Immunogenicity and safety of a fully liquid DTaP-IPV-HB-PRP∼T hexavalent vaccine compared with the standard of care in infants in the Republic of Korea

Kim, Yun-Kyung; Vidor, Emmanuel; Kim, Hwang Min; Shin, Son Moon; Lee, Kyung-Yil; Cha, Sung-Ho; Hyuk, Sang; Kim, Dong Ho; Jin, Lei; Park, Su Eun; Lee, Hyunju; Kim, Jong-Duk; Kim, Ki Hwan; Kim, Kyung-Hyo; Kim, Jong-Hyun

doi:10.1016/j.vaccine.2017.05.062

Cited by 13 publications

(32 citation statements)

References 21 publications

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“…In the study that randomized infants to receive HB vaccination at birth or not (A3L15 [17]), anti-HB post-primary (Table 1) and post-booster (Table 3) seroprotection rates were numerically similar in both groups, although HB vaccination at birth was associated with numerically higher LTPT rates and GMCs at all assessment timepoints. This finding was broadly supported by individual studies which included infants who had [7, 10, 11, 13, 20, 21] or had not [8, 9, 12, 14, 18, 19] received HB vaccination at birth and a pooled analysis of infants who had not received HB vaccination at birth [25]. Post hoc analyses showed that anti-HB post-booster seroprotection rate was independent of pre-booster GMCs (< 10 vs. ≥ 10 mIU/mL) [9, 23].…”

Section: Immunogenicity Of Hexyon®supporting

confidence: 56%

“…Primary series consisted of three vaccine doses administered at age 2, 4, and 6 months (standard schedule; Latin America, Asia) [7, 10, 11, 18–21], 2, 3, and 4 months (‘accelerated’ schedule; Europe) [8, 9, 12] or 6, 10, and 14 weeks (expanded program of immunization schedule; South Africa, India) [Table 1] [13, 17]. The booster dose was administered at 11–24 months [Table 3] [6, 8–10, 21, 23].…”

Section: Immunogenicity Of Hexyon®mentioning

confidence: 99%

“…The immunogenicity of Hexyon ® primary series has been compared with that of a pentavalent vaccine, Pentaxim ® (DTaP-IPV liquid suspension used to reconstitute freeze-dried Hib), co-administered with a monovalent HB vaccine (Engerix B ® , Euvax B ® or Engerix B™ Pediatrico) in three trials (A3L10 [9], A3L31 [11] and A3L02 [18]). Participants in A3L31 had received HB vaccination at birth while those in A3L10 and A3L02 had not.…”

Section: Immunogenicity Of Hexyon®mentioning

confidence: 99%

“…Participants in A3L31 had received HB vaccination at birth while those in A3L10 and A3L02 had not. All study vaccines were administered according to the standard [11, 18] or accelerated [9] schedule, with the exception of Euvax B ® which was administered only at age 1 and 6 months [11]. A3L10 was followed by a booster study in which all eligible subjects received Hexyon ® booster at age 15–18 months [9].…”

Section: Immunogenicity Of Hexyon®mentioning

confidence: 99%

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DTaP-IPV-HepB-Hib Vaccine (Hexyon®): An Updated Review of its Use in Primary and Booster Vaccination

Syed

2019

Pediatr Drugs

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Hexyon ® is a fully-liquid, ready-to-use, hexavalent vaccine approved in the EU since 2013 for primary and booster vaccination in infants and toddlers from age 6 weeks against diphtheria, tetanus, pertussis, hepatitis B (HB), poliomyelitis, and invasive diseases caused by Haemophilus influenzae type b (Hib). While the source of HB antigen in Hexyon ® is different from other vaccines, the rest of its valences have been extensively used in other approved vaccines. Hexyon ® is highly immunogenic for all its component toxoids/antigens when used as primary and booster vaccine in infants and toddlers, irrespective of vaccination schedule. It provides durable protection against hepatitis B. Hexyon ® can be used for a mixed primary series of hexavalent-pentavalent-hexavalent vaccines or as a booster in infants primed with Infanrix hexa™ or pentavalent (whole-cell or acellular pertussis) vaccines. Coadministration of Hexyon ® with other common childhood vaccines did not affect immune response to any vaccines. Hexyon ® has a good reactogenicity/safety profile. The immunogenicity and safety profile of Hexyon ® was similar to that of several approved vaccines, including Infanrix hexa™. However, Hexyon ® offers the convenience of full-liquid, ready-to-use formulation, which may minimize vaccination errors and preparation time. Thus, Hexyon ® is a convenient, useful option for vaccination against childhood diseases caused by six major pathogens.

