PMID- 26308112
OWN - NLM
STAT- MEDLINE
DCOM- 20161213
LR  - 20181113
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 12
IP  - 2
DP  - 2016
TI  - Concomitant use of VAQTA with PedvaxHIB and Infanrix in 12 to 17 month old 
      children.
PG  - 503-11
LID - 10.1080/21645515.2015.1080395 [doi]
AB  - Open-label, multicenter, randomized study (NCT00289913) evaluated immunogenicity, 
      safety, and tolerability of Vaqta (hepatitis A vaccine) administered with 
      PedvaxHIB (Haemophilus b conjugate vaccine [Meningococcal protein conjugate]) & 
      Infanrix (diphtheria/tetanus/acellular pertussis vaccine) in healthy, 
      15-month-old children. Five groups were evaluated: Group 1 received 
      Vaqta/Infanrix PedvaxHIB on Day-1 and Vaqta at Week-24; Group 2 received Infanrix 
      PedvaxHIB on Day-1, Vaqta at Week-4, and Vaqta at Week-28; Group 3 received 
      Vaqta/PedvaxHIB on Day-1 and Vaqta Week-24; Group 4 received PedvaxHIB on Day-1, 
      Vaqta at Week-4, and Vaqta at Week-28; and Group 5 (safety only) received Vaqta 
      on Day-1 and Vaqta at Week-24. Hepatitis A seropositivity rate (SPR: >/=10 mIU/mL), 
      Hib capsular polyribosylribitol phosphate (PRP) antibody response (>1.0 mug/mL), 
      and geometric mean titers (GMT) to pertussis toxin (PT), pertussis filamentous 
      hemagglutinin antibody (FHA), and pertactin were examined. Non-inferiority 
      statistical criteria required a difference >10% in Hepatitis A SPR, PRP >1.0 
      mug/mL, and a GMT ratio of >0.67 for pertussis antigens. Injection-site and 
      systemic adverse events (AEs) and daily temperatures were collected. Hepatitis A 
      SPRs were 100% for Groups 1-4, regardless of initial serostatus. Anti-PRP titers 
      were comparable (98.1% - 97.0%) for Groups 1-4. GMT and mean fold-rise were 
      comparable for all 3 pertussis antigen components between concomitant and 
      nonconcomitant groups. Criteria for non-inferiority of immune responses for 
      concomitant vs nonconcomitant administration were met for Hepatitis A, Hib, and 
      pertussis antigens. No statistically significant incidence differences of 
      individual AEs were found between concomitant and nonconcomitant groups. No 
      serious vaccine-related AEs or deaths were reported; no subject discontinued due 
      to an AE. Immune responses to Vaqta, PedvaxHIB, and Infanrix given concomitantly 
      were non-inferior to nonconcomitant responses. Vaqta administered with PedvaxHIB 
      & Infanrix had an acceptable safety profile in 15-month-old children.
FAU - Petrecz, Maria
AU  - Petrecz M
AD  - a Merck & Co., Inc. ; Kenilworth , NJ USA.
FAU - Ramsey, Keith P
AU  - Ramsey KP
AD  - b Jordan Ridge Kids & Teens ; West Jordan , UT USA.
FAU - Stek, Jon E
AU  - Stek JE
AD  - a Merck & Co., Inc. ; Kenilworth , NJ USA.
FAU - Martin, Jason C
AU  - Martin JC
AD  - a Merck & Co., Inc. ; Kenilworth , NJ USA.
FAU - Klopfer, Stephanie O
AU  - Klopfer SO
AD  - a Merck & Co., Inc. ; Kenilworth , NJ USA.
FAU - Kuter, Barbara
AU  - Kuter B
AD  - a Merck & Co., Inc. ; Kenilworth , NJ USA.
FAU - Schodel, Florian P
AU  - Schodel FP
AD  - a Merck & Co., Inc. ; Kenilworth , NJ USA.
FAU - Lee, Andrew W
AU  - Lee AW
AD  - a Merck & Co., Inc. ; Kenilworth , NJ USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT00289913
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Antibodies, Bacterial)
RN  - 0 (Bacterial Outer Membrane Proteins)
RN  - 0 (Diphtheria-Tetanus-acellular Pertussis Vaccines)
RN  - 0 (Haemophilus Vaccines)
RN  - 0 (Haemophilus influenzae-type b polysaccharide-Neisseria meningitidis outer 
      membrane protein conjugate vaccine)
RN  - 0 (Hepatitis A Vaccines)
RN  - 0 (Polysaccharides, Bacterial)
RN  - 0 (Vaccines, Combined)
RN  - 0 (Vaccines, Conjugate)
RN  - 0 (Virulence Factors, Bordetella)
RN  - 63GD90PP8X (pertactin)
SB  - IM
MH  - Antibodies, Bacterial/blood
MH  - Bacterial Outer Membrane Proteins/adverse effects/*immunology
MH  - Diphtheria/immunology/prevention & control
MH  - Diphtheria-Tetanus-acellular Pertussis Vaccines/adverse effects/*immunology
MH  - Haemophilus Infections/immunology/prevention & control
MH  - Haemophilus Vaccines/adverse effects/*immunology
MH  - Hepatitis A/immunology/prevention & control
MH  - Hepatitis A Vaccines/adverse effects/*immunology
MH  - Humans
MH  - Immunogenicity, Vaccine/*immunology
MH  - Infant
MH  - Polysaccharides, Bacterial/adverse effects/*immunology
MH  - Tetanus/immunology/prevention & control
MH  - Vaccines, Combined/*adverse effects/*immunology
MH  - Vaccines, Conjugate/adverse effects/immunology
MH  - Virulence Factors, Bordetella/immunology
MH  - Whooping Cough/immunology/prevention & control
PMC - PMC5049725
OTO - NOTNLM
OT  - H. influenzae type b
OT  - concomitant use
OT  - diphtheria
OT  - hepatitis A
OT  - immunogenicity
OT  - pertussis
OT  - safety
OT  - tetanus
OT  - vaccine
EDAT- 2015/08/27 06:00
MHDA- 2016/12/15 06:00
PMCR- 2016/08/26
CRDT- 2015/08/27 06:00
PHST- 2015/08/27 06:00 [entrez]
PHST- 2015/08/27 06:00 [pubmed]
PHST- 2016/12/15 06:00 [medline]
PHST- 2016/08/26 00:00 [pmc-release]
AID - 1080395 [pii]
AID - 10.1080/21645515.2015.1080395 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2016;12(2):503-11. doi: 10.1080/21645515.2015.1080395.