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Immunogenicity and safety of inactivated quadrivalent and trivalent influenza vaccines in children 18-47 months of age.
Pediatr Infect Dis J. 2014 Dec; 33(12):1262-9.PI

Abstract

BACKGROUND

Because inactivated trivalent influenza vaccines (TIVs) contain 1 influenza B strain, whereas 2 lineages may co-circulate, B lineage mismatch is frequent. We assessed an inactivated quadrivalent influenza vaccine (QIV) containing both B lineages versus TIV in young children.

METHODS

Children aged 18-47 months who had received 2 doses of TIV in a study during the previous season (primed cohort, n = 192) were randomized 1:1 to receive 1 dose of TIV or QIV, and a further 407 children (unprimed cohort) were randomized 1:1 to receive 2 doses of TIV or QIV 28 days apart. Immunogenicity was assessed by hemagglutination-inhibition (HI) prevaccination and 28 days after each vaccination. Immunogenic non-inferiority QIV versus TIV for shared strains, and superiority against the alternate-lineage B strain were based on HI geometric mean titers (pooled analyses of primed and half of unprimed cohort with Day 56 immunogenicity assessment). Solicited and unsolicited adverse events were assessed during each 7- and 28-day postvaccination period, respectively (NCT00985790).

RESULTS

Non-inferiority for shared strains and superiority for the alternate-lineage B strain unique to QIV was demonstrated for QIV versus TIV. QIV was immunogenic against all 4 vaccine strains and 87.0%, 88.6%, 69.8% and 97.9% of children had postvaccination titers of ≥ 1:40 against A/H1N1, A/H3N2, B/Victoria and B/Yamagata, respectively. Reactogenicity and safety of QIV was consistent with TIV.

CONCLUSIONS

QIV provided superior immunogenicity for the alternate-lineage B strain compared with TIV without interfering with immune responses to shared strains. Further studies are warranted to assess QIVs in children and to establish the clinical benefits of QIV versus TIV.

Authors+Show Affiliations

From the *Instituto Nacional De Pediatría, Mexico City, Mexico; †GlaxoSmithKline Vaccines, Wavre, Belgium; ‡Centro Medico Adolfo Lopez Mateos, Toluca, Mexico; and §GlaxoSmithKline Vaccines, King of Prussia, Philadelphia, PA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25386965

Citation

Rodriguez Weber, Miguel A., et al. "Immunogenicity and Safety of Inactivated Quadrivalent and Trivalent Influenza Vaccines in Children 18-47 Months of Age." The Pediatric Infectious Disease Journal, vol. 33, no. 12, 2014, pp. 1262-9.
Rodriguez Weber MA, Claeys C, Aranza Doniz C, et al. Immunogenicity and safety of inactivated quadrivalent and trivalent influenza vaccines in children 18-47 months of age. Pediatr Infect Dis J. 2014;33(12):1262-9.
Rodriguez Weber, M. A., Claeys, C., Aranza Doniz, C., Feng, Y., Innis, B. L., Jain, V. K., & Peeters, M. (2014). Immunogenicity and safety of inactivated quadrivalent and trivalent influenza vaccines in children 18-47 months of age. The Pediatric Infectious Disease Journal, 33(12), 1262-9. https://doi.org/10.1097/INF.0000000000000463
Rodriguez Weber MA, et al. Immunogenicity and Safety of Inactivated Quadrivalent and Trivalent Influenza Vaccines in Children 18-47 Months of Age. Pediatr Infect Dis J. 2014;33(12):1262-9. PubMed PMID: 25386965.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Immunogenicity and safety of inactivated quadrivalent and trivalent influenza vaccines in children 18-47 months of age. AU - Rodriguez Weber,Miguel A, AU - Claeys,Carine, AU - Aranza Doniz,Carlos, AU - Feng,Yang, AU - Innis,Bruce L, AU - Jain,Varsha K, AU - Peeters,Mathieu, PY - 2014/11/12/entrez PY - 2014/11/12/pubmed PY - 2015/6/27/medline SP - 1262 EP - 9 JF - The Pediatric infectious disease journal JO - Pediatr. Infect. Dis. J. VL - 33 IS - 12 N2 - BACKGROUND: Because inactivated trivalent influenza vaccines (TIVs) contain 1 influenza B strain, whereas 2 lineages may co-circulate, B lineage mismatch is frequent. We assessed an inactivated quadrivalent influenza vaccine (QIV) containing both B lineages versus TIV in young children. METHODS: Children aged 18-47 months who had received 2 doses of TIV in a study during the previous season (primed cohort, n = 192) were randomized 1:1 to receive 1 dose of TIV or QIV, and a further 407 children (unprimed cohort) were randomized 1:1 to receive 2 doses of TIV or QIV 28 days apart. Immunogenicity was assessed by hemagglutination-inhibition (HI) prevaccination and 28 days after each vaccination. Immunogenic non-inferiority QIV versus TIV for shared strains, and superiority against the alternate-lineage B strain were based on HI geometric mean titers (pooled analyses of primed and half of unprimed cohort with Day 56 immunogenicity assessment). Solicited and unsolicited adverse events were assessed during each 7- and 28-day postvaccination period, respectively (NCT00985790). RESULTS: Non-inferiority for shared strains and superiority for the alternate-lineage B strain unique to QIV was demonstrated for QIV versus TIV. QIV was immunogenic against all 4 vaccine strains and 87.0%, 88.6%, 69.8% and 97.9% of children had postvaccination titers of ≥ 1:40 against A/H1N1, A/H3N2, B/Victoria and B/Yamagata, respectively. Reactogenicity and safety of QIV was consistent with TIV. CONCLUSIONS: QIV provided superior immunogenicity for the alternate-lineage B strain compared with TIV without interfering with immune responses to shared strains. Further studies are warranted to assess QIVs in children and to establish the clinical benefits of QIV versus TIV. SN - 1532-0987 UR - https://www.unboundmedicine.com/medline/citation/25386965/Immunogenicity_and_safety_of_inactivated_quadrivalent_and_trivalent_influenza_vaccines_in_children_18_47_months_of_age_ L2 - http://dx.doi.org/10.1097/INF.0000000000000463 DB - PRIME DP - Unbound Medicine ER -