Jon E. Stek
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View article: A phase 3 randomized, open-label study evaluating the immunogenicity and safety of concomitant and staggered administration of a live, pentavalent rotavirus vaccine and an inactivated poliomyelitis vaccine in healthy infants in China
A phase 3 randomized, open-label study evaluating the immunogenicity and safety of concomitant and staggered administration of a live, pentavalent rotavirus vaccine and an inactivated poliomyelitis vaccine in healthy infants in China Open
This open-label, randomized, phase 3 study in China (V260-074; NCT04481191) evaluated the immunogenicity and safety of concomitant and staggered administration of three doses of an oral, live, pentavalent rotavirus vaccine (RV5) and three …
View article: A phase 3, multicenter, randomized, double-blind, active-comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of a 4-dose regimen of V114, a 15-valent pneumococcal conjugate vaccine, in healthy infants (PNEU-PED)
A phase 3, multicenter, randomized, double-blind, active-comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of a 4-dose regimen of V114, a 15-valent pneumococcal conjugate vaccine, in healthy infants (PNEU-PED) Open
ClinicalTrials.gov: NCT03893448; EudraCT: 2018-004109-21.
View article: 336 A phase 3, multicenter, randomised, double-blind, active-comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of a 4-dose regimen of v114 in healthy infants (PNEU-PED)
336 A phase 3, multicenter, randomised, double-blind, active-comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of a 4-dose regimen of v114 in healthy infants (PNEU-PED) Open
Aims Pneumococcal disease (PD) remains a major health concern globally. Pneumococcal conjugate vaccines (PCVs) confer protection against PD caused by most vaccine serotypes, but residual disease remains partly due to non-vaccine serotypes.…
View article: Sequential administration of Prevnar 13™ and PNEUMOVAX™ 23 in healthy participants 50 years of age and older
Sequential administration of Prevnar 13™ and PNEUMOVAX™ 23 in healthy participants 50 years of age and older Open
In most countries worldwide, pneumococcal conjugate vaccines have been included in the infant immunization program, resulting in a significant reduction in the burden of pneumococcal disease in children and adults. Shifting serotype distri…
View article: Using the power law model to predict the long-term persistence and duration of detectable hepatitis A antibody after receipt of hepatitis A vaccine (VAQTA™)
Using the power law model to predict the long-term persistence and duration of detectable hepatitis A antibody after receipt of hepatitis A vaccine (VAQTA™) Open
VAQTA™ (Hepatitis A Vaccine, inactivated [HAVi]; Merck & Co., Inc., Kenilworth, NJ, USA) is currently licensed for prevention of disease caused by hepatitis A virus in persons ≥12 months of age. This report summarizes statistical models de…
View article: Safety and immunogenicity of a fully-liquid DTaP-IPV-Hib-HepB vaccine (Vaxelis™) in premature infants
Safety and immunogenicity of a fully-liquid DTaP-IPV-Hib-HepB vaccine (Vaxelis™) in premature infants Open
Background: Immune immaturity may put premature infants at increased risk for infections. DTaP-IPV-Hib-HepB vaccine (Vaxelis™), a hexavalent vaccine studied in >6,800 children, has acceptable safety and immunogenicity profiles generally si…
View article: 2702. Infants Vaccinated with a Fully-Liquid DTaP-IPV-Hib-HepB Vaccine Are Protected During the High-Risk Period for Haemophilus Influenzae Type B Disease
2702. Infants Vaccinated with a Fully-Liquid DTaP-IPV-Hib-HepB Vaccine Are Protected During the High-Risk Period for Haemophilus Influenzae Type B Disease Open
Background DTaP-IPV-Hib-HepB is a fully-liquid, combination vaccine (Vaxelis™) approved for vaccination in infants and toddlers against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b (Hib). Saf…
View article: Safety and immunogenicity of VAQTA® in children 12-to-23 months of age with and without administration of other US pediatric vaccines
Safety and immunogenicity of VAQTA® in children 12-to-23 months of age with and without administration of other US pediatric vaccines Open
Safety and immunogenicity data from 5 clinical trials conducted in the US in children 12-to-23 months old where HAVi was administered alone or concomitantly with other pediatric vaccines (M-M-R®II, Varivax®, TRIPEDIA®, Prevnar®, ProQuad®, …
View article: 1972. Safety and Immunogenicity of 15-Valent Pneumococcal Conjugate Vaccine (PCV-15) Compared with PCV-13 in Healthy Older Adults Previously Vaccinated With 23-Valent Pneumococcal Polysaccharide Vaccine (PPV23)
1972. Safety and Immunogenicity of 15-Valent Pneumococcal Conjugate Vaccine (PCV-15) Compared with PCV-13 in Healthy Older Adults Previously Vaccinated With 23-Valent Pneumococcal Polysaccharide Vaccine (PPV23) Open
BACKGROUND: Safety and immunogenicity of a new formulation of PCV-15 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19F, 19A, 22F*, 23F, 33F*) was evaluated in adults ≥65 years of age previously vaccinated with PPV23. METHODS: Study subjects who re…
View article: Immunogenicity and safety of zoster vaccine live administered with quadrivalent influenza virus vaccine
Immunogenicity and safety of zoster vaccine live administered with quadrivalent influenza virus vaccine Open
The concomitant administration of ZV and IIV4 to adults≥50years of age induced VZV-specific and influenza-specific antibody responses that were comparable to those following administration of either vaccine alone, and was generally well to…
View article: Safety and Immunogenicity of Inactivated Varicella-Zoster Virus Vaccine in Adults With Autoimmune Disease: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Safety and Immunogenicity of Inactivated Varicella-Zoster Virus Vaccine in Adults With Autoimmune Disease: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Clinical Trial Open
NCT01527383.
