero,M Lourdes, AU - Beygo,Jenny, AU - Sales,Victor, AU - Holmes,Sandra J, PY - 2012/4/7/entrez PY - 2012/4/7/pubmed PY - 2012/10/4/medline SP - e92 EP - 8 JF - The Pediatric infectious disease journal JO - Pediatr Infect Dis J VL - 31 IS - 7 N2 - BACKGROUND: The successful vaccination of children 6 to 36 months of age against 2009 A/H1N1 influenza was essential to help reduce the burden of pandemic disease in both the pediatric and adult populations. OBJECTIVES: We compared the immunogenicity and safety of 4 alternative monovalent vaccine formulations to identify which provided optimal levels of seroprotection according to the US and European Union (EU) licensure criteria. SUBJECTS AND METHODS: A total of 654 healthy subjects (6 to <36 months old) were given 2 vaccine doses 3 weeks apart. Participants were assigned to 1 of the 4 immunization groups, receiving MF59-adjuvanted (Novartis Vaccines, Marburg, Germany) vaccine either containing 3.75 μg or 7.5 μg of A/H1N1 California/7/2009 antigen, or nonadjuvanted vaccine containing 7.5 μg or 15 μg of antigen. Antibody titers were assessed by hemagglutination inhibition assay 3 weeks, 3 months and 1 year after immunization. Vaccine safety was monitored throughout the study. RESULTS: After 1 dose, both adjuvanted formulations met the US and EU criteria for seroconversion; the 15 μg nonadjuvanted vaccine met the EU criterion for seroconversion alone. The US and EU criteria for seroprotection were only met by adjuvanted groups. MF59-adjuvanted formulations alone resulted in clinically significant persisting antibody titers after 12 months. All vaccines were well tolerated. CONCLUSIONS: A single dose of MF59-adjuvanted vaccine containing 3.75 μg A/H1N1 antigen was highly immunogenic, met both the US and EU licensure criteria and was well tolerated. These data support the suitability of this monovalent vaccine formulation for pandemic use in children 6 to <36 months of age. SN - 1532-0987 UR - https://www.unboundmedicine.com/medline/citation/22481427/Dose_range_study_of_MF59_adjuvanted_versus_nonadjuvanted_monovalent_A/H1N1_pandemic_influenza_vaccine_in_six__to_less_than_thirty_six_month_old_children_ L2 - https://doi.org/10.1097/INF.0b013e318257644f DB - PRIME DP - Unbound Medicine ER -