A fully liquid DTaP-IPV-Hep B-PRP-T hexavalent vaccine for primary and booster vaccination of healthy Mexican children

Aquino, Amalia Guadalupe Becerra; Brito, Maricruz Gutiérrez; Doniz, Carlos E. Aranza; Herrera, Juan Francisco Galán; Macías, M.; Zambrano, Betzana; Plennevaux, Eric; Santos-Lima, Eduardo

doi:10.1016/j.vaccine.2012.07.040

Cited by 34 publications

(58 citation statements)

References 26 publications

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“…In previous studies, the investigational DTaP-IPV-HB-PRP-T vaccine has been shown to be safe and immunogenic when administered in a 3-dose primary series schedule at 2, 4, and 6 months (7) and 6, 10, and 14 weeks (10), with or without the administration of a standalone HB vaccine at birth (10)(11)(12)(13). Additionally, a booster dose in the second year of life has been shown to be safe and to elicit an anamnestic response irrespective of HB vaccination at birth (11,14).…”

Section: Introductionmentioning

confidence: 99%

“…Additionally, a booster dose in the second year of life has been shown to be safe and to elicit an anamnestic response irrespective of HB vaccination at birth (11,14).…”

Section: Introductionmentioning

confidence: 99%

“…As part of an extensive clinical development plan conducted largely outside Europe (Central America (11), South America (8,13,15,16), Thailand (12), and South Africa (10,14), and prior to the approval of this vaccine by the European Medicines Agency in 2013 via the Centralised Procedure (17), the present study was performed in Turkey to evaluate the performance of the vaccine when used with a 2, 3, 4 month infant primary series versus control vaccines (without a HB vaccination at birth) and also to assess the immunogenicity before and after a toddler booster dose of the investigational vaccine in the second year of life. This corresponded to the infant DTaP vaccination schedule in use in Turkey at the time of the study.…”

Section: Introductionmentioning

confidence: 99%

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A fully liquid DTaP-IPV-HB-PRP-T hexavalent vaccine for primaryand booster vaccination of healthy Turkish infants and toddlers*

Ceyhan¹,

Yıldırım²,

Tezer³

et al. 2017

Turk J Med Sci

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Background/aim: Immunogenicity and safety of a primary series of a fully liquid, hexavalent DTaP-IPV-HB-PRP-T vaccine given at 2, 3, and 4 months of age compared to licensed comparators and a DTaP-IPV-HB-PRP-T booster at 15-18 months were evaluated. Materials and methods: This was a Phase III, randomized, open-label trial. Primary series (no hepatitis B [HB] at birth) of DTaP-IPV-HB-PRP-T (N = 155) (group 1) or licensed control vaccines (DTaP-IPV//PRP-T and standalone HB: N = 155) (group 2) and DTaP-IPV-HB-PRP-T booster were administered. Noninferiority was evaluated 1 month postprimary series for anti-HB seroprotection (SP). All other analyses were descriptive. Safety was assessed from parental reports.Results: Postprimary series noninferiority of anti-HB ≥ 10 mIU/mL was demonstrated for the DTaP-IPV-HB-PRP-T vaccine (94.0%) compared to the licensed control (96.1%). Postprimary series primary SP and seroconversion (SC) rates were high and similar for both groups. Antibody persistence (prebooster) was high for each antigen and similar between groups except for HB, which was lower for DTaP-IPV-HB-PRP-T than for standalone HB. For each antigen except HB, DTaP-IPV-HB-PRP-T booster responses were high and similar in each group. Safety was good for primary and booster series and similar between groups. Conclusion:The DTaP-IPV-HB-PRP-T vaccine is immunogenic and safe when administered in a challenging primary series schedule without HB vaccination at birth.

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Section: Introductionmentioning

confidence: 99%

“…Additionally, a booster dose in the second year of life has been shown to be safe and to elicit an anamnestic response irrespective of HB vaccination at birth (11,14).…”

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

A fully liquid DTaP-IPV-HB-PRP-T hexavalent vaccine for primaryand booster vaccination of healthy Turkish infants and toddlers*

Ceyhan¹,

Yıldırım²,

Tezer³

et al. 2017

Turk J Med Sci

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show abstract

“…Moreover, seroprotective levels against P1, P2, P3 and Hib were reached in ≥98%, ≥95%, ≥97 and ≥91% of cases, respectively . Although there is a limit to the absence of PRN, seroconversion rates for acellular pertussis antigens were ≥90% for PT and ≥82% for FHA . After the booster dose, seroprotection rates with Hexyon were consistently 100% for P1, P2, P3 and Hib .…”

Section: Hexyonmentioning

confidence: 93%

Hexavalent vaccines for immunization in paediatric age

Esposito

Tagliabue

Bosis

et al. 2014

Clinical Microbiology and Infection

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Despite the potential for protection against a broad spectrum of pathogens, the availability of an increased number of effective vaccines could lead to a significant reduction in vaccination coverage as the result of issues with implementation of new vaccines within existing protocols. To overcome these problems, the development of combined vaccines has been promoted. The use of combined vaccines offers a number of potential benefits, including a reduction in the number of patient visits, reduced complications associated with multiple intramuscular injections, decreased costs of stocking and administering separate vaccines, and a lowering of the risk of delayed or missed vaccinations. The hexavalent vaccine includes antigens against diphtheria, tetanus, acellular pertussis (DTaP), hepatitis B (HBsAg), poliomyelitis (P1, P2, P3) and Haemophilus influenzae type B (Hib) infections. The primary goal of this review is to discuss the immunogenicity, efficacy, safety and tolerability of several hexavalent preparations that are either commercially available or still under development.

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“…Por su parte, las vacunas combinadas ofrecen, con una sola administración, protección frente a un mayor número de enfermedades, lo que favorece el cumplimiento del calendario de vacunación, y además obtienen una mayor aceptación entre los padres por la disminución del número de pinchazos y la simplificación de la pauta 27,28 . Existen 2 vacunas hexavalentes combinadas comercializas en España (Infanrix Hexa ® y Hexyon ® ), y ambas ofrecen una buena inmunogenicidad, eficacia y tolerabilidad frente a los antígenos que contienen: difteria (D), tétanos (T), tos ferina acelular (Pa), HB, polio inactivada (VPI) y Haemophilus influenzae b (Hib) [29][30][31][32] .…”

Section: Vacunas Monovalentes Y Combinadas De Hepatitis Bunclassified

Vacunación frente a la hepatitisB. Impacto de los programas de vacunación tras 20años de su utilización en España. ¿Es tiempo de cambios?

Fernández¹,

Díez‐Domingo²,

Bermúdez³

et al. 2015

Enfermedades Infecciosas y Microbiología Clínica

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A fully liquid DTaP-IPV-Hep B-PRP-T hexavalent vaccine for primary and booster vaccination of healthy Mexican children

Cited by 34 publications

References 26 publications

A fully liquid DTaP-IPV-HB-PRP-T hexavalent vaccine for primaryand booster vaccination of healthy Turkish infants and toddlers*

A fully liquid DTaP-IPV-HB-PRP-T hexavalent vaccine for primaryand booster vaccination of healthy Turkish infants and toddlers*

Hexavalent vaccines for immunization in paediatric age

Vacunación frente a la hepatitisB. Impacto de los programas de vacunación tras 20años de su utilización en España. ¿Es tiempo de cambios?

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