Safety and Immunogenicity of a Full-dose, Split-virion, Inactivated, Quadrivalent Influenza Vaccine in Healthy Children 6-35 Months of Age

Robertson, Corwin A.; Mercer, Monica; Selmani, Alexandre; Klein, Nicola P.; Jeanfreau, Robert; Greenberg, David

doi:10.1097/inf.0000000000002227

Cited by 21 publications

(16 citation statements)

References 19 publications

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“…Vaccines more similar to currently available split-virus inactivated products have demonstrated less reactogenicity ( 34 ). Since November 2016, three IIV4s (Fluarix Quadrivalent, FluLaval Quadrivalent, and Fluzone Quadrivalent) have been approved for administration to this age group at the higher 0.5-mL dose (containing 15 µ g of HA per vaccine virus) on the basis of studies demonstrating acceptable safety profiles ( 35 – 37 ).…”

Section: Recommendations For the Use Of Influenza Vaccines 2019–20mentioning

confidence: 99%

“…Licensure of the 0.5-mL dose volume for this age group was based on a randomized, observer-blinded, multicenter safety and immunogenicity study conducted among 1,950 children aged 6 through 35 months, who were randomized 1:1 to receive either 0.25 mL or 0.5 mL of Fluzone Quadrivalent ( 37 , 108 ). In the safety analysis, the overall safety profile was similar between the two groups.…”

Section: Influenza Vaccine Composition and Available Productsmentioning

confidence: 99%

See 1 more Smart Citation

Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices — United States, 2019–20 Influenza Season

Grohskopf¹,

Alyanak²,

Broder³

et al. 2019

MMWR Recomm. Rep.

388

383

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Summary This report updates the 2018–19 recommendations of the Advisory Committee on Immunization Practices (ACIP) regarding the use of seasonal influenza vaccines in the United States (MMWR Recomm Rep 2018;67[No. RR-3]). Routine annual influenza vaccination is recommended for all persons aged ≥6 months who do not have contraindications. A licensed, recommended, and age-appropriate vaccine should be used. Inactivated influenza vaccines (IIVs), recombinant influenza vaccine (RIV), and live attenuated influenza vaccine (LAIV) are expected to be available for the 2019–20 season. Standard-dose, unadjuvanted, inactivated influenza vaccines will be available in quadrivalent formulations (IIV4s). High-dose (HD-IIV3) and adjuvanted (aIIV3) inactivated influenza vaccines will be available in trivalent formulations. Recombinant (RIV4) and live attenuated influenza vaccine (LAIV4) will be available in quadrivalent formulations. Updates to the recommendations described in this report reflect discussions during public meetings of ACIP held on October 25, 2018; February 27, 2019; and June 27, 2019. Primary updates in this report include the following two items. First, 2019–20 U.S. trivalent influenza vaccines will contain hemagglutinin (HA) derived from an A/Brisbane/02/2018 (H1N1)pdm09–like virus, an A/Kansas/14/2017 (H3N2)–like virus, and a B/Colorado/06/2017–like virus (Victoria lineage). Quadrivalent influenza vaccines will contain HA derived from these three viruses, and a B/Phuket/3073/2013–like virus (Yamagata lineage). Second, recent labeling changes for two IIV4s, Afluria Quadrivalent and Fluzone Quadrivalent, are discussed. The age indication for Afluria Quadrivalent has been expanded from ≥5 years to ≥6 months. The dose volume for Afluria Quadrivalent is 0.25 mL for children aged 6 through 35 months and 0.5 mL for all persons aged ≥36 months (≥3 years). The dose volume for Fluzone Quadrivalent for children aged 6 through 35 months, which was previously 0.25 mL, is now either 0.25 mL or 0.5 mL. The dose volume for Fluzone Quadrivalent is 0.5 mL for all persons aged ≥36 months (≥3 years). This report focuses on the recommendations for use of vaccines for the prevention and control of influenza during the 2019–20 season in the United States. A brief summary of these recommendations and a Background Document containing additional information are available at https://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/flu.html . These recommendations apply to U.S.-licensed influenza vaccines used within Food and Drug Administration–licensed indications. Updates and other information are available from CDC’s influenza website ( https://www.cdc.gov/flu ). Vaccination and health care providers should check this site periodically for additional information.

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Section: Recommendations For the Use Of Influenza Vaccines 2019–20mentioning

confidence: 99%

Section: Influenza Vaccine Composition and Available Productsmentioning

confidence: 99%

Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices — United States, 2019–20 Influenza Season

Grohskopf¹,

Alyanak²,

Broder³

et al. 2019

MMWR Recomm. Rep.