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Section: Immunogenicity Of Hexyon®supporting

confidence: 56%

Section: Immunogenicity Of Hexyon®mentioning

confidence: 99%

Section: Immunogenicity Of Hexyon®mentioning

confidence: 99%

Section: Immunogenicity Of Hexyon®mentioning

confidence: 99%

See 2 more Smart Citations

DTaP-IPV-HepB-Hib Vaccine (Hexyon®): An Updated Review of its Use in Primary and Booster Vaccination

Syed

2019

Pediatr Drugs

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“…), как и можно было ожидать, анти-HBs были выше во второй группе (получившей 4 дозы вакцины против гепатита В) в сравнении с первой (получившей 3 дозы вакцины против гепатита В). При этом профиль безопасности и реактогенности при обоих графиках вакцинации был сходными [28].…”

Section: частота не ожидаемых нежелательных явлений в течение 30 сут unclassified

Safety and Immunogenicity of Fully Liquid Hexavalent DTaP-IPV-HepB-Hib Vaccine in Healthy Infants in Russian Federation

Намазова-Баранова

Харит

Перминова³

et al. 2019

Epidemiology and Vaccinal Prevention

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Авторы благодарят персонал исследовательских центров за помощь в проведении исследования, а также детей и их родителей за их участие в исследовании. Авторы также благодарят сотрудников лаборатории GCI, включая д-ра Хавьера Да Косту (Санофи Пастер) за проведение серологического анализа и рецензирование рукописи статьи. Рукопись статьи была подготовлена с помощью профессионального составителя медицинских текстов д-ра Эндрю Лэйна (компания Lane Medical Writing) в соответствии с рекомендациями Европейской ассоциации составителей медицинских текстов и Правилами надлежащей практики публикаций.

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Post-Marketing Safety Surveillance of a Childhood Pentavalent Diphtheria–Tetanus–Acellular Pertussis–Polio and Haemophilus influenzae Type B (DTaP-IPV//Hib) Vaccine in South Korea

et al. 2022

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Introduction PENTAXIM™ (Sanofi), DTaP-IPV//Hib, a pentavalent combination vaccine for protection against diphtheria, tetanus, pertussis, poliomyelitis, and invasive infections caused by Haemophilus influenzae type b, has been licensed in South Korea by the Ministry of Food and Drug Safety (MFDS) on May 9, 2016, and is currently used in routine vaccination. The aim of this phase IV study, conducted as a post-licensure commitment in South Korea, was to evaluate the safety of the DTaP-IPV//Hib vaccine when administered in infants at 2, 4, and 6 months of age in the real-world clinical practice. Methods This multicenter, observational, post-marketing surveillance (PMS) study was conducted in real-world practice in South Korea. Infants aged 2 months or older were enrolled across seven centers from July 31, 2018 to February 11, 2020. The study outcomes included occurrence, time to onset, duration, intensity, and causality assessment (for unsolicited adverse events [AEs] only) for several pre-listed solicited injection-site and systemic reactions, unsolicited AEs, and serious adverse events (SAEs). Results Data from 619 participants were included in the safety analysis. Overall, 618 AEs were reported by 273 (44.1%) participants consisting of 121 solicited injection-site reactions (15.4%), 344 solicited systemic reactions (24.6%), and 153 unsolicited AEs (15.7%) of which, 124 were unexpected AEs (12.9%) (regardless of intensity). None of the unsolicited AEs were reported to have a causal relationship with the study vaccine. One SAE of pyrexia (solicited reaction) was reported. Most AEs were of mild intensity, and all participants recovered. Conclusion This PMS study of the DTaP-IPV//Hib vaccine confirmed its safety profile in a real-life setting in South Korea and justified that the vaccine is well tolerated when used in infants aged 2 months or older for the primary series.

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Immunogenicity and safety of a fully liquid DTaP-IPV-HB-PRP∼T hexavalent vaccine compared with the standard of care in infants in the Republic of Korea

Cited by 13 publications

References 21 publications

DTaP-IPV-HepB-Hib Vaccine (Hexyon®): An Updated Review of its Use in Primary and Booster Vaccination

DTaP-IPV-HepB-Hib Vaccine (Hexyon®): An Updated Review of its Use in Primary and Booster Vaccination

Safety and Immunogenicity of Fully Liquid Hexavalent DTaP-IPV-HepB-Hib Vaccine in Healthy Infants in Russian Federation

Post-Marketing Safety Surveillance of a Childhood Pentavalent Diphtheria–Tetanus–Acellular Pertussis–Polio and Haemophilus influenzae Type B (DTaP-IPV//Hib) Vaccine in South Korea

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