Primary objectivesImmunogenicityTo demonstrate that a second dose of ZOSTAVAX® elicits higher varicella-zoster virus (VZV) antibody titres than a first dose of ZOSTAVAX® whether given as a 0-1 month schedule or as a 0-3 month schedule in subjects…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary objectives
Immunogenicity
To demonstrate that a second dose of ZOSTAVAX® elicits higher varicella-zoster
virus (VZV) antibody titres than a first dose of ZOSTAVAX® whether given as a
0-1 month schedule or as a 0-3 month schedule in subjects >=70 years of age as
measured at 4 weeks post-vaccination
Secondary outcome
Secondary Objectives
Immunogenicity
• To summarise the VZV antibody titres 4 weeks post-vaccination after a 1-dose
regimen and 4 weeks post-vaccination after each dose of each 2-dose regimen of
ZOSTAVAX® administered to subjects >=70 years of age
• To compare the VZV antibody titres at 12 months after completion of a 1-dose
regimen with the VZV antibody titres at 12 months after completion of each
2-dose regimen of ZOSTAVAX® administered to subjects >=70 years of age
• To summarise the VZV antibody titres annually at 24 and 36 months after
completion of a 1-dose regimen and at 24 and 36 months after completion of each
2-dose regimen of ZOSTAVAX® administered to subjects >=70 years of age
Safety
• To assess the safety profile of a 1-dose regimen and the safety profile of
each 2-dose regimen of ZOSTAVAX® administered to subjects >=70 years of age
Background summary
PAge 16-17 of the protocol
Study objective
Primary objectives
Immunogenicity
To demonstrate that a second dose of ZOSTAVAX® elicits higher varicella-zoster
virus (VZV) antibody titres than a first dose of ZOSTAVAX® whether given as a
0-1 month schedule or as a 0-3 month schedule in subjects >=70 years of age as
measured at 4 weeks post-vaccination
Secondary Objectives
Immunogenicity
• To summarise the VZV antibody titres 4 weeks post-vaccination after a 1-dose
regimen and 4 weeks post-vaccination after each dose of each 2-dose regimen of
ZOSTAVAX® administered to subjects >=70 years of age
• To compare the VZV antibody titres at 12 months after completion of a 1-dose
regimen with the VZV antibody titres at 12 months after completion of each
2-dose regimen of ZOSTAVAX® administered to subjects >=70 years of age
• To summarise the VZV antibody titres annually at 24 and 36 months after
completion of a 1-dose regimen and at 24 and 36 months after completion of each
2-dose regimen of ZOSTAVAX® administered to subjects >=70 years of age
Safety
• To assess the safety profile of a 1-dose regimen and the safety profile of
each 2-dose regimen of ZOSTAVAX® administered to subjects >=70 years of age
Study design
This is an open-label, randomised, comparative, multi-centre study with 3
groups
Intervention
Randomisation will be done using a 1:1:1 ratio in 3 groups as follows:
Group 1: ZOSTAVAX® at Day 0 only
Group 2: ZOSTAVAX® at Day 0 and Month 1 (Day 28 to Day 35)
Group 3: ZOSTAVAX® at Day 0 and Month 3 (Day 82 to Day 98)
Study burden and risks
According to the clinical development programme of Zostavax®, some very common
adverse events, i.e. occurrence equal or greater to 1 case in 10
administrations, are erythema, pain/tenderness and swelling at injection site.
Other events occurring for more than 1 case in 100 administrations but less
than 1 case in 10 administrations are haematoma, itching (i.e. pruritus),
warmth at injection site and headache.
As with any vaccination, there is a rare possibility of an allergic reaction.
This may cause a severe narrowing of the air passages and breathing
difficulties.
Additionally, taking blood samples may be associated with some inconveniences,
such as slight pain and bruises from needle punctures.
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Frankrijk
Listed location countries
Age
Inclusion criteria
70 years or older, varicella history-positive or residence for > 30 years in a country with endemic VZV infection
Exclusion criteria
Febrile within the last 72 hours before vaccination, history of hypersensitivity/anaphylactoid reaction to ZOSTAVAX components including gelatine or neomycin, prior herpes-zoster episode clinically diagnosed by a physician
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-000744-28-NL |
| CCMO | NL18285.000.07 |