Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib and PHiD-CV When Coadministered With MenACWY-TT in Infants: Results of an Open, Randomized Trial
Por:
Arribas, JMM, Martinez, AC, Horn, M, Porcuna, XMP, Reigada, MDO, Bermudez, JM, Malfaz, FC, Miranda, M, Mendez, M, Cabezas, MAG, Christoph, W, Bleckmann, G, Fischbach, T, Kolhe, D, Van der Wielen, M and Baine, Y
Publicada:
1 jul 2018
Resumen:
Background: This study evaluated the immunogenicity and reactogenicity of a combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus virus-Haemophilus influenzae type b vaccine (DTPa-HBV-IPV/Hib) and a 10-valent pneumococcal conjugate vaccine (PHiD-CV) coadministered with a quadrivalent meningococcal conjugate vaccine (MenACWY-TT) in infants/toddlers.
Methods: In this open, controlled, phase III study (NCT01144663), 2095 healthy infants were randomized (1:1:1:1) into 4 groups to receive MenACWY-TT at 2, 3, 4 and 12 months of age or MenACWY-TT, MenC-CRM197, or MenC-TT at 2, 4 and 12 months of age. All participants received PHiD-CV and DTPa-HBV-IPV/Hib at 2, 3, 4 and 12 months of age. Immunogenicity of DTPa-HBV-IPV/Hib was evaluated in exclusive randomized subsets of 25% of participants from each group postprimary, prebooster and postbooster vaccination, whereas immunogenicity of PHiD-CV was evaluated at all time points. Reactogenicity was evaluated on the total vaccinated cohorts during 8 days after each vaccination.
Results: For each DTPa-HBV-IPV/Hib antigen, 97.2%, 76.5% and 97.9% of participants had seropositive/seroprotective levels 1 month postprimary vaccination, before the booster dose and 1 month postbooster, respectively. For each vaccine pneumococcal serotype, 74.0% of infants had antibody concentrations 0.35 g/mL at 1 month postprimary vaccination, and robust increases in antibody geometric mean concentrations were observed from prebooster to postbooster. Redness was the most frequent solicited local symptom at the DTPa-HBV-IPV/Hib and PHiD-CV injection sites, reported after up to 47.7% and 57.0% of doses postprimary and postbooster vaccination, respectively.
Conclusions: 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.
Filiaciones:
Arribas, JMM:
Hosp Univ Burgos, Pediat Dept, Burgos, Spain
Martinez, AC:
Edificio Expolocal, Inst Hispalense Pediat, Seville, Spain
Horn, M:
Pediat Off Dr Horn, Schoenau, Germany
Porcuna, XMP:
Manlleu Primary Care Ctr, Manlleu, Spain
Reigada, MDO:
Hosp La Fe, Pediat Dept, Valencia, Spain
Malfaz, FC:
Rio Hortega Univ, Pediat Dept, Valladolid, Spain
Miranda, M:
Hosp Antequera, Pediat Dept, Antequera, Spain
:
Pediat Hosp Germans Trias & Pujol, Badalona, Spain
Cabezas, MAG:
Hosp Gen Univ Ciudad Real, Ciudad Real, Spain
Christoph, W:
Study Ctr Weilheim, Pediat Practice Weilheim, Weilheim, Germany
Bleckmann, G:
Private Practice Bleckmann, Baunatal, Germany
Kolhe, D:
Novo Nordisk India, EPIP Area, Bengaluru, Karnataka, India
Van der Wielen, M:
GSK, Ave Fleming 20, B-1300 Wavre, Belgium
Baine, Y:
Yaela Baine Consulting, Merion, PA USA
Bronze
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