Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib and PHiD-CV When Coadministered With MenACWY-TT in Infants

Arribas, J.M. Merino; Martinez, Alfonso Carmona; Horn, Michael; Porcuna, Xavier M. Pérez; Reigada, María del Carmen Otero; Bermúdez, Josep Marès; Centeno, Fernando; Miranda, Mariano; Méndez, María José; Cabezas, Miguel Ángel García; Wittermann, Christoph; Bleckmann, Gerhard; Fischbach, Thomas; Kolhe, Devayani; Wielen, Marie Van der; Baine, Yaela

doi:10.1097/inf.0000000000002061

Cited by 3 publications

(11 citation statements)

References 34 publications

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“…Four studies have assessed the safety and immunogenicity of MenACWY-TT in infants (Table 1) [28][29][30][31][32]. All studies were performed in healthy infants who had received routinely recommended vaccines and did not have a history of disease targeted by the vaccines administered; infants who had received vaccines other than those expected to be administered within 1 month before enrollment were excluded.…”

Section: Review Of Menacwy-tt Studies Performed In Infantsmentioning

confidence: 99%

“…In Study 4, booster and vaccine responses were evaluated using rSBA titers ≥1:32 and hSBA titers ≥1:8 cutoffs (for seronegative subjects) or an increase of ≥4-fold (for seropositive subjects) [28]. Two studies evaluated immune responses to concomitantly administered vaccines in addition to that of MenACWY-TT [28,31,32]. Safety and reactogenicity were also evaluated in each study.…”

Section: Review Of Menacwy-tt Studies Performed In Infantsmentioning

confidence: 99%

“…All subjects also received a booster dose of the assigned vaccine at 12 months of age. An important aspect of this study was evaluation of immune responses of other vaccines routinely administered to young infants; as such, all subjects also received diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus and Haemophilus influenzae type b vaccine (DTPa-HBV-IPV/Hib) and 10-valent pneumococcal conjugate vaccine (PCV10) at 2, 3, 4, and 12 months of age [32]. Primary objectives were to demonstrate the noninferiority of 2-and 3-dose primary schedules of MenACWY-TT to MenC-CRM 197 and MenC-TT for serogroup C, and immunogenicity of both MenACWY-TT regimens for serogroups A, W, and Y, as measured by percentages of participants with rSBA titers ≥1:8 [31].…”

Section: Overviews Of Individual Studiesmentioning

confidence: 99%

“…Secondary immunogenicity objectives relating to MenACWY-TT included additional evaluations of immune responses in rSBA and hSBA, as well as safety and reactogenicity, which were evaluated similarly to Study 1. Additional secondary objectives were assessments of the immunogenicity of DTPa-HBV-IPV/Hib and PCV10 when coadministered with MenACWY-TT [32].…”

Section: Overviews Of Individual Studiesmentioning

confidence: 99%

“…As previously described, both Studies 3 and 4 evaluated immune responses to infant vaccines administered concomitantly with MenACWY-TT [28,32]. Immune responses to DTPa, IPV, Hib, and PCV10 were evaluated in both studies.…”

Section: Immunogenicity Of Concomitantly Administered Vaccinesmentioning

confidence: 99%

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Protecting the most vulnerable age group: a review of MenACWY-TT immunogenicity and safety in infants

Martinón-Torres

Serra

Sáfadi

2020

Expert Review of Vaccines

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Introduction: Neisseria meningitidis causes invasive meningococcal disease (IMD), with the highest incidence observed in infants and young children. Meningococcal serogroups A, B, C, W, X, and Y account for almost all IMD cases worldwide. Available meningococcal vaccines targeting serogroups A, C, W, and Y (MenACWY) include those conjugated to diphtheria toxoid (MenACWY-D), diphtheria protein cross-reactive material 197 (MenACWY-CRM 197 ), and tetanus toxoid (MenACWY-TT). MenACWY-TT is indicated for use starting at 6 weeks of age. Areas covered: This review discusses data from the four primary studies assessing MenACWY-TT safety and immunogenicity in infants, which evaluated a variety of dosing schedules, short-term and longterm outcomes, and impact of coadministration on the immunogenicity of routine childhood vaccines. Remaining gaps in the field are addressed. Expert opinion: Robust data support the use of MenACWY-TT in infants starting as early as 6 weeks of age. MenACWY-TT was safe and well tolerated in infants, was immunogenic after priming and booster, and demonstrated persistent immunogenicity. Lower persistence for serogroup A relative to other serogroups based on serum bactericidal assays (SBAs) using human complement appears to be a class effect of MenACWY conjugate vaccines. Correlates of protection other than SBA are being explored, including immunologic responses associated with different carrier proteins. ARTICLE HISTORY

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Section: Review Of Menacwy-tt Studies Performed In Infantsmentioning

confidence: 99%

Section: Review Of Menacwy-tt Studies Performed In Infantsmentioning

confidence: 99%

Section: Overviews Of Individual Studiesmentioning

confidence: 99%

Section: Overviews Of Individual Studiesmentioning

confidence: 99%

Section: Immunogenicity Of Concomitantly Administered Vaccinesmentioning

confidence: 99%

See 3 more Smart Citations

Protecting the most vulnerable age group: a review of MenACWY-TT immunogenicity and safety in infants

Martinón-Torres

Serra

Sáfadi

2020

Expert Review of Vaccines

View full text Add to dashboard Cite

show abstract

Infant vaccine co-administration: review of 18 years of experience with GSK’s hexavalent vaccine co-administered with routine childhood vaccines

Dolhain

Janssens

Dindore

et al. 2020

Expert Review of Vaccines

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Immunogenicity and Safety of Meningococcal Group A, C, W and Y Tetanus Toxoid Conjugate Vaccine: Review of Clinical and Real-World Evidence

Findlow

Knuf

2019

Future Microbiol.

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Protection by meningococcal group A, C, W and Y (MenACWY) vaccines against four meningococcal disease-causing serogroups is increasingly important because of changing epidemiologic patterns of meningococcal disease, including recent meningococcal serogroup W outbreaks/disease clusters. The MenACWY vaccine conjugated to tetanus toxoid (MenACWY-TT) has been extensively evaluated across the age spectrum (age ≥6 weeks) in randomized Phase II and III and in postmarketing studies. Results support the robust immunogenicity of MenACWY-TT across ages and coadministration with other vaccines. The safety profile is similar regardless of age, primary versus booster vaccination, or concomitant administration; local (swelling, pain, redness) and systemic (fever, fatigue, headache, drowsiness, loss of appetite, irritability) reactogenicity events are most common. These data support use of MenACWY-TT to protect against MenACWY disease.

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Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib and PHiD-CV When Coadministered With MenACWY-TT in Infants

Abstract: Primary and booster vaccinations of infants/toddlers with DTPa-HBV-IPV/Hib and PHiD-CV coadministered with MenACWY-TT were immunogenic with clinically acceptable reactogenicity profiles. These results support the coadministration of MenACWY-TT with routine childhood vaccines.

Cited by 3 publications

References 34 publications

Protecting the most vulnerable age group: a review of MenACWY-TT immunogenicity and safety in infants

Protecting the most vulnerable age group: a review of MenACWY-TT immunogenicity and safety in infants

Infant vaccine co-administration: review of 18 years of experience with GSK’s hexavalent vaccine co-administered with routine childhood vaccines

Immunogenicity and Safety of Meningococcal Group A, C, W and Y Tetanus Toxoid Conjugate Vaccine: Review of Clinical and Real-World Evidence

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