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View article: Pivotal Phase 3 Randomized Clinical Trial of the Safety, Tolerability, and Immunogenicity of 20-Valent Pneumococcal Conjugate Vaccine in Adults Aged ≥18 Years
Pivotal Phase 3 Randomized Clinical Trial of the Safety, Tolerability, and Immunogenicity of 20-Valent Pneumococcal Conjugate Vaccine in Adults Aged ≥18 Years Open
Background Pneumococcal conjugate vaccines (PCVs) have significantly reduced pneumococcal disease, but disease from non-PCV serotypes remains. The safety, tolerability, and immunogenicity of a 20-valent PCV (PCV20) were evaluated. Methods …
View article: A randomized phase 1/2 study of the safety and immunogenicity of a multivalent pneumococcal conjugate vaccine in healthy adults 50 through 85 years of age
A randomized phase 1/2 study of the safety and immunogenicity of a multivalent pneumococcal conjugate vaccine in healthy adults 50 through 85 years of age Open
Pneumococcal disease can be serious and debilitating in older adults. Pneumococcal conjugate vaccines (PCVs), such as the 13-valent PCV (PCV13), reduce pneumococcal disease rates caused by vaccine serotypes. Development of PCVs offering ad…
View article: The adjuvanted recombinant zoster vaccine co-administered with a tetanus, diphtheria and pertussis vaccine in adults aged ≥50 years: A randomized trial
The adjuvanted recombinant zoster vaccine co-administered with a tetanus, diphtheria and pertussis vaccine in adults aged ≥50 years: A randomized trial Open
Co-administration of RZV and Tdap did not interfere with the humoral immune response to RZV or 4 of the 5 Tdap antigens. No safety concerns were identified.
View article: Medical conditions at enrollment do not impact efficacy and safety of the adjuvanted recombinant zoster vaccine: a pooled post-hoc analysis of two parallel randomized trials
Medical conditions at enrollment do not impact efficacy and safety of the adjuvanted recombinant zoster vaccine: a pooled post-hoc analysis of two parallel randomized trials Open
In two pivotal efficacy studies (ZOE-50; ZOE-70), the adjuvanted recombinant zoster vaccine (RZV) demonstrated >90% efficacy against herpes zoster (HZ).Adults aged ≥50 or ≥70 years (ZOE-50 [NCT01165177]; ZOE-70 [NCT01165229]) were randomiz…
View article: Safety profile of the adjuvanted recombinant zoster vaccine: Pooled analysis of two large randomised phase 3 trials
Safety profile of the adjuvanted recombinant zoster vaccine: Pooled analysis of two large randomised phase 3 trials Open
View article: Corrigendum to ‘Immunogenicity and safety of the adjuvanted recombinant zoster vaccine co-administered with the 23-valent pneumococcal polysaccharide vaccine in adults ≥50 years of age: A randomized trial’ [Vaccine 36 (2018) 4278–4286]
Corrigendum to ‘Immunogenicity and safety of the adjuvanted recombinant zoster vaccine co-administered with the 23-valent pneumococcal polysaccharide vaccine in adults ≥50 years of age: A randomized trial’ [Vaccine 36 (2018) 4278–4286] Open
View article: 1956. Persistence of Immune Response and Safety of an Adjuvanted Recombinant Zoster Vaccine in Older Adults Previously Vaccinated with a Live-Attenuated Herpes Zoster Vaccine: End-of-Study Results of a Phase III, Group-Matched, Clinical Trial
1956. Persistence of Immune Response and Safety of an Adjuvanted Recombinant Zoster Vaccine in Older Adults Previously Vaccinated with a Live-Attenuated Herpes Zoster Vaccine: End-of-Study Results of a Phase III, Group-Matched, Clinical Trial Open
BACKGROUND: Herpes zoster (HZ), caused by reactivation of varicella-zoster virus (VZV), typically manifests as a dermatomal rash and can result in complications, such as postherpetic neuralgia. HZ risk increases with age due to age-related…
View article: Quality of Life Impact of an Adjuvanted Recombinant Zoster Vaccine in Adults Aged 50 Years and Older
Quality of Life Impact of an Adjuvanted Recombinant Zoster Vaccine in Adults Aged 50 Years and Older Open
Background To determine the efficacy of an adjuvanted recombinant zoster vaccine in reducing the herpes zoster (HZ) burden of illness, HZ burden of interference with activities of daily living, and HZ impact on quality of life. Methods The…
View article: Immunogenicity and safety of the adjuvanted recombinant zoster vaccine co-administered with the 23-valent pneumococcal polysaccharide vaccine in adults ≥50 years of age: A randomized trial
Immunogenicity and safety of the adjuvanted recombinant zoster vaccine co-administered with the 23-valent pneumococcal polysaccharide vaccine in adults ≥50 years of age: A randomized trial Open
This study evaluated immunogenicity and safety of the adjuvanted recombinant zoster vaccine (RZV) when the first dose was co-administered with the 23-valent pneumococcal polysaccharide vaccine (PPSV23) in adults aged ≥50 years. In this ope…
View article: Immune Responses to a Recombinant Glycoprotein E Herpes Zoster Vaccine in Adults Aged 50 Years or Older
Immune Responses to a Recombinant Glycoprotein E Herpes Zoster Vaccine in Adults Aged 50 Years or Older Open
NCT01165177; NCT01165229.
