PMID- 22854660
OWN - NLM
STAT- MEDLINE
DCOM- 20130515
LR  - 20211021
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 8
IP  - 8
DP  - 2012 Aug
TI  - Lot-to-lot consistency study of the fully liquid pentavalent DTwP-HepB-Hib 
      vaccine Quinvaxem ((R)) demonstrating clinical equivalence, suitability of the 
      vaccine as a booster and concomitant administration with measles vaccine.
PG  - 1109-18
LID - 10.4161/hv.21095 [doi]
AB  - This double-blind, randomized study evaluated the immunogenicity and safety of 
      three production lots of the fully liquid combination DTwP-Hep-Hib vaccine, 
      Quinvaxem ((R)) (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 ((R)) given with either concomitant or deferred measles vaccine 
      in 227 infants who completed the Core Study. One month after the third dose of 
      Quinvaxem ((R)) immune responses reflecting seroprotection or seroconversion were 
      observed in more than 90% of infants for all three vaccine lots. Quinvaxem ((R)) 
      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 ((R)) with no unexpected adverse events (AEs) being reported. 
      In the Core Study and Booster Phase, Quinvaxem ((R)) was well tolerated. No study 
      vaccine-related serious AEs were reported. Thus, Quinvaxem ((R)) 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 ((R)) was also immunogenic 
      and safe, regardless of whether a monovalent measles vaccine was administered 
      concomitantly or one month later.
FAU - Aspinall, Sanet
AU  - Aspinall S
AD  - Synexus Clinical Research SA (Pty) Ltd, Pretoria, South Africa.
FAU - Traynor, Deirdre
AU  - Traynor D
FAU - Bedford, Philip
AU  - Bedford P
FAU - Hartmann, Katharina
AU  - Hartmann K
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20120801
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Antibodies, Bacterial)
RN  - 0 (Antibodies, Viral)
RN  - 0 (Diphtheria-Tetanus-Pertussis Vaccine)
RN  - 0 (DtwP-HepB-Hib vaccine)
RN  - 0 (Haemophilus Vaccines)
RN  - 0 (Hepatitis B Vaccines)
RN  - 0 (Measles Vaccine)
SB  - IM
EIN - Hum Vaccin Immunother. 2013 Apr;9(4):937
MH  - Antibodies, Bacterial/blood
MH  - Antibodies, Viral/blood
MH  - Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage/*adverse 
      effects/*immunology
MH  - Double-Blind Method
MH  - Drug-Related Side Effects and Adverse Reactions/epidemiology
MH  - Female
MH  - Haemophilus Vaccines/administration & dosage/*adverse effects/*immunology
MH  - Hepatitis B Vaccines/administration & dosage/*adverse effects/*immunology
MH  - Humans
MH  - Immunization/*adverse effects/*methods
MH  - Infant
MH  - Male
MH  - Measles Vaccine/administration & dosage/*adverse effects/*immunology
MH  - Technology, Pharmaceutical/*standards
PMC - PMC3551883
EDAT- 2012/08/03 06:00
MHDA- 2013/05/17 06:00
PMCR- 2013/08/01
CRDT- 2012/08/03 06:00
PHST- 2012/08/03 06:00 [entrez]
PHST- 2012/08/03 06:00 [pubmed]
PHST- 2013/05/17 06:00 [medline]
PHST- 2013/08/01 00:00 [pmc-release]
AID - 21095 [pii]
AID - 2012HV0114R [pii]
AID - 10.4161/hv.21095 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2012 Aug;8(8):1109-18. doi: 10.4161/hv.21095. Epub 2012 
      Aug 1.