NDLI: Concomitant administration of hepatitis A vaccine with measles/mumps/rubella/varicella and pneumococcal vaccines in healthy 12- to 23-month-old children.

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Concomitant administration of hepatitis A vaccine with measles/mumps/rubella/varicella and pneumococcal vaccines in healthy 12- to 23-month-old children.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Yetman, Robert J. Shepard, Julie S. Duke, Anton Stek, Jon E. Petrecz, Maria Klopfer, Stephanie O. Kuter, Barbara J. Schödel, Florian P. Lee, Andrew W.
Description	Author Affiliation: Yetman RJ ( University of Texas, Houston)
Abstract	This open-label, multicenter, randomized, comparative study evaluated immunogenicity, safety and tolerability of concomitant (Group 1; n=330) vs. non-concomitant (Group 2; n=323) VAQTA™ (25U/0.5 mL) (hepatitis A vaccine; HAV) with ProQuad™ (measles/mumps/rubella/varicella; MMRV) and Prevnar™ (7-valent pneumococcal; PCV-7) in healthy, 12-23 mo old children. Group 1 received HAV/MMRV/PCV-7 concomitantly on Day 1 and second doses of HAV/MMRV at Week 24. Group 2 received MMRV/PCV-7 on Day 1, HAV at Weeks 6 and 30 and MMRV at Week 34. Hepatitis A seropositivity rate (SPR: ≥10 mIU/mL; 4 weeks postdose 2), varicella zoster-virus (VZV) SPR (≥5 gpELISA units/mL) and geometric mean titers (GMT) to S. pneumoniae were examined. Injection-site and systemic adverse experiences (AEs) and daily temperatures were collected. Hepatitis A SPR were 100% for Group 1 and 99.4% for Group 2 after two HAV doses; risk difference=0.7 (95%CI: -1.4,3.8, non-inferior) regardless of initial serostatus. VZV SPR was 93.3% for Group 1 and 98.3% for Group 2; risk difference=-5.1 (95%CI: -9.3, -1.4; non-inferior). S. pneumoniae GMT fold-difference (7 serotypes) ranged from 0.9 to 1.1; non-inferior. No statistically significant differences in the incidence of individual AEs were seen when HAV was administered concomitantly vs. non-concomitantly. Three (all Group 2 post-administration of MMRV/PCV-7) of 11 serious AEs were considered possibly vaccine-related: dehydration and gastroenteritis (same subject) on Day 52; febrile seizure on Day 9. No deaths were reported. Antibody responses to each vaccine given concomitantly were non-inferior to HAV given non-concomitantly with MMRV and PCV-7. Administration of HAV with PCV-7 and MMRV had an acceptable safety profile in 12- to 23-mo-old children.
File Format	HTM / HTML
ISSN	21645515
e-ISSN	2164554X
DOI	10.4161/hv.24873
Journal	Human Vaccines & Immunotherapeutics
Issue Number	8
Volume Number	9
Language	English
Publisher	Taylor & Francis
Publisher Date	2013-08-01
Publisher Place	United States
Access Restriction	Open
Subject Keyword	Discipline Immunology Discipline Therapeutics Chickenpox Vaccine Immunology Hepatitis A Vaccines Immunization Schedule Measles-mumps-rubella Vaccine Pneumococcal Vaccines Vaccination Antibodies, Bacterial Blood Antibodies, Viral Administration & Dosage Adverse Effects Drug-related Side Effects And Adverse Reactions Epidemiology Pathology Enzyme-linked Immunosorbent Assay Heptavalent Pneumococcal Conjugate Vaccine Infant Vaccines, Combined Multicenter Study Randomized Controlled Trial Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Immunology and Allergy Immunology Pharmacology

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