View article: Persistence of immune response to an adjuvanted varicella-zoster virus subunit vaccine for up to year nine in older adults
Persistence of immune response to an adjuvanted varicella-zoster virus subunit vaccine for up to year nine in older adults Open
After vaccination with HZ/su, both cell mediated and humoral immunity remained above pre-vaccination levels up to year 9 regardless of age group. Immune responses are predicted to remain above baseline up to 15 years post initial vaccinati…
View article: Complications of herpes zoster in immunocompetent older adults: Incidence in vaccine and placebo groups in two large phase 3 trials
Complications of herpes zoster in immunocompetent older adults: Incidence in vaccine and placebo groups in two large phase 3 trials Open
HZ/su reduces the risk of HZ-associated complications in older adults (NCT01165177; NCT01165229).
View article: Efficacy, Immunogenicity and Safety of adjuvanted Herpes Zoster-Virus Subunit Vaccine Candidates in Adults from 60 Years and older : Results from the Efficacy Studies ZOE-50 and ZOE-70
Efficacy, Immunogenicity and Safety of adjuvanted Herpes Zoster-Virus Subunit Vaccine Candidates in Adults from 60 Years and older : Results from the Efficacy Studies ZOE-50 and ZOE-70 Open
Efficacy, Immunogenicity and Safety of adjuvanted Herpes Zoster-Virus Subunit Vaccine Candidates in Adults from 60 Years and older: Results from the Efficacy Studies ZOE-50 and ZOE-70
View article: Immunogenicity, reactogenicity and safety of 2 doses of an adjuvanted herpes zoster subunit vaccine administered 2, 6 or 12 months apart in older adults: Results of a phase III, randomized, open-label, multicenter study
Immunogenicity, reactogenicity and safety of 2 doses of an adjuvanted herpes zoster subunit vaccine administered 2, 6 or 12 months apart in older adults: Results of a phase III, randomized, open-label, multicenter study Open
Clinicaltrials.gov (NCT01751165).
View article: A randomized lot-to-lot immunogenicity consistency study of the candidate zoster vaccine HZ/su
A randomized lot-to-lot immunogenicity consistency study of the candidate zoster vaccine HZ/su Open
The three HZ/su manufacturing lots demonstrated consistent immunogenicity. No safety concerns were identified. Clinical trial registry number: NCT02075515 (ClinicalTrials.gov).
View article: Immunogenicity and Safety of the HZ/su Adjuvanted Herpes Zoster Subunit Vaccine in Adults Previously Vaccinated With a Live Attenuated Herpes Zoster Vaccine
Immunogenicity and Safety of the HZ/su Adjuvanted Herpes Zoster Subunit Vaccine in Adults Previously Vaccinated With a Live Attenuated Herpes Zoster Vaccine Open
NCT02581410.
View article: Immunogenicity and Safety of an Adjuvanted Herpes Zoster Subunit Vaccine Coadministered With Seasonal Influenza Vaccine in Adults Aged 50 Years or Older
Immunogenicity and Safety of an Adjuvanted Herpes Zoster Subunit Vaccine Coadministered With Seasonal Influenza Vaccine in Adults Aged 50 Years or Older Open
NCT01954251.