View article: A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Clinical Trial to Study the Safety, Tolerability, Efficacy, and Immunogenicity of Inactivated Vzv Vaccine (ZVIN) in Recipients of Autologous Hematopoietic Cell Transplants (Auto-Hcts)
A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Clinical Trial to Study the Safety, Tolerability, Efficacy, and Immunogenicity of Inactivated Vzv Vaccine (ZVIN) in Recipients of Autologous Hematopoietic Cell Transplants (Auto-Hcts) Open
Background: Recipients of auto-HCT have an increased risk of Herpes Zoster (HZ) infection and its complications, including postherpetic neuralgia (PHN), secondary bacterial infection, disseminated Varicella Zoster Virus (VZV) infection, ho…
View article: Concomitant administration of diphtheria, tetanus, acellular pertussis and inactivated poliovirus vaccine derived from Sabin strains (DTaP-sIPV) with pentavalent rotavirus vaccine in Japanese infants
Concomitant administration of diphtheria, tetanus, acellular pertussis and inactivated poliovirus vaccine derived from Sabin strains (DTaP-sIPV) with pentavalent rotavirus vaccine in Japanese infants Open
Rotavirus is the leading cause of severe acute gastroenteritis in infants and young children. Most children are infected with rotavirus, and the health and economic burdens of rotavirus gastroenteritis on healthcare systems and families ar…
View article: Safety and immunogenicity of a single dose 23-valent pneumococcal polysaccharide vaccine in Russian subjects
Safety and immunogenicity of a single dose 23-valent pneumococcal polysaccharide vaccine in Russian subjects Open
PPV23 is generally safe, well tolerated, and highly immunogenic when given as a single dose to Russian individuals 50 y of age and older, as well as Russian individuals 2 to 49 y of age who are at high risk for PD.
View article: A double blind, randomized, active controlled study to assess the safety, tolerability and immunogenicity of measles, mumps rubella, and varicella vaccine (MMRV) manufactured using an alternative process
A double blind, randomized, active controlled study to assess the safety, tolerability and immunogenicity of measles, mumps rubella, and varicella vaccine (MMRV) manufactured using an alternative process Open
Vaccination against measles, mumps, rubella, and varicella is recommended for all children in the US. Limitations manufacturing Oka/Merck strain varicella-zoster virus have hampered the availability of the combination vaccine (MMRV) agains…
View article: Vaccination of adults with 23-valent pneumococcal polysaccharide vaccine induces robust antibody responses against pneumococcal serotypes associated with serious clinical outcomes
Vaccination of adults with 23-valent pneumococcal polysaccharide vaccine induces robust antibody responses against pneumococcal serotypes associated with serious clinical outcomes Open
PNEUMOVAX™ 23, a 23-valent polysaccharide pneumococcal vaccine (PPV23), covers 65% to 91% of the isolates recovered from adult cases of invasive pneumococcal disease. Several studies have demonstrated that pneumococcal serotypes 31, 11A, 3…
View article: Concomitant use of VAQTA® with PedvaxHIB® and Infanrix® in 12 to 17 month old children
Concomitant use of VAQTA® with PedvaxHIB® and Infanrix® in 12 to 17 month old children Open
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]) & Inf…