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Influenza A/H1N1 MF59-adjuvanted vaccine in preterm and term children aged 6 to 23 months.
Pediatrics. 2011 May; 127(5):e1161-8.Ped

Abstract

OBJECTIVE

This study was designed to evaluate the immunogenicity, safety, and tolerability of a monovalent 2009 pandemic influenza A/H1N1 MF59-adjuvanted vaccine in children aged 6 to 23 months who had different gestational ages (GAs) at birth.

METHODS

The study involved 105 children: 35 preterm subjects with a GA of <32 weeks; 35 preterm subjects with a GA of 32 to 36 weeks; and 35 term subjects with a GA of 37 to 42 weeks. Each child received 2 intramuscular vaccine doses (Focetria [Novartis, Siena, Italy]): dose 1 at enrollment and dose 2 after 4 weeks (28 ± 2 days). Serum samples for antibody measurements were collected immediately before administration of dose 1, before administration of dose 2 (28 ± 2 days after baseline), and 4 weeks later (56 ± 2 days after baseline). Local and systemic reactions were assessed during the 14 days after each vaccination.

RESULTS

Of the 101 children who completed the study 32 out of 34 preterm subjects with a GA of <32 weeks, all of the preterm subjects with a GA of 32 to 36 weeks, and all of the term subjects seroconverted and were seroprotected after the first vaccine dose. Local and systemic tolerability was good in all of the groups, but fever was significantly more common after the first dose than after the second dose (P < .05), and there were no between-group differences.

CONCLUSIONS

A single dose of 2009 pandemic influenza A/H1N1 MF59-adjuvanted vaccine evoked a significant immune response against pandemic influenza A/H1N1 virus in children aged 6 to 23 months even if their GA was <32 weeks. The vaccine had a good safety and tolerability profile.

Authors+Show Affiliations

Department of Maternal and Pediatric Sciences, Università degli Studi di Milano, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Via Commenda 9, 20122 Milano, Italy.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)

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

Language

eng

PubMed ID

21464195

Citation

Esposito, Susanna, et al. "Influenza A/H1N1 MF59-adjuvanted Vaccine in Preterm and Term Children Aged 6 to 23 Months." Pediatrics, vol. 127, no. 5, 2011, pp. e1161-8.
Esposito S, Pugni L, Daleno C, et al. Influenza A/H1N1 MF59-adjuvanted vaccine in preterm and term children aged 6 to 23 months. Pediatrics. 2011;127(5):e1161-8.
Esposito, S., Pugni, L., Daleno, C., Ronchi, A., Valzano, A., Serra, D., Mosca, F., & Principi, N. (2011). Influenza A/H1N1 MF59-adjuvanted vaccine in preterm and term children aged 6 to 23 months. Pediatrics, 127(5), e1161-8. https://doi.org/10.1542/peds.2010-1920
Esposito S, et al. Influenza A/H1N1 MF59-adjuvanted Vaccine in Preterm and Term Children Aged 6 to 23 Months. Pediatrics. 2011;127(5):e1161-8. PubMed PMID: 21464195.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Influenza A/H1N1 MF59-adjuvanted vaccine in preterm and term children aged 6 to 23 months. AU - Esposito,Susanna, AU - Pugni,Lorenza, AU - Daleno,Cristina, AU - Ronchi,Andrea, AU - Valzano,Antonia, AU - Serra,Domenico, AU - Mosca,Fabio, AU - Principi,Nicola, Y1 - 2011/04/04/ PY - 2011/4/6/entrez PY - 2011/4/6/pubmed PY - 2011/7/12/medline SP - e1161 EP - 8 JF - Pediatrics JO - Pediatrics VL - 127 IS - 5 N2 - OBJECTIVE: This study was designed to evaluate the immunogenicity, safety, and tolerability of a monovalent 2009 pandemic influenza A/H1N1 MF59-adjuvanted vaccine in children aged 6 to 23 months who had different gestational ages (GAs) at birth. METHODS: The study involved 105 children: 35 preterm subjects with a GA of <32 weeks; 35 preterm subjects with a GA of 32 to 36 weeks; and 35 term subjects with a GA of 37 to 42 weeks. Each child received 2 intramuscular vaccine doses (Focetria [Novartis, Siena, Italy]): dose 1 at enrollment and dose 2 after 4 weeks (28 ± 2 days). Serum samples for antibody measurements were collected immediately before administration of dose 1, before administration of dose 2 (28 ± 2 days after baseline), and 4 weeks later (56 ± 2 days after baseline). Local and systemic reactions were assessed during the 14 days after each vaccination. RESULTS: Of the 101 children who completed the study 32 out of 34 preterm subjects with a GA of <32 weeks, all of the preterm subjects with a GA of 32 to 36 weeks, and all of the term subjects seroconverted and were seroprotected after the first vaccine dose. Local and systemic tolerability was good in all of the groups, but fever was significantly more common after the first dose than after the second dose (P < .05), and there were no between-group differences. CONCLUSIONS: A single dose of 2009 pandemic influenza A/H1N1 MF59-adjuvanted vaccine evoked a significant immune response against pandemic influenza A/H1N1 virus in children aged 6 to 23 months even if their GA was <32 weeks. The vaccine had a good safety and tolerability profile. SN - 1098-4275 UR - https://www.unboundmedicine.com/medline/citation/21464195/Influenza_A/H1N1_MF59_adjuvanted_vaccine_in_preterm_and_term_children_aged_6_to_23_months_ L2 - http://pediatrics.aappublications.org/cgi/pmidlookup?view=long&amp;pmid=21464195 DB - PRIME DP - Unbound Medicine ER -