WHITEHOUSE STATION, N.J. & LYON, France—A new Phase IIIclinical program was recently launched by Merck (known outside the UnitedStates and Canada as MSD) and Sanofi Pastuer, sanofi-aventis Group's vaccinesdivision, for evaluating the safety and immunogenicity of an investigationalpediatric hexavalent combination vaccine. The vaccine, known as V419 in Merck'spipeline chart and DTP-HepB-Polio-Hib Pediatric hexavalent vaccine on the pipelinecharts of sanofi-aventis and Sanofi Pasteur, is being developed as part of apartnership between Merck and Sanofi Pasteur to develop pediatric combinationvaccines. It is designed to aid in the protection against six diseases,including tetanus, whooping cough (Bordetella pertussis), diphtheria, polio(poliovirus types 1, 2 and 3), hepatitis B and invasive disease caused byHaemophilus influenzae type b.
The Phase III program started after results from a Phase IIbclinical trial that demonstrated the safety and immunogenicity of thecombination vaccine in 459 children.
"Based on the results of Phase II trials, we are pleased tomove this investigational hexavalent combination vaccine to a late-stageclinical program," says Michel DeWilde, Ph.D., senior vice president ofResearch and Development at Sanofi Pasteur. "We partnered with Merck to draw onthe companies'
combined leadership, experience and expertise in thedevelopment, manufacturing and marketing of pediatric combination vaccines."
The investigational vaccine combines select components:DTaP5-IPV-Hib- HepB; Diphtheria and Tetanus Toxoids and Acellular PertussisAdsorbed, Inactivated Poliovirus, Haemophilus b Conjugate (Meningococcal OuterMembrane Protein Complex) and Hepatitis B (Recombinant) Vaccine.
"The need to consolidate vaccinations for infants willbecome increasingly important as the number of diseases that vaccines helpprevent continues to increase," says Tony Ford-Hutchinson, Ph.D., senior vicepresident of Vaccines Research at Merck.
In the U.S., the American Academy of Pediatrics (AAP), theAmerican Academy of Family Physicians (AAFP) and the Advisory Committee onImmunization Practices (ACIP) recommend combination vaccines over individualones, given the potential that combination vaccines represent for improvedcoverage.
"Combination vaccines simplify the childhood immunizationschedule and may improve coverage, on time vaccination and reduce the number ofinjections for children," says Gary S. Marshall, M.D., professor of pediatricsat the University of Louisville School of Medicine.
Ford-Hutchinson agrees, noting that "the development of ahexavalent combination vaccine is complex."
"The ability to share expertise and capabilities with ourpartner Sanofi Pasteur is fundamental in reaching our shared goal of developingnew combination vaccines that may improve vaccination rates of children," saysFord-Hutchinson.
The Phase III clinical trial will begin in the U.S. as arandomized, open-label, active-comparator controlled clinical trial, and willconsist of approximately 1,440 infants at multiple centers. Primary studyobjectives include assessing the combination vaccine's safety andimmunogenicity when administered at 2, 4 and 6 months of age concomitantly withPrevnar 13TM Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197Protein) and ROTATEQ (Rotavirus Vaccine, Live, Oral, Pentavalent). The clinicalprogram is slated to begin in Europe this year as well.