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Safety and immunogenicity of 2010-2011 H1N12009-containing trivalent inactivated influenza vaccine in children 12-59 months of age previously given AS03-adjuvanted H1N12009 pandemic vaccine: a PHAC/CIHR Influenza Research Network (PCIRN) study.
Vaccine 2012; 30(23):3389-94V

Abstract

BACKGROUND

Concern arose in 2010 that reactogenicity, particularly febrile seizures, to influenza A/H1N1-containing 2010-2011 trivalent seasonal inactivated influenza vaccine (TIV) could occur in young children who had been previously immunized and/or infected with the pandemic strain. We conducted a pre-season study of 2010-2011 TIV safety and immunogenicity in children 12-59 months of age to inform public health decision making.

METHODS

Children immunized with 1 or 2 doses of the pandemic vaccine, with or without the 2009-10 TIV, received 1 or 2 doses of 2010-11 TIV in an observational, multicentre Canadian study. Standard safety monitoring was enhanced by a telephone call at ~24 h post-TIV when adverse events were expected to peak. Summary safety reports were rapidly reported to public health before the launch of public programs. TIV immunogenicity was assessed day 0, and 21 days after final vaccination. Clinical Trials Registration NCT01180621.

RESULTS

Among 207 children, a general adverse event was reported by 60.9% of children post-dose one and by 58.3% post-dose two. Only severe fever (>38.5°C) was more common in two-dose compared to one dose recipients (16.7%, n=4 v. 1.0%, n=2). At baseline 99.0% of participants had A/H1N1 hemagglutinin inhibition (HAI) titers ≥10, and 85.5% had a protective titer of ≥40 (95% CI 80.0, 90.0). Baseline geometric mean titers (GMT) were higher in recipients of a 2-dose schedule of pandemic vaccine compared to one-dose recipients: 153.1 (95% CI 126.2, 185.7) v. 78.8 ((58.1, 106.8, p<0.001). At 21 days, all regulatory criteria for influenza vaccine immunogenicity were exceeded for A/H1N1 and H3N2, but responses to the B antigen were poor. No correlations between reactogenicity and either baseline high influenza titers or serologic response to revaccination were evident.

CONCLUSIONS

Infants and toddlers who received AS03-adjuvanted A/H1N1 2009 vaccine up to 11 months earlier retained high titers in the subsequent season but re-exposure to A/H1N1 2009 antigen in TIV resulted in no unusual adverse effects and 100% were sero-protected for A/H1N1 after receipt of the 2010-11 TIV.

Authors+Show Affiliations

Canadian Center for Vaccinology, Dalhousie University and IWK Health Centre Halifax, Halifax, Nova Scotia, B3K 6R8, Canada. Joanne.Langley@dal.caNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

