1112A Phase III Study of the Safety, Tolerability and Immunogenicity of an Investigational Combination Vaccine against Diphtheria, Tetanus, Pertussis (DTaP5), Polio (IPV), Haemophilus influenzae type b (Hib; PRP-OMPC), and Hepatitis B (HepB) in US Infants
نویسندگان
چکیده
an Investigational Combination Vaccine against Diphtheria, Tetanus, Pertussis (DTaP5), Polio (IPV), Haemophilus influenzae type b (Hib; PRPOMPC), and Hepatitis B (HepB) in US Infants Gary S. Marshall, MD; Gregory Adams, MD; Michael Leonardi, MD; Maria Petrecz, BSBA, MLT(ASCP); Sheryl Flores; Angela Ngai, BS, MT(ASCP); Jin Xu, PhD; Ginamarie Foglia, DO, MPH; Andrew Wen-Tseng Lee, MD; Study Team (NCT01337167); Pediatrics, University of Louisville School of Medicine, Louisville, KY; Blue Ridge Pediatric and Adolescent Medicine, Boone, NC; Palmetto Pediatrics PA, Charleston, SC; Merck and Co., Inc., Whitehouse Station, NJ; Clinical Development, Sanofi Pasteur, Swiftwater, PA
منابع مشابه
Randomized, controlled, multicenter study of the immunogenicity and safety of a fully liquid combination diphtheria-tetanus toxoid-five-component acellular pertussis (DTaP5), inactivated poliovirus (IPV), and haemophilus influenzae type b (Hib) vaccine compared with a DTaP3-IPV/Hib vaccine administered at 3, 5, and 12 months of age.
This study compared the levels of immunogenicity and safety of diphtheria-tetanus toxoid-five-component acellular pertussis (DTaP(5)), inactivated poliovirus (IPV), and Haemophilus influenzae type b (Hib) (DTaP(5)-IPV-Hib) and DTaP(3)-IPV/Hib vaccines for study participants 3, 5, and 12 months of age. Post-dose 3 noninferiority criteria comparing DTaP(5)-IPV-Hib to DTaP(3)-IPV/Hib using rates o...
متن کاملImmunogenicity and Safety of Quinvaxem® (diphtheria, Tetanus, Whole-cell Pertussis, Hepatitis B and Haemophilus Influenzae Type B Vaccine) given to Vietnamese Infants at 2 to 4 Months of Age.
Vietnam plans to replace the routine childhood diphtheria, pertussis and tetanus combination (DPT) vaccine with a pentavalent vaccine. The present study was performed to assess the immunogenicity and safety of the combined diphtheria, tetanus, whole-cell pertussis, hepatitis B (HepB), and Haemophilus influenzae type b (Hib) (DTwP-HepB-Hib) Quinvaxem® vaccine in children. A total of 131 infants ...
متن کاملImmunogenicity and safety of primary and booster vaccination with 2 investigational formulations of diphtheria, tetanus and Haemophilus influenzae type b antigens in a hexavalent DTPa-HBV-IPV/Hib combination vaccine in comparison with the licensed Infanrix hexa
Safety and immunogenicity of 2 investigational formulations of diphtheria, tetanus and Haemophilus influenzae type b antigens of the combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliomyelitis-Hib vaccine (DTPa-HBV-IPV/Hib) were evaluated in a Primary (NCT01248884) and a Booster vaccination (NCT01453998) study. In the Primary study, 721 healthy infants (randomized 1:1:...
متن کاملImmunogenicity and safety of a combination diphtheria, tetanus toxoid, acellular pertussis, hepatitis B, and inactivated poliovirus vaccine coadministered with a 7-valent pneumococcal conjugate vaccine and a Haemophilus influenzae type b conjugate vaccine.
OBJECTIVE To evaluate the immunogenicity and safety of a diphtheria and tetanus toxoids, acellular pertussis, hepatitis B, and inactivated poliovirus-containing vaccine (DTaP-HepB-IPV) coadministered with pneumococcal 7-valent conjugate vaccine (PCV-7) and Haemophilus influenzae type b vaccine (Hib), with separate vaccines concurrently, or staggered (delayed) administration of PCV-7. STUDY DE...
متن کاملImmunogenicity, Safety, and Tolerability of a Hexavalent Vaccine in Infants.
BACKGROUND DTaP5-IPV-Hib-HepB is a fully liquid investigational hexavalent vaccine directed against 6 diseases. METHODS This multicenter, open-label, comparator-controlled, phase III study randomly assigned healthy infants 2-to-1 as follows: group 1 received DTaP5-IPV-Hib-HepB, PCV13, and RV5 at 2, 4, and 6 months of age followed by DTaP5, Hib-OMP, and PCV13 at 15 months of age; group 2 recei...
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