Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib and PHiD-CV When Coadministered With MenACWY-TT in Infants: Results of an Open, Randomized Trial.
| Autor: | Merino Arribas JM; From the Pediatric Department, Hospital Universitario de Burgos, Burgos, Spain., Carmona Martínez A; Instituto Hispalense de Pediatria, Edificio Expolocal, Sevilla, Spain., Horn M; Pediatric Office Dr. Horn, Schoenau, Germany., Perez Porcuna XM; Manlleu Primary Care Center, Manlleu Spain., Otero Reigada MDC; Pediatrics Department, Hospital La Fe, Valencia, Spain., Marès Bermúdez J; Institut Pediàtric Marès - Riera, Blanes, Spain., Centeno Malfaz F; Pediatrics Department, Rio Hortega University Hospital, Valladolid, Spain., Miranda M; Pediatrics Department, Hospital de Antequera, Antequera, Spain., Mendez M; Pediatric Hospital Germans Trias i Pujol, Badalona, Spain., Garcia Cabezas MA; Hospital General Universitario de Ciudad Real, Ciudad Real, Spain., Christoph W; Study Center Weilheim, Pediatric Practice Weilheim, Weilheim i.OB, Germany., Bleckmann G; Private Practice Bleckmann, Baunatal, Germany., Fischbach T; Private Practice Fischbach, North-Rhine, Solingen, Germany., Kolhe D; Novo Nordisk India, EPIP Area, Vijayanagar, KIADB Export Promotion Industrial Area, Whitefield, Bengaluru, Karnataka, India., Van der Wielen M; GSK, Wavre, Belgium., Baine Y; Yaela Baine Consulting, Merion, PA. |
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| Jazyk: | angličtina |
| Zdroj: | The Pediatric infectious disease journal [Pediatr Infect Dis J] 2018 Jul; Vol. 37 (7), pp. 704-714. |
| DOI: | 10.1097/INF.0000000000002061 |
| Abstrakt: | 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 μg/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. |
| Databáze: | MEDLINE |
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