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Vaccine. 2014 Oct 21;32(46):6146-56. doi: 10.1016/j.vaccine.2014.08.068. Epub 2014 Sep 16.

Enhanced and persistent antibody response against homologous and heterologous strains elicited by a MF59-adjuvanted influenza vaccine in infants and young children.

Author information

1
Melbourne School of Population and Global Health, and the Murdoch Childrens Research Institute, University of Melbourne, Melbourne, Australia. Electronic address: t.nolan@unimelb.edu.au.
2
Philippine General Hospital, University of the Philippines Manila, Manila, Metro Manila, Philippines.
3
Instituto Médico Rio Cuarto, Cordoba, Cordoba Province, Argentina.
4
Newtown Clinical Research Centre, Johannesburg, Gauteng Province, South Africa.
5
Chris Hani Baragwanath Hospital, University of Witwatersrand, Johannesburg, Gauteng Province, South Africa.
6
Research Institute for Tropical Medicine, Muntinlupa, Metro Manila, Philippines.
7
Novartis Vaccines and Diagnostics, Inc., Cambridge, MA, USA.

Abstract

BACKGROUND:

Non-adjuvanted seasonal influenza vaccines show only modest efficacy in young children. This study compared the immunogenicity, reactogenicity and safety of the MF59-adjuvanted trivalent subunit vaccine (aTIV) with two non-adjuvanted trivalent vaccines, TIV-1, the non-adjuvanted version of aTIV, and TIV-2, a split virion vaccine.

METHODS:

6078 children received two doses of aTIV (n=3125), TIV-1 (n=1479), or TIV-2 (n=1474) four weeks apart (Days 1 and 29). Children aged 6 to <36 months and 36 to <72 months received 0.25 mL and 0.50 mL doses, respectively. Immunogenicity was assessed by hemagglutination inhibition (HI) assay (n=2435) on Days 1, 29, 50 and 209. Safety was assessed up to Day 394.

RESULTS:

After the second vaccination (Day 50), the aTIV group showed significantly higher geometric mean HI titers and seroconversion rates than the TIV-1 or TIV-2 groups against all homologous and heterologous strains. The difference was enhanced at HI titers ≥110. aTIV elicited a faster, more persistent antibody response, with significantly higher titers in the aTIV group after one vaccination (Day 29) and after six months (Day 209) than in either TIV group. aTIV was more reactogenic than were TIV-1 and TIV-2 but rates of severe adverse events were very low for all three vaccines.

CONCLUSION:

In infants and young children, the MF59-adjuvanted vaccine induced substantially faster (after one dose), higher, persistent HI titers than the non-adjuvanted vaccines, with consistently higher seroprotection rates at increased threshold HI titers. This trial is registered at clinicaltrials.gov: NCT01346592.

KEYWORDS:

(www.clinicaltrials.gov): NCT01346592; Adjuvant; Children; Fluad(®); Influenza vaccine; MF59

PMID:
25223266
DOI:
10.1016/j.vaccine.2014.08.068
[Indexed for MEDLINE]

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