Efficacy, immunogenicity, and safety of a quadrivalent inactivated influenza vaccine in children aged 6–35 months: A multi-season randomised placebo-controlled trial in the Northern and Southern Hemispheres

Pépin, Stéphanie; Dupuy, Martin; Borja-Tabora, Charissa; Montellano, May; Bravo, Lulu; Santos, Jaime; Castro, Jo-Anne de; Rivera-Medina, Doris Maribel; Cutland, Clare; Ariza, Miguel; Díez-Domingo, Javier; González, Celia Díaz; Martinón-Torres, Federico; Papadopoulou‐Alataki, Efimia; Theodoriadou, Maria; Kazek-Duret, Marie Pierre; Gurunathan, Sanjay; Bruijn, Iris De

doi:10.1016/j.vaccine.2018.11.074

Cited by 41 publications

(37 citation statements)

References 24 publications

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“…No severe (grade 3) systemic reactions were reported in participants aged ≥9 years. Consistent with previous QIV studies, 6,7,16 most systemic reactions were mild or moderate (grade 1 or 2) in intensity, started within 7 days after vaccine injection, and lasted 1 − 7 days. In previously unvaccinated children, four severe (grade 3) solicited systemic reactions were reported within 7 days after the first vaccine injection: two children aged 6 − 35 months and two children aged 3 − 8 years experienced high fever (39.5°C to 39.7°C) after the first vaccine injection.…”

supporting

confidence: 88%

“…Erythema also tended to be more frequent after the first dose in children 6 − 35 months and 3 − 8 years. Similar to previous studies of QIV, 6,7,16 all solicited injection-site reactions were mild or moderate (grade 1 or 2) in intensity, started within 3 days after vaccine injection, and lasted 1 − 3 days and there was a trend of lower incidence of adverse reactions after the second injection compared to the first one in children aged 6 − 35 months.…”

supporting

confidence: 85%

“…[5][6][7]16 QIV was well tolerated by all age groups, and the observed solicited injection site and systemic reactions are consistent with the frequencies observed in other populations. [5][6][7]16 One limitation of this study could be the relatively small size of the study population, especially in older adults aged >60 years (N = 20) for whom annual influenza vaccination is recommended. 2 However, the safety profile for the elderly population is expected to be consistent, as for other age groups, with phase III studies of QIV in which this study population is well represented.…”

supporting

confidence: 85%

“…AEs were defined according to the International Conference on Harmonization E2A guideline for Clinical Safety Data Management and Definitions and Standards for Expedited Reporting. 16 Abbreviations: AE, adverse event; AR, adverse reaction; CI, confidence interval; SAE, serious adverse event a Headache, malaise, myalgia, and shivering were assessed only in participants ≥24 months of age. Vomiting, crying abnormally, drowsiness, appetite loss, and irritability were assessed only in children ≤23 months of age.…”

mentioning

confidence: 99%

“…2 However, the safety profile for the elderly population is expected to be consistent, as for other age groups, with phase III studies of QIV in which this study population is well represented. [5][6][7]16 As this is a singlecenter, open-label trial, reporting of AEs may not be sufficiently representative of the actual safety profile, and rare adverse events may not be addressed adequately due to the small sample size. However, larger safety studies for QIV have been conducted globally for initial vaccine registration and the safety profile of QIV is consistent with these other studies.…”

mentioning

confidence: 99%

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Safety of a quadrivalent influenza vaccine in Vietnamese healthy subjects aged 6 months and older

Thiểm

Chabanon

Fournier

et al. 2020

Human Vaccines & Immunotherapeutics

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Quadrivalent influenza vaccines (QIVs) provide protection against the two influenza A viruses (H1N1 and H3N2) and both co-circulating influenza B lineages. QIVs have been found safe, immunogenic, and efficacious in several phase III clinical trials. Here we assess the safety of QIV after vaccination in Vietnamese infants, children, and adults. Participants (n = 228) were asked to report any solicited adverse events (AEs) occurring within 7 days, unsolicited non-serious AEs occurring within 28 days postvaccination, and serious adverse events (SAEs) at any time during the study. The study was completed by 224 participants (97.4%). Thirty-one children (39.7%) aged 6 − 35 months, 32 children (40.0%) aged 3 − 8 years, 2 participants (9.0%) aged 9 − 17 years, 5 participants (17.9%) aged 18 − 60 years, and 3 participants (15.0%) aged ≥60 years reported ≥1 solicited reaction within 7 days following vaccination. The most frequent-solicited AEs were injection-site tenderness or pain, appetite loss, fever, and abnormal crying in 6 − 35 month-olds, and fever, headache, and myalgia in other age groups. No severe-unsolicited AEs or vaccine-related SAEs were reported. These results suggest that QIV is well tolerated across age groups in Vietnam, and can be safely used to protect the Vietnamese population against influenza and its potentially serious complications.

