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Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine in Children 6 Months to 17 Years of Age, Previously Vaccinated with an AS03-Adjuvanted A(H1N1)Pdm09 Vaccine: Two Open-label, Randomized Trials.
Pediatr Infect Dis J 2015; 34(7):774-82PI

Abstract

BACKGROUND

During the influenza pandemic 2009-2010, an AS03-adjuvanted A(H1N1)pdm09 vaccine was used extensively in children 6 months of age and older, and during the 2010-2011 influenza season, the A(H1N1)pdm09 strain was included in the seasonal trivalent inactivated influenza vaccine (TIV) without adjuvant. We evaluated the immunogenicity and safety of TIV in children previously vaccinated with the AS03-adjuvanted A(H1N1)pdm09 vaccine.

METHODS

Healthy children were randomized (1:1) to receive TIV or a control vaccine. Children were aged 6 months to 9 years (n = 154) and adolescents 10-17 years (n = 77) when they received AS03-adjuvanted A(H1N1)pdm09 vaccine at least 6 months before study enrolment. Hemagglutination inhibition (HI) and neutralizing antibody responses against the A(H1N1)pdm09 strain were evaluated before (day 0) and at day 28 and month 6 after study vaccination. Reactogenicity was assessed during the 7 day postvaccination period, and safety was assessed for 6 months.

RESULTS

At day 0, >93.9% of all children had HI titers ≥1:40 for the A(H1N1)pdm09 strain, which increased to 100% at both day 28 and month 6 in the TIV group. Between days 0 and 28, HI antibody geometric mean titers against A(H1N1)pdm09 increased by 9-fold and 4-fold in children 6 months to 9 years of age and 10-17 years of age, respectively.

CONCLUSION

AS03-adjuvanted A(H1N1)pdm09 vaccine-induced robust immune responses in children that persisted into the next season, yet were still boosted by TIV containing A(H1N1)pdm09. The reactogenicity and safety profile of TIV did not appear compromised by prior receipt of AS03-adjuvanted A(H1N1)pdm09 vaccine.

Authors+Show Affiliations

From the *Vaccine Research Center, University of Tampere Medical School, Tampere, Finland; †Department of Infectious Disease Control, Municipal Public Health Service (GGD) Rotterdam-Rijnmond, Rotterdam, The Netherlands; ‡School of Health Science, Blekinge Institute of Technology, Karlskrona, Sweden; §Childhood Obesity Unit, Skåne University Hospital, Malmö, Sweden; ¶Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden; ‖Department of Clinical Sciences, Umeå University, Umeå, Sweden; **Quanticate, Bangalore, India; ††GSK Vaccines, Wavre, Belgium; ‡‡GSK Vaccines, Rixensart, Belgium; and §§GSK Vaccines, King of Prussia, PA.

Pub Type(s)

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

Language

eng

PubMed ID

26069949

Citation

Vesikari, Timo, et al. "Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine in Children 6 Months to 17 Years of Age, Previously Vaccinated With an AS03-Adjuvanted A(H1N1)Pdm09 Vaccine: Two Open-label, Randomized Trials." The Pediatric Infectious Disease Journal, vol. 34, no. 7, 2015, pp. 774-82.
Vesikari T, Richardus JH, Berglund J, et al. Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine in Children 6 Months to 17 Years of Age, Previously Vaccinated with an AS03-Adjuvanted A(H1N1)Pdm09 Vaccine: Two Open-label, Randomized Trials. Pediatr Infect Dis J. 2015;34(7):774-82.
Vesikari, T., Richardus, J. H., Berglund, J., Korhonen, T., Flodmark, C. E., Lindstrand, A., ... Vaughn, D. W. (2015). Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine in Children 6 Months to 17 Years of Age, Previously Vaccinated with an AS03-Adjuvanted A(H1N1)Pdm09 Vaccine: Two Open-label, Randomized Trials. The Pediatric Infectious Disease Journal, 34(7), pp. 774-82. doi:10.1097/INF.0000000000000709.
Vesikari T, et al. Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine in Children 6 Months to 17 Years of Age, Previously Vaccinated With an AS03-Adjuvanted A(H1N1)Pdm09 Vaccine: Two Open-label, Randomized Trials. Pediatr Infect Dis J. 2015;34(7):774-82. PubMed PMID: 26069949.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine in Children 6 Months to 17 Years of Age, Previously Vaccinated with an AS03-Adjuvanted A(H1N1)Pdm09 Vaccine: Two Open-label, Randomized Trials. AU - Vesikari,Timo, AU - Richardus,Jan Hendrik, AU - Berglund,Johan, AU - Korhonen,Tiina, AU - Flodmark,Carl-Erik, AU - Lindstrand,Ann, AU - Silfverdal,Sven Arne, AU - Bambure,Vinod, AU - Caplanusi,Adrian, AU - Dieussaert,Ilse, AU - Roy-Ghanta,Sumita, AU - Vaughn,David W, PY - 2015/6/13/entrez PY - 2015/6/13/pubmed PY - 2016/3/2/medline SP - 774 EP - 82 JF - The Pediatric infectious disease journal JO - Pediatr. Infect. Dis. J. VL - 34 IS - 7 N2 - BACKGROUND: During the influenza pandemic 2009-2010, an AS03-adjuvanted A(H1N1)pdm09 vaccine was used extensively in children 6 months of age and older, and during the 2010-2011 influenza season, the A(H1N1)pdm09 strain was included in the seasonal trivalent inactivated influenza vaccine (TIV) without adjuvant. We evaluated the immunogenicity and safety of TIV in children previously vaccinated with the AS03-adjuvanted A(H1N1)pdm09 vaccine. METHODS: Healthy children were randomized (1:1) to receive TIV or a control vaccine. Children were aged 6 months to 9 years (n = 154) and adolescents 10-17 years (n = 77) when they received AS03-adjuvanted A(H1N1)pdm09 vaccine at least 6 months before study enrolment. Hemagglutination inhibition (HI) and neutralizing antibody responses against the A(H1N1)pdm09 strain were evaluated before (day 0) and at day 28 and month 6 after study vaccination. Reactogenicity was assessed during the 7 day postvaccination period, and safety was assessed for 6 months. RESULTS: At day 0, >93.9% of all children had HI titers ≥1:40 for the A(H1N1)pdm09 strain, which increased to 100% at both day 28 and month 6 in the TIV group. Between days 0 and 28, HI antibody geometric mean titers against A(H1N1)pdm09 increased by 9-fold and 4-fold in children 6 months to 9 years of age and 10-17 years of age, respectively. CONCLUSION: AS03-adjuvanted A(H1N1)pdm09 vaccine-induced robust immune responses in children that persisted into the next season, yet were still boosted by TIV containing A(H1N1)pdm09. The reactogenicity and safety profile of TIV did not appear compromised by prior receipt of AS03-adjuvanted A(H1N1)pdm09 vaccine. SN - 1532-0987 UR - https://www.unboundmedicine.com/medline/citation/26069949/Immunogenicity_and_Safety_of_a_Trivalent_Inactivated_Influenza_Vaccine_in_Children_6_Months_to_17_Years_of_Age_Previously_Vaccinated_with_an_AS03_Adjuvanted_A_H1N1_Pdm09_Vaccine:_Two_Open_label_Randomized_Trials_ L2 - http://Insights.ovid.com/pubmed?pmid=26069949 DB - PRIME DP - Unbound Medicine ER -