View article: Immunogenicity and safety of an adjuvanted herpes zoster subunit candidate vaccine in adults ≥ 50 years of age with a prior history of herpes zoster: A phase III, non-randomized, open-label clinical trial
Immunogenicity and safety of an adjuvanted herpes zoster subunit candidate vaccine in adults ≥ 50 years of age with a prior history of herpes zoster: A phase III, non-randomized, open-label clinical trial Open
This phase III, non-randomized, open-label, multi-center study (NCT01827839) evaluated the immunogenicity and safety of an adjuvanted recombinant subunit herpes zoster (HZ) vaccine (HZ/su) in adults aged ≥ 50 y with prior physician-documen…
View article: Immunogenicity and Safety of an Adjuvanted Herpes Zoster Subunit Vaccine in Older Adults Previously Vaccinated with a Live-Attenuated Herpes Zoster Vaccine: A Phase III, Group-Matched, Clinical Trial
Immunogenicity and Safety of an Adjuvanted Herpes Zoster Subunit Vaccine in Older Adults Previously Vaccinated with a Live-Attenuated Herpes Zoster Vaccine: A Phase III, Group-Matched, Clinical Trial Open
Background Herpes zoster (HZ), caused by reactivation of varicella-zoster virus (VZV), typically manifests as a dermatomal rash and can lead to postherpetic neuralgia (PHN). HZ and PHN risk increase with age. Efficacy against HZ induced by…
View article: Safety and immunogenicity of a Herpes Zoster subunit vaccine in Japanese population aged ≥50 years when administered subcutaneously vs. intramuscularly
Safety and immunogenicity of a Herpes Zoster subunit vaccine in Japanese population aged ≥50 years when administered subcutaneously vs. intramuscularly Open
The impact of alternate routes of vaccine administration, subcutaneous (SC) or intramuscular (IM), on the safety and immunogenicity of herpes zoster subunit candidate vaccine (HZ/su) was assessed in Japanese adults aged ≥ 50 y. During this…
View article: Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older
Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older Open
In our trial, HZ/su was found to reduce the risks of herpes zoster and postherpetic neuralgia among adults 70 years of age or older. (Funded by GlaxoSmithKline Biologicals; ZOE-50 and ZOE-70 ClinicalTrials.gov numbers, NCT01165177 and NCT0…
View article: Randomized, Phase III Clinical Trial to Assess the Immunogenicity and Safety of an Investigational Subunit Adjuvanted Herpes Zoster Vaccine Co-Administered With a Seasonal Quadrivalent-Inactivated Influenza Vaccine in Adults Aged 50 Years and Older
Randomized, Phase III Clinical Trial to Assess the Immunogenicity and Safety of an Investigational Subunit Adjuvanted Herpes Zoster Vaccine Co-Administered With a Seasonal Quadrivalent-Inactivated Influenza Vaccine in Adults Aged 50 Years and Older Open
View article: Efficacy, Immunogenicity and Safety of an Investigational Subunit Adjuvanted Herpes Zoster Vaccine in Adults Aged 60 Years and Older: Results From the ZOE-50 and ZOE-70 Efficacy Studies
Efficacy, Immunogenicity and Safety of an Investigational Subunit Adjuvanted Herpes Zoster Vaccine in Adults Aged 60 Years and Older: Results From the ZOE-50 and ZOE-70 Efficacy Studies Open
View article: Immunogenicity and Safety of 2 Doses of an Investigational Herpes Zoster Subunit Vaccine Administered 2, 6 or 12 Months Apart in Adults 50 Years and Older: Results of a Phase III, Randomized, Open-Label, Multicenter Trial
Immunogenicity and Safety of 2 Doses of an Investigational Herpes Zoster Subunit Vaccine Administered 2, 6 or 12 Months Apart in Adults 50 Years and Older: Results of a Phase III, Randomized, Open-Label, Multicenter Trial Open
Background.Two doses of a candidate herpes zoster (HZ) subunit vaccine (HZ/ su; 50 µg varicella-zoster virus glycoprotein E [gE] and AS01 B Adjuvant System) administered 2 months (mo) apart in adults ≥50 years of age demonstrated >90% effi…
View article: Quality-of-Life Impact of an Investigational Subunit-Adjuvanted Herpes Zoster Vaccine in Adults ≥50 Years of Age
Quality-of-Life Impact of an Investigational Subunit-Adjuvanted Herpes Zoster Vaccine in Adults ≥50 Years of Age Open
View article: Long-term immunogenicity and safety of an investigational herpes zoster subunit vaccine in older adults
Long-term immunogenicity and safety of an investigational herpes zoster subunit vaccine in older adults Open
gE-specific cellular and humoral immune responses persisted for 6 years after two-dose vaccination with HZ/su in healthy older adults. No safety concerns were identified.
View article: Efficacy of an Adjuvanted Herpes Zoster Subunit Vaccine in Older Adults
Efficacy of an Adjuvanted Herpes Zoster Subunit Vaccine in Older Adults Open
The HZ/su vaccine significantly reduced the risk of herpes zoster in adults who were 50 years of age or older. Vaccine efficacy in adults who were 70 years of age or older was similar to that in the other two age groups. (Funded by GlaxoSm…
View article: Efficacy of an Adjuvanted Herpes Zoster Subunit Vaccine in Older Adults by Region: Results of the Phase 3 ZOE-50 Trial
Efficacy of an Adjuvanted Herpes Zoster Subunit Vaccine in Older Adults by Region: Results of the Phase 3 ZOE-50 Trial Open
View article: Persistence of the Immune Response to an Adjuvanted Herpes Zoster Subunit Vaccine in Healthy Older Adults: Modeling of Vaccine-Induced Immune Response, Data From a 6-Year Follow-Up Study
Persistence of the Immune Response to an Adjuvanted Herpes Zoster Subunit Vaccine in Healthy Older Adults: Modeling of Vaccine-Induced Immune Response, Data From a 6-Year Follow-Up Study Open
View article: Reactogenicity of an Adjuvanted Herpes Zoster Subunit Vaccine in Older Adults: Results of the Phase 3 ZOE-50 Trial
Reactogenicity of an Adjuvanted Herpes Zoster Subunit Vaccine in Older Adults: Results of the Phase 3 ZOE-50 Trial Open