Safety, immunogenicity, and lot-to-lot consistency of a quadrivalent inactivated influenza vaccine in children, adolescents, and adults: A randomized, controlled, phase III trial

Cadorna-Carlos, Josefina B, Nolan, Terry, Borja-Tabora, Charissa Fay, Santos, Jaime, Montalban, M. Cecilia, de Looze, Ferdinandus J, Eizenberg, Peter, Hall, Stephen, Dupuy, Martin, Hutagalung, Yanee, Pepin, Stephanie and Saville, Melanie (2015) Safety, immunogenicity, and lot-to-lot consistency of a quadrivalent inactivated influenza vaccine in children, adolescents, and adults: A randomized, controlled, phase III trial. Vaccine, 33 21: 2485-2492. doi:10.1016/j.vaccine.2015.03.065


Author Cadorna-Carlos, Josefina B
Nolan, Terry
Borja-Tabora, Charissa Fay
Santos, Jaime
Montalban, M. Cecilia
de Looze, Ferdinandus J
Eizenberg, Peter
Hall, Stephen
Dupuy, Martin
Hutagalung, Yanee
Pepin, Stephanie
Saville, Melanie
Title Safety, immunogenicity, and lot-to-lot consistency of a quadrivalent inactivated influenza vaccine in children, adolescents, and adults: A randomized, controlled, phase III trial
Journal name Vaccine   Check publisher's open access policy
ISSN 1873-2518
0264-410X
Publication date 2015-05-15
Year available 2015
Sub-type Article (original research)
DOI 10.1016/j.vaccine.2015.03.065
Open Access Status DOI
Volume 33
Issue 21
Start page 2485
End page 2492
Total pages 8
Place of publication Camden, London, United Kingdom
Publisher Elsevier
Collection year 2016
Language eng
Formatted abstract
Background

Inactivated quadrivalent influenza vaccine (IIV4) containing two influenza A strains and one strain from each B lineage (Yamagata and Victoria) may offer broader protection against seasonal influenza than inactivated trivalent influenza vaccine (IIV3), containing a single B strain. This study examined the safety, immunogenicity, and lot consistency of an IIV4 candidate.

Methods


This phase III, randomized, controlled, multicenter trial in children/adolescents (9 through 17 years) and adults (18 through 60 years) was conducted in Australia and in the Philippines in 2012. The study was double-blind for IIV4 lots and open-label for IIV4 vs IIV3. Children/adolescents were randomized 2:2:2:1 and adults 10:10:10:1 to receive one of three lots of IIV4 or licensed IIV3. Safety data were collected for up to 6 months post-vaccination. Hemagglutination inhibition and seroneutralization antibody titers were assessed pre-vaccination and 21 days post-vaccination.

Results

1648 adults and 329 children/adolescents received IIV4, and 56 adults and 55 children/adolescents received IIV3. Solicited reactions, unsolicited adverse events, and serious adverse events were similar for IIV3 and IIV4 recipients in both age groups. Injection-site pain, headache, malaise, and myalgia were the most frequently reported solicited reactions, most of which were mild and resolved within 3 days. No vaccine-related serious adverse events or deaths were reported. Post-vaccination antibody responses, seroconversion rates, and seroprotection rates for the 3 strains common to both vaccines were comparable for IIV3 and IIV4 in both age groups. Antibody responses to IIV4 were equivalent among vaccine lots and comparable between age groups for each of the 4 strains. IIV4 met all European Medicines Agency immunogenicity criteria for adults for all 4 strains.

Conclusions

In both age groups, IIV4 was well tolerated and caused no safety concerns, induced robust antibody responses to all 4 influenza strains, and met all EMA immunogenicity criteria for adults.
Keyword Influenza
Vaccine
Quadrivalent
Trivalent
Immunogenicity
Safety
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2016 Collection
School of Medicine Publications
 
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