Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

New Infant Vaccine Treats 6 Diseases

A closer look at safety & tolerability

The safety and immunogenicity of DTaP5-IPV-Hib-HepB fully liquid investigational hexavalent vaccine are comparable with the analogous licensed component vaccines and provide a new combination vaccine option aligned with the recommended US infant immunization schedule, according to a phase-III study of 1,465 participants. Overall, 981 healthy infants were vaccinated in group 1 with the hexavalent vaccine and 484 in group 2 with the analogous licensed component vaccines.

The study found:

• Immune responses in group 1 to all antigens contained in the vaccine 1 month after dose 3 were essentially noninferior to those in group 2.

• Adverse event rates after any dose were similar in both groups.

Citation: Marshall GS, Adams GL, Leonardi ML, et al. Immunogenicity, safety, and tolerability of a hexavalent vaccine in infants. Pediatrics. 2015: 136(2):323-332.

Commentary: Vaccine administration has led to making many diseases, including Haemophilus influenzae type b, polio, and measles quite rare. As we have recently seen with resurgence of measles, continued vigilance and high immunization rates are important in making sure that these diseases remain rare. The development of a hexavalent vaccine is another step in making immunization easier for clinicians to administer and for patients to accept. —Neil Skolnik, MD