A Phase III Randomized, Double-Blind, Clinical Trial of an Investigational Hexavalent Vaccine Given at 2, 3, 4, and 12 Months.

Combination vaccines simplify vaccination visits and improve coverage and timeliness. DTaP5-HB-IPV-Hib is a new investigational, fully-liquid, combination vaccine containing a 5-antigen pertussis component and which is designed to protect against 6 infectious diseases.,In this multicenter, double-blind, comparator-controlled, Phase III study (NCT01341639) conducted in Finland, Germany, and Belgium, healthy infants were randomized 1:1 to receive one of two immunization regimens. The DTaP5-HB-IPV-Hib Group received the investigational hexavalent vaccine (DTaP-HB-IPV-Hib) and the Control Group received Infanrix-hexa (DTPa3-HBV-IPV/Hib) at 2, 3, 4 and 12 months of age. Both groups received concomitantly Prevnar 13 (PCV13) and Rotateq (RV5) at 2, 3, 4 months of age and ProqQad (MMRV) at 12 months. MMRV was also administered to all Study subjects at 13 months of age.,A total of 628 subjects in the DTaP5-HB-IPV-Hib Group and 622 subjects in the Control Group were randomized. In a per-protocol analysis, immune responses to vaccine antigens 1 month after dose 3 and after the toddler dose were non-inferior in the DTaP5-HB-IPV-Hib Group as compared to the Control Group. The DTaP5-HB-IPV-Hib Group responses to MMRV given concomitantly at 12 months were all non-inferior compared to the Control Group.Solicited adverse event (AE) rates after any dose, including fever, were similar in both groups. Most AEs were mild-to-moderate and did not lead to subject withdrawal. Vaccine-related serious adverse events occurred infrequently in the DTaP5-HB-IPV-Hib Group (0.3%) and the Control Group (0.2%).,The safety and immunogenicity of DTaP5-HB-IPV-Hib is comparable to Control when administered in the 2, 3, 4 and 12 month schedule. DTaP5-HB-IPV-Hib has the potential to provide a new hexavalent option for pediatric combination vaccines, aligned with recommended immunizations in Europe.