388

383

View full text Add to dashboard Cite

show abstract

“…In the first trial, full dose Fluzone had a similar safety profile to half-dose Fluzone with a single adverse event being attributed to the study vaccine. 13 Similarly, the second study found that full-dose Flulaval may improve protection against influenza in some young children when compared to low-dose Fluzone, and in this trial none of the adverse events were considered to be study-related by the investigator. 11 The final trial evaluated Vaxigrip Tetra (15μg/strain) administered to children and adolescents in two different formats.…”

Section: Resultsmentioning

confidence: 87%

“…Four of the included studies evaluated quadrivalent influenza vaccines (QIV) in children. 5, 11-13 All of the studies reported reactogenicity outcomes and adverse events. One study reported both TIV and QIV vaccines and the results are reported above.…”

Section: Resultsmentioning

confidence: 99%

Safety and effectiveness of dose-sparing strategies for seasonal influenza vaccine

Antony

2020

Preprint

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Background: The objective of this rapid scoping review was to identify potentially safe and effective dose-sparing strategies for intramuscular administration of seasonal influenza vaccines in healthy individuals of all ages. Methods: Comprehensive literature searches were developed and executed in MEDLINE, EMBASE, and the Cochrane library, and grey literature was searched via international clinical trial registries for relevant studies published in English in the last 20 years. References of relevant systematic reviews and included studies were also scanned. Title/abstract and full-text screening were carried out by pairs of reviewers independently and data charting conducted by a single reviewer and verified by a second reviewer. Results were presented narratively. Results: A total of 13 studies with 10,351 participants were included in the review and all studies were randomized control trials conducted between 2006 and 2019. The most common interventions were the trivalent influenza vaccine (n=10), followed by quadrivalent influenza vaccine (n=4). Nine studies included infants/toddlers 6-36 months old and one of these studies also included children and adolescents. In these nine studies, no clinical effectiveness outcomes were reported and no difference was found in local and systemic reactogenicity between dosing strategies. Of the four adult studies (≥ 18 years), the two studies that reported on effectiveness outcomes found similar results between the half-dose and full-dose vaccination groups and all four studies reported no differences in safety outcomes between groups. Conclusion: The current evidence for the administration of intramuscular influenza vaccines suggests there is no significant difference in safety and clinical effectiveness with the use of low-dose compared to full-dose vaccines, which is promising given the predicted resource constraints in the upcoming influenza season due to the 2019 novel coronavirus. Due to the low number of studies in adults and the lack of studies assessing confirmed influenza and influenza-like illness, there remains a need for further evaluation.

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“…Studies have generally shown comparable reactogenicity and non-inferior immunogenicity with the full dose, in comparison with the half dose, in children 6-35 months of age [22][23][24][25]. Statistically superior immunogenicity was seen only in infants between 6-11 months of age, for H3N2 and B/Yamagata and not for H1N1 [25].…”

Section: Uniform Dosing For Inactivated Influenza Vaccinesmentioning

confidence: 97%

Indian Academy of Pediatrics (IAP) Advisory Committee on Vaccines and Immunization Practices (ACVIP): Recommended Immunization Schedule (2020–21) and Update on Immunization for Children Aged 0 Through 18 Years

Kasi¹,

Shivananda

Marathe³

et al. 2020

Indian Pediatr

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In view of new developments in vaccinology and the availability of new vaccines, there is a need to revise/review the existing immunization recommendations. Process: Advisory Committee on Vaccines and Immunization Practices (ACVIP) of Indian Academy of Pediatrics (IAP) had a physical meeting in March, 2020 followed by online meetings (September-October, 2020), to discuss the updates and new recommendations. Opinion of each member was sought on the various recommendations and updates, following which an evidence-based consensus was reached. Objectives: To review and revise the IAP recommendations for 2020-21 and issue recommendations on existing and new vaccines. Recommendations: The major changes include recommendation of a booster dose of injectable polio vaccine (IPV) at 4-6 years for children who have received the initial IPV doses as per the ACVIP/IAP schedule, reemphasis on the importance of IPV in the primary immunization schedule, preferred timing of second dose of varicella vaccine at 3-6 months after the first dose, and uniform dosing recommendation of 0.5 mL (15 µg HA) for inactivated influenza vaccines.

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Safety and Immunogenicity of a Full-dose, Split-virion, Inactivated, Quadrivalent Influenza Vaccine in Healthy Children 6-35 Months of Age

Abstract: Supplemental Digital Content is available in the text.

Cited by 21 publications

References 19 publications

Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices — United States, 2019–20 Influenza Season

Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices — United States, 2019–20 Influenza Season

Safety and effectiveness of dose-sparing strategies for seasonal influenza vaccine

Indian Academy of Pediatrics (IAP) Advisory Committee on Vaccines and Immunization Practices (ACVIP): Recommended Immunization Schedule (2020–21) and Update on Immunization for Children Aged 0 Through 18 Years

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