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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
Joanne M. Langleya, Corresponding author contact information, E-mail the corresponding author,
David W. Scheifeleb, E-mail the corresponding author,
Caroline Quachc, E-mail the corresponding author,
Otto G. Vanderkooid, E-mail the corresponding author,
Brian Wardc, E-mail the corresponding author,
Shelly McNeila, E-mail the corresponding author,
Simon Dobsonb, E-mail the corresponding author,
James D. Kellnerd, E-mail the corresponding author,
Susan Kuhnd, E-mail the corresponding author,
Tobias Kollmanb, E-mail the corresponding author,
Donna MacKinnon-Camerona, E-mail the corresponding author,
Bruce Smitha, E-mail the corresponding author,
Yan Lie, E-mail the corresponding author,
Scott A. Halperina, E-mail the corresponding author
a Canadian Center for Vaccinology, Dalhousie University and IWK Health Centre Halifax, 5850 University Avenue, Halifax, Nova Scotia, B3K 6R8, Canada
b Vaccine Evaluation Center, British Columbia Children's Hospital and the University of British Columbia, Vancouver, Canada
c McGill University Health Centre ? Vaccine Study Centre, McGill University, Montreal, Quebec, Canada
d Department of Paediatrics, University of Calgary and Alberta Health Services-Calgary Zone, Alberta Children's Hospital, Calgary, Alberta, Canada
e National Microbiology Laboratory, Winnipeg, Manitoba, Canada
Received 19 September 2011. Revised 11 February 2012. Accepted 19 March 2012. Available online 30 March 2012.
http://dx.doi.org/10.1016/j.vaccine.2012.03.046, How to Cite or Link Using DOI
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.
Joanne M. Langleya, Corresponding author contact information, E-mail the corresponding author,
David W. Scheifeleb, E-mail the corresponding author,
Caroline Quachc, E-mail the corresponding author,
Otto G. Vanderkooid, E-mail the corresponding author,
Brian Wardc, E-mail the corresponding author,
Shelly McNeila, E-mail the corresponding author,
Simon Dobsonb, E-mail the corresponding author,
James D. Kellnerd, E-mail the corresponding author,
Susan Kuhnd, E-mail the corresponding author,
Tobias Kollmanb, E-mail the corresponding author,
Donna MacKinnon-Camerona, E-mail the corresponding author,
Bruce Smitha, E-mail the corresponding author,
Yan Lie, E-mail the corresponding author,
Scott A. Halperina, E-mail the corresponding author
a Canadian Center for Vaccinology, Dalhousie University and IWK Health Centre Halifax, 5850 University Avenue, Halifax, Nova Scotia, B3K 6R8, Canada
b Vaccine Evaluation Center, British Columbia Children's Hospital and the University of British Columbia, Vancouver, Canada
c McGill University Health Centre ? Vaccine Study Centre, McGill University, Montreal, Quebec, Canada
d Department of Paediatrics, University of Calgary and Alberta Health Services-Calgary Zone, Alberta Children's Hospital, Calgary, Alberta, Canada
e National Microbiology Laboratory, Winnipeg, Manitoba, Canada
Received 19 September 2011. Revised 11 February 2012. Accepted 19 March 2012. Available online 30 March 2012.
http://dx.doi.org/10.1016/j.vaccine.2012.03.046, How to Cite or Link Using DOI
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.
