The objective of the study is to evaluate the general safety of ZOSTAVAX* in subjects >=60 years of age.
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The proportion of subjects reporting serious clinical adverse experiences
through Day 42 postvaccination.
Secondary outcome
The proportion of subjects reporting serious clinical adverse experiences
during the entire 6-month postvaccination
follow-up period.
Background summary
The purpose of the current study is to accumulate additional safety data on the
administration of ZOSTAVAX* in subjects >=60 years of age. This will be done by
evaluating the relative risk of developing serious clinical adverse experiences
for 42 days and 6 months postvaccination in subjects who receive ZOSTAVAX* and
those who receive placebo.
In previous clinical studies, including the Protocol 004 (Shingles Prevention
Study), the safety, efficacy, and immunogenicity of ZOSTAVAX* were evaluated in
subjects >=60 years of age. Protocol 004 demonstrated that ZOSTAVAX* is highly
efficacious in preventing HZ and its complications, and that the benefit of
vaccination persists through 4 years of follow-up in subjects 60 years of age
and older. Furthermore the data from that study showed that the relative risk
of developing one or more Serious Adverse Experiences was somewhat lower in
the subjects 70 to 79 years of age (0.87 vs. 1.12 for ubjects 60 to 69 years
of age and 1.36 for subjects >=80 years of age). To further investigate this
observation, the current study will be stratified to target an enrollment of
15% of subjects >=80 years of age.
Study objective
The objective of the study is to evaluate the general safety of ZOSTAVAX* in
subjects >=60 years of age.
Study design
This study is a randomized, double-blind (with in-house blinding procedures),
placebocontrolled multicenter trial to evaluate the general safety of ZOSTAVAX*
in subjects >=60 years of age. Approximately 12,000 subjects will be randomized
in a 1:1 ratio to receive a single dose of either ZOSTAVAX* or placebo.
Enrollment will be stratified by subject age (with a target of 85% of subjects
60 to 79 years of age and 15% of subjects >=80 years of age).
Subjects will be followed for serious clinical adverse experiences for 42 days
postvaccination (primary safety period) and for 6 months postvaccination by
telephone contact (secondary safety period). Subjects will be educated and
instructed to call the study site immediately, at any time during the study, if
they experience a clinical adverse experience that results in a
hospitalization, prolongs a hospitalization, is a cancer or an overdose, or is
another severe, unexpected, or life-threatening event that could potentially be
considered serious.
Subjects will also be called by the study staff at 6 weeks, 4 months, and 6
months postvaccination, using a prespecified telephone script, to determine if
the subject had a previously-unreported clinical adverse experience that met
one or
more criteria for a serious adverse experience.
Intervention
ZOSTAVAX* or placebo will be administered as a ~0.65-mL subcutaneous injection,
preferably in the deltoid region of the nondominant arm.
Study burden and risks
Subjects will be seen by the investigator once for vaccination with the study
medication. Subsequently, subjects will be asked to call the investigator when
they experience a possible Serious Adverse Event. Subjects are phoned by the
investigator as well after 4 weeks, 4 months and 6 months, to ensure that all
Serious Adverse Events are recorded.
In previous clinical trials with Zostavax, the following most common adverse
experiences were observed: injection-site adverse experiences, such as redness,
swelling, pain/sensitivity, itching, bruising, warmth; headache; rash
resembling chicken pox.
One Merck Drive, P.O. Box 100
Whitehouse Station, NJ, 08889-0100
USA
One Merck Drive, P.O. Box 100
Whitehouse Station, NJ, 08889-0100
USA
Listed location countries
Age
Inclusion criteria
(see protocol page 20 for complete text of criteria);- Age >=60 Years
- Signed informed consent form
- Afebrile on day of vaccination
- Females must be postmenopausal or have negative pregnancy test
Exclusion criteria
(see protocol page 20 for complete text of criteria);1. A history of allergic reaction to any vaccine component
2. Prior receipt of any varicella or zoster vaccine.
3. Any live virus vaccine administered within 4 weeks prevaccination or scheduled
during the 42-day postvaccination period.
4. Any inactivated vaccine, except for influenza vaccine, administered within 7 days
prevaccination or scheduled during the 42-day postvaccination period
5. Subject is pregnant or breastfeeding.
6. Participation in an investigational drug or vaccine study within the last 30 days prior to enrollment or expected during the 42-day postvaccination period.
7. An intercurrent illness (including active untreated tuberculosis) that might interfere with the interpretation of the study
8. Use of immunosuppressive therapy.
9. Known or suspected immune dysfunction that is caused by a medical condition or any other cause. Subjects with a history of cancer who are not on active treatment and are not thought to be immunosuppressed at enrollment will be eligible for enrollment.
10. Any concomitant use of nontopical antiviral therapy with activity against
herpesviruses.
11. Any other reason that in the opinion of the investigator might interfere with the
evaluation required by the study.
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 | EUCTR2007-000343-10-NL |
| CCMO | NL19058.000.07 |