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supporting

confidence: 88%

supporting

confidence: 85%

supporting

confidence: 85%

mentioning

confidence: 99%

mentioning

confidence: 99%

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Safety of a quadrivalent influenza vaccine in Vietnamese healthy subjects aged 6 months and older

Thiểm

Chabanon

Fournier

et al. 2020

Human Vaccines & Immunotherapeutics

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Post-Marketing Safety Surveillance of Quadrivalent Influenza Vaccine (VaxigripTetra) in Children Aged 6 to 35 Months in South Korea

Choe¹,

Talanova²,

Shin³

et al. 2023

Infect Dis Ther

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Introduction The quadrivalent inactivated split-virion influenza vaccine (QIV; VaxigripTetra ® ) was initially licensed in South Korea in 2017 for immunization against seasonal influenza in those aged ≥ 3 years, with the indicated age subsequently lowered to include those aged ≥ 6 months in 2018. Here, to comply with South Korean licensure requirements, we undertook a post-marketing surveillance study to assess the safety of QIV in children aged 6–35 months (i.e., extension of the previous age indication to include these young children) in routine clinical practice. Methods A multicenter, observational, active safety surveillance of children aged 6–35 months who received a single dose of QIV during a routine healthcare visit was undertaken in South Korea from 15 June 2018 to 14 June 2022. Solicited adverse events (AEs) and unsolicited non-serious AEs were recorded in diary cards, with serious adverse events (SAEs) notified to study investigators. Results This safety analysis included 676 participants. No AEs led to study termination, and no SAEs were reported. The most frequent solicited injection site reaction was pain in both the ≤ 23-month (12.2% [55/450]) and ≥ 24-month (15.5% [35/226]) age groups. The most frequent solicited systemic reactions were pyrexia and somnolence in the ≤ 23-month age group (6.0% [27/450] each), and malaise (10.6% [24/226]) in the ≥ 24-month age group. Overall, 208 (30.8%) participants experienced 339 unsolicited non-serious AEs, with nasopharyngitis the most common (14.1% [95/676]), and nearly all events (98.8% [335/339]) were considered unrelated to QIV. Grade 3 solicited reactions and unsolicited non-serious AEs were reported in five (0.7%) and three (0.4%) participants, respectively, all of whom recovered by day 7 after vaccination. Conclusion This active safety surveillance study confirms that QIV is well tolerated in children aged 6–35 months in routine clinical practice in South Korea. There were no safety concerns observed in these young children.

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Influenza epidemics

Wautlet

Patel

Chávez

et al. 2021

Annals of Allergy, Asthma & Immunology

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Efficacy, immunogenicity, and safety of a quadrivalent inactivated influenza vaccine in children aged 6–35 months: A multi-season randomised placebo-controlled trial in the Northern and Southern Hemispheres

Cited by 41 publications

References 24 publications

Safety of a quadrivalent influenza vaccine in Vietnamese healthy subjects aged 6 months and older

Safety of a quadrivalent influenza vaccine in Vietnamese healthy subjects aged 6 months and older

Post-Marketing Safety Surveillance of Quadrivalent Influenza Vaccine (VaxigripTetra) in Children Aged 6 to 35 Months in South Korea

Influenza epidemics

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Efficacy, immunogenicity, and safety of a quadrivalent inactivated influenza vaccine in children aged 6–35 months: A multi-season randomised placebo-controlled trial in the Northern and Southern Hemispheres

Cited by 41 publications

References 24 publications

Safety of a quadrivalent influenza vaccine in Vietnamese healthy subjects aged 6 months and older

Safety of a quadrivalent influenza vaccine in Vietnamese healthy subjects aged 6 months and older

Post-Marketing Safety Surveillance of Quadrivalent Influenza Vaccine (VaxigripTetra) in Children Aged 6 to 35 Months in South Korea

Influenza epidemics

Contact Info

Product

Resources

About

Efficacy, immunogenicity, and safety of a quadrivalent inactivated influenza vaccine in children aged 6–35 months: A multi-season randomised placebo-controlled trial in the Northern and Southern Hemispheres