22469860

Citation

Langley, Joanne M., et al. "Safety and Immunogenicity of 2010-2011 H1N12009-containing Trivalent Inactivated Influenza Vaccine in Children 12-59 Months of Age Previously Given AS03-adjuvanted H1N12009 Pandemic Vaccine: a PHAC/CIHR Influenza Research Network (PCIRN) Study." Vaccine, vol. 30, no. 23, 2012, pp. 3389-94.
Langley JM, Scheifele DW, Quach C, et al. Safety and immunogenicity of 2010-2011 H1N12009-containing trivalent inactivated influenza vaccine in children 12-59 months of age previously given AS03-adjuvanted H1N12009 pandemic vaccine: a PHAC/CIHR Influenza Research Network (PCIRN) study. Vaccine. 2012;30(23):3389-94.
Langley, J. M., Scheifele, D. W., Quach, C., Vanderkooi, O. G., Ward, B., McNeil, S., ... Halperin, S. A. (2012). Safety and immunogenicity of 2010-2011 H1N12009-containing trivalent inactivated influenza vaccine in children 12-59 months of age previously given AS03-adjuvanted H1N12009 pandemic vaccine: a PHAC/CIHR Influenza Research Network (PCIRN) study. Vaccine, 30(23), pp. 3389-94. doi:10.1016/j.vaccine.2012.03.046.
Langley JM, et al. Safety and Immunogenicity of 2010-2011 H1N12009-containing Trivalent Inactivated Influenza Vaccine in Children 12-59 Months of Age Previously Given AS03-adjuvanted H1N12009 Pandemic Vaccine: a PHAC/CIHR Influenza Research Network (PCIRN) Study. Vaccine. 2012 May 14;30(23):3389-94. PubMed PMID: 22469860.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and immunogenicity of 2010-2011 H1N12009-containing trivalent inactivated influenza vaccine in children 12-59 months of age previously given AS03-adjuvanted H1N12009 pandemic vaccine: a PHAC/CIHR Influenza Research Network (PCIRN) study. AU - Langley,Joanne M, AU - Scheifele,David W, AU - Quach,Caroline, AU - Vanderkooi,Otto G, AU - Ward,Brian, AU - McNeil,Shelly, AU - Dobson,Simon, AU - Kellner,James D, AU - Kuhn,Susan, AU - Kollman,Tobias, AU - MacKinnon-Cameron,Donna, AU - Smith,Bruce, AU - Li,Yan, AU - Halperin,Scott A, Y1 - 2012/03/30/ PY - 2011/09/19/received PY - 2012/02/11/revised PY - 2012/03/19/accepted PY - 2012/4/4/entrez PY - 2012/4/4/pubmed PY - 2012/8/9/medline SP - 3389 EP - 94 JF - Vaccine JO - Vaccine VL - 30 IS - 23 N2 - BACKGROUND: Concern arose in 2010 that reactogenicity, particularly febrile seizures, to influenza A/H1N1-containing 2010-2011 trivalent seasonal inactivated influenza vaccine (TIV) could occur in young children who had been previously immunized and/or infected with the pandemic strain. We conducted a pre-season study of 2010-2011 TIV safety and immunogenicity in children 12-59 months of age to inform public health decision making. METHODS: Children immunized with 1 or 2 doses of the pandemic vaccine, with or without the 2009-10 TIV, received 1 or 2 doses of 2010-11 TIV in an observational, multicentre Canadian study. Standard safety monitoring was enhanced by a telephone call at ~24 h post-TIV when adverse events were expected to peak. Summary safety reports were rapidly reported to public health before the launch of public programs. TIV immunogenicity was assessed day 0, and 21 days after final vaccination. Clinical Trials Registration NCT01180621. RESULTS: Among 207 children, a general adverse event was reported by 60.9% of children post-dose one and by 58.3% post-dose two. Only severe fever (>38.5°C) was more common in two-dose compared to one dose recipients (16.7%, n=4 v. 1.0%, n=2). At baseline 99.0% of participants had A/H1N1 hemagglutinin inhibition (HAI) titers ≥10, and 85.5% had a protective titer of ≥40 (95% CI 80.0, 90.0). Baseline geometric mean titers (GMT) were higher in recipients of a 2-dose schedule of pandemic vaccine compared to one-dose recipients: 153.1 (95% CI 126.2, 185.7) v. 78.8 ((58.1, 106.8, p<0.001). At 21 days, all regulatory criteria for influenza vaccine immunogenicity were exceeded for A/H1N1 and H3N2, but responses to the B antigen were poor. No correlations between reactogenicity and either baseline high influenza titers or serologic response to revaccination were evident. CONCLUSIONS: Infants and toddlers who received AS03-adjuvanted A/H1N1 2009 vaccine up to 11 months earlier retained high titers in the subsequent season but re-exposure to A/H1N1 2009 antigen in TIV resulted in no unusual adverse effects and 100% were sero-protected for A/H1N1 after receipt of the 2010-11 TIV. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/22469860/Safety_and_immunogenicity_of_2010_2011_H1N12009_containing_trivalent_inactivated_influenza_vaccine_in_children_12_59_months_of_age_previously_given_AS03_adjuvanted_H1N12009_pandemic_vaccine:_a_PHAC/CIHR_Influenza_Research_Network__PCIRN__study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(12)00438-0 DB - PRIME DP - Unbound Medicine ER -