A Phase III Randomized, Double-blind, Clinical Trial of an Investigational Hexavalent Vaccine Given at Two, Three, Four and Twelve Months

Abstract

The safety and immunogenicity of DTaP5-HB-IPV-Hib is comparable to Control when administered in the 2-month, 3-month, 4-month 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.

Hepatitis B and pertussis antibodies in 4- to 5-year-old children previously vaccinated with different hexavalent vaccines

“…The clinical portion of this study was conducted in Finland from late April to early August 2016, as an extension of 2 European pivotal studies: a study evaluating a 3 + 1 schedule conducted in Belgium, Finland, and Germany from late May 2011 to mid-March 2013 (NCT01341639) 13 and a study evaluating a 2 + 1 schedule conducted in Finland, Italy, and Sweden from late November 2011 to early October 2013 (NCT01480258). 14 In these randomized, double-blind trials, infants received either a 3-dose primary series of DTaP5-HB-IPV-Hib or DTaP3-HB-IPV/Hib at 2, 3, and 4 months of age and a toddler dose at 12 months of age or a 2 dose primary series of DTaP5-HB-IPV-Hib or DTaP3-HB-IPV/Hib at 2 and 4 months of age and a toddler dose at 11 to 12 months of age.…”

Hexavalent vaccines in infants: a systematic literature review and meta-analysis of the solicited local and systemic adverse reactions of two hexavalent vaccines

“…The remaining nine articles reported results from eleven RCTs. Only two RCTs with DT5aP-HBV-IPV-Hib were identified and subsequently excluded from data extraction as per the pre-specified threshold of three RCTs that were needed for performing the meta-analysis [19,20]. It is noteworthy that differences in schedule and co-administered vaccines in those two RCTs limited the value of their pooling for meta-analysis.…”

“…The DT3aP-HBV-IPV-Hib vaccine has been assessed through clinical studies totaling more than 40,000 infants [10,13]. Although different in their composition, the immune response of DT2aP-HBV-IPV-Hib and DT5aP-HBV-IPV-Hib against the antigens common to the vaccines was assessed by demonstration of their non-inferiority to DT3aP-HBV-IPV-Hib but safety comparisons were exploratory [14][15][16][17][18][19][20][21]. However, despite a recognized trend toward higher frequency of local reactions and fever being reported for DT2aP-HBV-IPV-Hib compared with DT3aP-HBV-IPV-Hib, results from individual studies convey the conclusion that both vaccines have comparable safety profiles and no significant differences in tolerability [11].…”

Recommendation for use of diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, Haemophilus influenzae type b conjugate, and hepatitis B vaccine in infants

“…It is highly immunogenic compared to licensed comparators. [15][16][17][18][19][20] A phase III non-inferiority study evaluated the immunogenicity of DTaP-IPV-Hib-HepB vaccine in >300 Korean infants. 19) The immunologic responses were compared between two groups: infants vaccinated with HepB vaccine alone at birth and hexavalent vaccine at 2, 4, and 6 months of age (Group 1); and infants vaccinated with a standalone HepB vaccine at birth and at 1 and 6 months of age and a pentavalent vaccine (DTaP-IPV/Hib) at 2, 4, and 6 months of age (Group 2).…”