Immunogenicity and safety of a DTaP-IPV/Hib pentavalent vaccine given as primary and booster vaccinations in healthy infants and toddlers in Japan.
J Infect Chemother
; 26(7): 651-659, 2020 Jul.
Article
en En
| MEDLINE
| ID: mdl-32307307
ABSTRACT
BACKGROUND:
Globally, the use of single DTaP-IPV/Hib vaccines that combine DTaP-IPV and Hib is widespread, but in Japan vaccination is usually concomitant at separate sites. The immunogenicity and safety of a primary vaccination series and booster of a combined pentavalent DTaP-IPV/Hib vaccine were evaluated and compared to separate administration of DTaP-IPV and Hib in Japanese infants.METHODS:
Healthy Japanese infants were administered DTaP-IPV/Hib (Group A N = 207) or DTaP-IPV + Hib (Group B N = 207) by the subcutaneous (SC) or DTaP-IPV/Hib by the intramuscular (IM) route (Group C N = 10). All subjects received a 3-dose primary vaccination series and a booster. Non-inferiority (Group A versus Group B) was tested post-primary series and subsequent post hoc analyses were performed for anti-Hib. Safety was assessed by parental reports.RESULTS:
Non-inferiority for SC administration of Group A versus Group B for the primary series was demonstrated for antibody responses to all antigens except Hib using the threshold of 1.0 µg/mL. Post hoc analyses for anti-Hib demonstrated non-inferiority for the primary series response using 0.15 µg/mL, and for pre-booster antibody persistence and the booster response using 0.15 µg/mL and 1.0 µg/mL. The immune response was similar for each antigen following SC or IM administration. There were no safety concerns in any group, and a lower incidence of injection sites for the IM route was observed as expected.CONCLUSIONS:
These data show the good immunogenicity and safety profile of the DTaP-IPV/Hib vaccine as a 3-dose infant primary series followed by a booster in the second year of life in Japan.Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Vacuna Antipolio de Virus Inactivados
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Vacuna contra Difteria, Tétanos y Tos Ferina
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Inmunización Secundaria
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Cápsulas Bacterianas
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Vacunas contra Haemophilus
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Vacunas contra Difteria, Tétanos y Tos Ferina Acelular
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Inmunogenicidad Vacunal
Tipo de estudio:
Clinical_trials
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Incidence_studies
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Prognostic_studies
País/Región como asunto:
Asia
Idioma:
En
Revista:
J Infect Chemother
Asunto de la revista:
MICROBIOLOGIA
/
TERAPIA POR MEDICAMENTOS
Año:
2020
Tipo del documento:
Article
País de afiliación:
Japón