Abstract
To assess the safety, tolerability and immunogenicity of COMVAX, a liquid, bivalent Haemophilus influenzae type b-hepatitis B vaccine, containing the polyribosylribitol phosphate (PRP)-Neisseria meningitidis outer membrane protein complex conjugate used in the Hib vaccine, PedvaxHIB, and the yeast-derived hepatitis B surface antigen (HBsAg) used in the HB vaccine, RECOMBIVAX HB. Eight hundred eighty-two healthy infants, approximately 2 months of age, were enrolled in an open, multicenter (n = 11) clinical trial and randomized to receive either COMVAX (7.5 micrograms of PRP/5 micrograms of HBsAg in 0.5 ml) or concurrent injections of the liquid formulation of PedvaxHIB (P) (7.5 micrograms of PRP in 0.5 ml) and RECOMBIVAX HB (R) (5 micrograms of HBsAg in 0.5 ml) at 2, 4 and 12 or 15 months of age. Safety and tolerability were monitored after each injection. The serum concentrations of anti-PRP and anti-HBs were determined at the time of each vaccination, 2 months after the second vaccination and 1 month after the third vaccination. COMVAX was well-tolerated and proved to be immunologically comparable with a series of concomitant P+R injections. There were no serious adverse experiences attributable to the study vaccines. The most...Continue Reading
References
Oct 1, 1992·The Pediatric Infectious Disease Journal·D J West, H S Margolis
Jun 20, 1991·The New England Journal of Medicine·M SantoshamW Newcomer
Jun 1, 1990·Pediatric Clinics of North America·D J WestR W Ellis
Mar 1, 1973·Pediatric Research·J B RobbinsJ K Whisnant
Apr 23, 1983·British Medical Journal·R A CoutinhoH W Reesink
Jun 1, 1983·The Journal of Infectious Diseases·H KäyhtyP H Mäkelä
Jun 1, 1984·The Journal of Infectious Diseases·P Anderson
Sep 1, 1982·Annals of Internal Medicine·D P FrancisA G Redeker
Sep 1, 1981·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·W SzmunessA Kellner
Jul 1, 1994·The Journal of Pediatrics·H L KeyserlingG B Calandra
Sep 1, 1993·The Journal of Infectious Diseases·D M GranoffT V Murphy
Jan 13, 1993·JAMA : the Journal of the American Medical Association·W G AdamsJ D Wenger
Jan 1, 1993·Vaccine·D J WestW J Miller
Aug 1, 1996·Vaccine·D J West, G B Calandra
Citations
Apr 6, 2004·Vaccine·Eric MalletUNKNOWN Hexavalent Vaccine Trial Study Group
Dec 12, 2001·Primary Care·M D Decker
Nov 27, 2002·Vaccine·Karen M KaplanJohn W Boslego
Jan 23, 1999·Vaccine·M A Kane
Apr 9, 1999·Vaccine·A W SturgessJ P Hennessy
Apr 9, 1999·Vaccine·R W Ellis
Dec 26, 2001·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·C T Le
Mar 12, 2004·The Pediatric Infectious Disease Journal·Teresa M HesleyUNKNOWN HIB-HB VACCINE STUDY GROUP
Jul 29, 2009·The Pediatric Infectious Disease Journal·Richard DohertyWalter Straus
Aug 10, 2001·Australian and New Zealand Journal of Public Health·A HarrisM Kermode
Aug 25, 2001·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·D J WestT M Hesley
Apr 14, 2006·Expert Opinion on Drug Safety·Naor Bar-Zeev, Jim P Buttery
Sep 10, 2004·Pediatric Annals·Gary S Marshall
Apr 13, 2000·Pediatric Clinics of North America·M E Pichichero
Mar 10, 2001·Biologicals : Journal of the International Association of Biological Standardization·L A SwartzJ C May
Apr 26, 2000·Canadian Journal of Microbiology·S MiyazakiK Yamaguchi
Sep 3, 1999·Journal of Biopharmaceutical Statistics·B L Wiens, B Iglewicz