Immunogenicity and safety of AS03-adjuvanted H1N1 pandemic vaccines in children and adolescents

García-Sicilia, José; Gillard, Paul; Carmona, Alfonso; Tejedor, Juan Carlos; Arı́stegui, Javier; Merino, José; Behre, Ulrich; Caplanusi, Adrian; Vaman, Tejaswini; Dieussaert, Ilse

doi:10.1016/j.vaccine.2011.04.011

Cited by 33 publications

(23 citation statements)

References 27 publications

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“…In our study, seroprotection and seroconversion rates of 100% against 2009 pandemic influenza were observed at 1, 2, and 3 months after vaccination, regardless of the dose employed. Our results confirm the high immunogenic response to one dose of the 2009 pandemic influenza adjuvanted vaccine reported in studies of healthy children and adolescents as well as HIV-infected children and adults (11,13,17).…”

Section: Discussionsupporting

confidence: 89%

“…The immunogenicity of two doses of AS03-adjuvanted 2009 pandemic influenza vaccine (3.75 g of HA versus 1.9 g of HA) was evaluated for children aged 3 to 17 years in a recent study (13). In this study, a single dose of 3.75 g of HA plus AS03 A adjuvant was as effective as a single dose of 1.9 g of HA plus AS03 B adjuvant to satisfy the targets specified by the EMA Committee for Medical Products for Human Use.…”

Section: Discussionmentioning

confidence: 99%

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Long-Term Immunogenicity after One and Two Doses of a Monovalent MF59-Adjuvanted A/H1N1 Influenza Virus Vaccine Coadministered with the Seasonal 2009-2010 Nonadjuvanted Influenza Virus Vaccine in HIV-Infected Children, Adolescents, and Young Adults in a Randomized Controlled Trial

Viganò

Giacomet

Pariani

et al. 2011

Clin. Vaccine Immunol.

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Few data are available on the safety and long-term immunogenicity of A/H1N1 pandemic influenza vaccines for HIV-infected pediatric patients. We performed a randomized controlled trial to evaluate the safety and long-term immunogenicity of 1 versus 2 doses of the 2009 monovalent pandemic influenza A/H1N1 MF59-adjuvanted vaccine (PV) coadministered with the seasonal 2009-2010 trivalent nonadjuvanted influenza vaccine (SV) to HIV-infected children, adolescents, and young adults. A total of 66 HIV-infected patients aged 9 to 26 years were randomized to receive one (group 1) or two (group 2) doses of PV coadministered with 1 dose of SV. The main outcome was the seroconversion rate for PV at 1 month. Secondary outcomes were the geometric mean titer ratios and the seroprotection rates at 1 month for all vaccines, seroconversion rates at 1 month for SV, and longitudinal changes of antibody titers (ABTs) at 1, 2, 6, and 12 months for all vaccines. Groups 1 and 2 had similar CD4 counts and HIV RNA levels during the study. The seroconversion rate for PV was 100% at 1 month in both groups. ABTs for PV were high during the first 6 months and declined below seroprotection levels thereafter. Longitudinal changes in ABTs were similar in groups 1 and 2 for both PV and SV. The side effects of vaccination were mild and mostly local. In HIV-infected children, adolescents, and young adults, the immune response triggered by a single dose of PV was similar to that obtained with a double dose and was associated with long-term antibody response.

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Section: Discussionsupporting

confidence: 89%

Section: Discussionmentioning

confidence: 99%

Long-Term Immunogenicity after One and Two Doses of a Monovalent MF59-Adjuvanted A/H1N1 Influenza Virus Vaccine Coadministered with the Seasonal 2009-2010 Nonadjuvanted Influenza Virus Vaccine in HIV-Infected Children, Adolescents, and Young Adults in a Randomized Controlled Trial

Viganò

Giacomet

Pariani

et al. 2011

Clin. Vaccine Immunol.

