Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib and PHiD-CV When Coadministered With MenACWY-TT in Infants: Results of an Open, Randomized Trial. Issue 7 (July 2018)

• Record Type: Journal Article
• Authors: Merino Arribas, Jose Manuel; Carmona Martínez, Alfonso; Horn, Michael; Perez Porcuna, Xavier Maria; Otero Reigada, Maria del Carmen; Marès Bermúdez, Josep; Centeno Malfaz, Fernando; Miranda, Mariano; Mendez, Maria; Garcia Cabezas, Miguel Angel; Christoph, Wittermann; Bleckmann, Gerhard; Fischbach, Thomas; Kolhe, Devayani; Van der Wielen, Marie; Baine, Yaela
• Is Part Of: Pediatric infectious disease journal. Volume 37:Issue 7(2018)
• Publication Date: 2018-07
• Subjects: DTPa-HBV-IPV/Hib -- 10-valent pneumococcal conjugate vaccine -- quadrivalent meningococcal conjugate vaccine -- immunogenicity -- reactogenicity; Communicable diseases in children -- Periodicals; Infection in children -- Periodicals; 618.929
• DOI: 10.1097/INF.0000000000002061
• Languages: English
• ISSNs: 0891-3668

Abstract

Abstract : 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. Abstract : Supplemental Digital Content is available in the text.