title: Lot-to-lot consistency study of the fully liquid pentavalent DTwP-HepB-Hib vaccine Quinvaxem (®)  demonstrating clinical equivalence, suitability of the vaccine as a booster and concomitant administration with measles vaccine.
abstract: This double-blind, randomized study evaluated the immunogenicity and safety of three production lots of the fully liquid combination DTwP-Hep-Hib vaccine, Quinvaxem (®)  (Crucell, The Netherlands) in 360 healthy infants aged 42-64 d old given at 6, 10 and 14 weeks of age (Core Study). The Core Study was followed by an open-label Booster Phase evaluating immunogenicity and safety of a booster dose of Quinvaxem (®)  given with either concomitant or deferred measles vaccine in 227 infants who completed the Core Study. One month after the third dose of Quinvaxem (®)  immune responses reflecting seroprotection or seroconversion were observed in more than 90% of infants for all three vaccine lots. Quinvaxem (®)  elicited a strong booster response as demonstrated by a large increase in antibodies against all antigens, which appeared to be unaffected by concomitant administration of the measles vaccine. Safety results were in line with previous reports for Quinvaxem (®)  with no unexpected adverse events (AEs) being reported. In the Core Study and Booster Phase, Quinvaxem (®)  was well tolerated. No study vaccine-related serious AEs were reported. Thus, Quinvaxem (®)  was immunogenic and well-tolerated when administered to infants according to a 6-10-14 week vaccination schedule. The three production lots had consistent reactogenicity and immunogenicity profiles. The booster dose of Quinvaxem (®)  was also immunogenic and safe, regardless of whether a monovalent measles vaccine was administered concomitantly or one month later.
authors.affiliation: Synexus Clinical Research SA (Pty) Ltd, Pretoria, South Africa.
authors.forename: Sanet
authors.initials: S
authors.lastname: Aspinall
authors.forename: Deirdre
authors.initials: D
authors.lastname: Traynor
authors.forename: Philip
authors.initials: P
authors.lastname: Bedford
authors.forename: Katharina
authors.initials: K
authors.lastname: Hartmann
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005260:Female; D018073:Haemophilus Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D017325:Hepatitis B Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D006801:Humans; D007114:Immunization / Q000009:adverse effects* / Q000379:methods*; D007223:Infant; D008297:Male; D008458:Measles Vaccine / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D013678:Technology, Pharmaceutical / Q000592:standards*
chemical_list: D000907:Antibodies, Bacterial; D000914:Antibodies, Viral; D015721:Diphtheria-Tetanus-Pertussis Vaccine; C524361:DtwP-HepB-Hib vaccine; D018073:Haemophilus Vaccines; D017325:Hepatitis B Vaccines; D008458:Measles Vaccine