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“…Findings of this study are in agreement with previously published results of MF59-adjuvanted A/H1N1 vaccine in adults and children [17,[27][28][29][30]. Similar results were also reported in paediatric and adult populations using the AS03 ® -adjuvanted H1N1 pandemic vaccine (GlaxoSmithKline Biologicals, Wavre, Belgium) [31,32], providing further proof of the benefits of adjuvanted A/H1N1 vaccines. Results are presented for individual subjects.…”

Section: Discussionsupporting

confidence: 92%

Safety and immunogenicity of an MF59®-adjuvanted A/H1N1 pandemic influenza vaccine in children from three to seventeen years of age

Knuf¹,

Leroux‐Roels²,

Rümke³

et al. 2015

Vaccine

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a b s t r a c tObjectives: This study was designed to identify the optimal dose of an MF59® -adjuvanted, monovalent, A/H1N1 influenza vaccine in healthy paediatric subjects. Methods: Subjects aged 3-8 years (n = 194) and 9-17 years (n = 160) were randomized to receive two primary doses of A/H1N1 vaccine containing either 3.75 g antigen with half a standard dose of MF59 adjuvant, 7.5 g antigen with a full dose of MF59, or (children 3-8 years only), a non-adjuvanted 15 g formulation. A booster dose of MF59-adjuvanted seasonal influenza vaccine including homologous A/H1N1 strain was given one year after priming. Immunogenicity was assessed by haemagglutination inhibition (HI) and microneutralization assays. Vaccine safety was assessed throughout the study (up to 18 months). Results: A single priming dose of either MF59-adjuvanted formulation was sufficient to meet the European licensure criteria for pandemic influenza vaccines (HI titres ≥1:40 > 70%; seroconversion > 40%; and GMR > 2.5). Two non-adjuvanted vaccine doses were required to meet the same licensure criteria. After first and second doses, percentage of subjects with HI titres ≥1:40 were between 97% and 100% in the adjuvanted vaccine groups compared with 68% and 91% in the non-adjuvanted group, respectively. Postvaccination seroconversion rates ranged from 91% to 98% in adjuvanted groups and were 68% (first dose) and 98% (second dose) in the non-adjuvanted group. HI titres ≥1:330 after primary doses were achieved in 69% to 90% in adjuvanted groups compared with 41% in the non-adjuvanted group. Long-term antibody persistence after priming and a robust antibody response to booster immunization were observed in all vaccination groups. All A/H1N1 vaccine formulations were generally well tolerated. No vaccine-related serious adverse events occurred, and no subjects were withdrawn from the study due to an adverse event.Conclusions: An MF59-adjuvanted influenza vaccine containing 3.75 g of A/H1N1 antigen was well tolerated and sufficiently immunogenic to meet all the European licensure criteria after a single dose in healthy children 3-17 years old.

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“…The level of dose-sparing achieved in this study with AF03 adjuvanted vaccine appeared similar to that of an AS03 adjuvanted vaccine used in pediatric populations, with an antigen dose as low as 3.75 μg in children from 3 y of age and 1.9 μg in children less than 3 y inducing seroconversion in more than 95% of the children after first vaccination. 24,25 The…”

Section: Discussionmentioning

confidence: 99%

Assessment of squalene adjuvanted and non-adjuvanted vaccines against pandemic H1N1 influenza in children 6 months to 17 years of age

Vesikari¹,

Pépin²,

Kusters³

et al. 2012

Human Vaccines & Immunotherapeutics

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Immunogenicity and safety of AS03-adjuvanted H1N1 pandemic vaccines in children and adolescents

Cited by 33 publications

References 27 publications

Long-Term Immunogenicity after One and Two Doses of a Monovalent MF59-Adjuvanted A/H1N1 Influenza Virus Vaccine Coadministered with the Seasonal 2009-2010 Nonadjuvanted Influenza Virus Vaccine in HIV-Infected Children, Adolescents, and Young Adults in a Randomized Controlled Trial

Long-Term Immunogenicity after One and Two Doses of a Monovalent MF59-Adjuvanted A/H1N1 Influenza Virus Vaccine Coadministered with the Seasonal 2009-2010 Nonadjuvanted Influenza Virus Vaccine in HIV-Infected Children, Adolescents, and Young Adults in a Randomized Controlled Trial

Safety and immunogenicity of an MF59®-adjuvanted A/H1N1 pandemic influenza vaccine in children from three to seventeen years of age

Assessment of squalene adjuvanted and non-adjuvanted vaccines against pandemic H1N1 influenza in children 6 months to 17 years of age

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