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Investigational hexavalent vaccine safe, effective when given with RotaTeq, Prevnar 13

WASHINGTON — An investigational combination hexavalent vaccine for protection against diphtheria, tetanus, pertussis, poliovirus, Haemophilus influenzae type b and hepatitis B was found noninferior to the current protection regimen when concomitantly administered with RotaTeq and Prevnar 13, according to data presented at the 2015 AAP National Conference and Exhibition.

“This hexavalent vaccine demonstrated robust immunogenicity and an acceptable safety profile in over 3,500 infants,” Stanley L. Block, MD, FAAP, of the Kentucky Pediatric/Adult Research group, said during his presentation. “Combination vaccines improve vaccination compliance and timeliness, while reducing the number of vaccines that get mixed up or administered to the wrong patient, and help all office logistics.”

Stanley L. Block

In two phase 3 studies, the researchers randomly administered vaccines to 4,281 infants at ages 2, 4, 6 and 15 months. The study population was divided evenly; one group received the investigational hexavalent vaccine, RotaTeq (rotavirus vaccine, Merck) and Prevnar 13 (13-valent pneumococcal conjugate vaccine, Pfizer), and the control group received licensed component vaccines. The investigational group received three doses of hexavalent vaccine at ages 2, 4 and 6 months and an additional dose of pentavalent DTaP vaccine (DTaP5) at age 15 months. Seroconversion rates and geometric mean concentrations of antigens were measured and compared between groups.

There were 3,986 infants who received the first three doses of hexavalent vaccine, with 3,593 of those infants having received the 15-month DTaP5 dose. Results showed that at 1 month after the third dose of hexavalent vaccine, the geometric mean concentrations of antigens were statistically similar in both study groups except for the filamentous hemagglutinin antigen, which is a component of the pertussis protection. The seroconversion rate of all antigens in the hexavalent vaccine group, including FHA, was noninferior to the control group.

The researchers said that all infants in the investigational group who received the 15-month dose of DTaP5 had pertussis immune responses rates that were noninferior to the control infants.

The safety profile for the hexavalent vaccine was similar to the component vaccine regimen, with almost no statistically significant differences in the frequency of adverse events. Cases of mild to moderate fever, however, were greater in the hexavalent group (49.1% vs 35.6%).

According to Block, six deaths occurred in the investigational group during the study, three of which were attributed to sudden infant death syndrome. These deaths occurred in a time frame beyond any practical association with the vaccine, he said. There was one case of SIDS reported in the control group.

“Instead of lots of sticks in backs, bladders, veins and quadriceps, you are going to do fewer sticks,” Block said. “Hexavalent vaccine is your vaccine of the future.” – by David Costill

Reference:

Block SL, et al. Abstract 31830. Presented at: AAP National Conference and Exhibition; Oct. 24-27, 2015; Washington, D.C.

Disclosure: Block reports financial ties with Merck and Sanofi Pasteur, who funded the study, and GlaxoSmithKline.