Influenza Herpes Zoster
Conditions
Interventions
Trade Name: Shingrix, GSK
Pharmaceutical Form: Concentrate and solvent for solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Int
Sponsors
Radboudumc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Healthy • Age between 18-35 years old OR age =65 years old • Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: • Known allergy to (components of) the influenza or herpes zoster vaccine • Immunocompromised subjects • Previous herpes zoster vaccination in the last year • Receipt of any vaccination 1 month prior to the start of the study or plans to receive any other vaccination until the last study visit • Chronic use of systemic drugs other than oral contraceptives • Use of NSAIDS less than 4 weeks prior to the start of the study • Acute or active illness within two weeks prior to the start of the study • Pregnant, breastfeeding or planning to become pregnant within the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to identify immune senescence related pathways leading to different immunogenicity after administration of unadjuvanted influenza or AS01 adjuvanted herpes zoster vaccines;Secondary Objective: Not applicable;Primary end point(s): Functional assessment of vaccine response (including but not limited to antibody responses, cellular mediated imune responses, cross-omics, cytokine production);Timepoint(s) of evaluation of this end point: At different timepoints depending on study arm Group 1 (young adults, HZV): D0, D1, D7, D60, D61, D67, D120, D240 Group 2 (older adults, HZV): D0, D1, D7, D60, D61, D67, D120, D240 Group 3 (young adults, QIV): D0, D1, D7, D60, D180 Group 4 (older adults, QIV): D0, D1, D7, D60, D180 Group 5 (young adults, HZV related placebo): D0, D60, D120, D240 Group 6 (young adults, QIV related placebo): D0, D60, D180 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety data (solicited AEs, unsolicited AEs, SAEs, MAAEs, AESIs, AEs leading to withdrawal from the study and unintentional exposure during pregnancy);Timepoint(s) of evaluation of this end point: After the last subject's last visit (6 months after last injection) | — |
Countries
Netherlands
Contacts
Public ContactJaap ten Oever
Radboudumc
Outcome results
None listed