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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. 2015 May 15; 33(21):2485-92.V

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.

CLINICAL TRIAL REGISTRY NUMBER

NCT01481454.

Authors+Show Affiliations

University of the East Ramon Magsaysay Memorial Medical Center, 64 Aurora Boulevard, Barangay Doña Imelda, Quezon City, Philippines. Electronic address: jccarlosmd@yahoo.com.Melbourne School of Population and Global Health, University of Melbourne, 207 Bouverie Street, Melbourne, Victoria 3010, Australia. Electronic address: t.nolan@unimelb.edu.au.Research Institute for Tropical Medicine, Corporate Ave, Muntinlupa City, Metro Manila, Philippines. Electronic address: cbtabora@yahoo.com.Philippine Children's Medical Center, Agham Road, Quezon City, Metro Manila, Philippines. Electronic address: jimson2@me.com.Our Lady of Remedies Clinic, Manila, Philippines. Electronic address: csmontalban@yahoo.com.AusTrials, 14 Primrose Street, Sherwood, Queensland 4075, Australia; School of Medicine, University of Queensland, Queensland 4072, Australia. Electronic address: freddelooze@austrials.com.au.Doctors of Ivanhoe, 131 Upper Heidelberg Rd, Ivanhoe, Victoria 3079, Australia. Electronic address: peter@dr131.com.au.Emeritus Research, 291 Wattletree Rd, Malvern East, Victoria 3145, Australia. Electronic address: stephenhall@emeritusresearch.com.Sanofi Pasteur, 1541 Avenue Marcel Mérieux, 69280 Marcy-l'Étoile, France. Electronic address: Martin.Dupuy@sanofipasteur.com.Sanofi Pasteur, 6 Raffles Quay, 048580, Singapore. Electronic address: buddy.bello@gmail.com.Sanofi Pasteur, 1541 Avenue Marcel Mérieux, 69280 Marcy-l'Étoile, France. Electronic address: Stephanie.Pepin@sanofipasteur.com.Sanofi Pasteur, 1541 Avenue Marcel Mérieux, 69280 Marcy-l'Étoile, France. Electronic address: Melanie.Saville@sanofipasteur.com.

Pub Type(s)

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

Language

eng

PubMed ID

25843270

Citation

Cadorna-Carlos, Josefina B., et al. "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, vol. 33, no. 21, 2015, pp. 2485-92.
Cadorna-Carlos JB, Nolan T, Borja-Tabora CF, et al. 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. 2015;33(21):2485-92.
Cadorna-Carlos, J. B., Nolan, T., Borja-Tabora, C. F., Santos, J., Montalban, M. C., de Looze, F. J., Eizenberg, P., Hall, S., Dupuy, M., Hutagalung, Y., Pépin, S., & Saville, M. (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), 2485-92. https://doi.org/10.1016/j.vaccine.2015.03.065
Cadorna-Carlos JB, et al. 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. 2015 May 15;33(21):2485-92. PubMed PMID: 25843270.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety, immunogenicity, and lot-to-lot consistency of a quadrivalent inactivated influenza vaccine in children, adolescents, and adults: A randomized, controlled, phase III trial. AU - Cadorna-Carlos,Josefina B, AU - Nolan,Terry, AU - Borja-Tabora,Charissa Fay, AU - Santos,Jaime, AU - Montalban,M Cecilia, AU - de Looze,Ferdinandus J, AU - Eizenberg,Peter, AU - Hall,Stephen, AU - Dupuy,Martin, AU - Hutagalung,Yanee, AU - Pépin,Stéphanie, AU - Saville,Melanie, Y1 - 2015/04/02/ PY - 2014/09/24/received PY - 2015/03/22/revised PY - 2015/03/23/accepted PY - 2015/4/7/entrez PY - 2015/4/7/pubmed PY - 2016/1/20/medline KW - Immunogenicity KW - Influenza KW - Quadrivalent KW - Safety KW - Trivalent KW - Vaccine SP - 2485 EP - 92 JF - Vaccine JO - Vaccine VL - 33 IS - 21 N2 - 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. CLINICAL TRIAL REGISTRY NUMBER: NCT01481454. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/25843270/Safety_immunogenicity_and_lot_to_lot_consistency_of_a_quadrivalent_inactivated_influenza_vaccine_in_children_adolescents_and_adults:_A_randomized_controlled_phase_III_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(15)00384-9 DB - PRIME DP - Unbound Medicine ER -