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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01385566
Other study ID # V211-051
Secondary ID
Status Completed
Phase Phase 1
First received June 28, 2011
Last updated September 11, 2015
Start date September 2011
Est. completion date May 2013

Study information

Verified date September 2015
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This study will compare the safety and immunogenicity of ZOSTAVAX™ (V211) administered both intradermally and subcutaneously at various doses.


Description:

This is an exploratory, randomized, partially blinded, multicenter clinical study designed to compare safety and biomarkers of varicella zoster virus immunogenicity when administering ZOSTAVAX™ (V211) at various doses both intradermally and subcutaneously in healthy male and female participants 50 years of age and older.


Recruitment information / eligibility

Status Completed
Enrollment 223
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 50 Years and older
Eligibility Inclusion Criteria:

- Prior history of varicella (chickenpox) or residence in a country with endemic varicella zoster virus infection for at least 30 years

- Temperature less than 100.4 °F on day of vaccination

- Female participants of reproductive potential must have a negative pregnancy test and agree to remain abstinent or use two acceptable contraceptive methods for 3 months postvaccination

- In good health

Exclusion Criteria:

- History of hypersensitivity reaction to any vaccine component, including gelatin or neomycin

- Household exposure to pregnant women who have not had chickenpox and have not been vaccinated against varicella or to immunosuppressed/immunodeficient individuals

- Household or workplace exposure to children 18 months and younger who have not been vaccinated against varicella

- Prior history of herpes zoster

- Prior receipt of any varicella or zoster vaccine

- Received or is expected to receive immune globulin and/or blood products from 5 months prior to randomization through 42 days after vaccination

- On immunosuppressive therapy

- Known or suspected immune dysfunction

- Received a live virus vaccine or is scheduled to receive a live virus vaccine from 4 weeks prior to study vaccination through the completion of all study visits

- Received any inactivated vaccine or is scheduled to receive any inactivated vaccine from 7 days prior to study vaccination through 7 days postvaccination, except for inactivated influenza vaccine

- Not ambulatory

- Pregnant or breastfeeding

- Use of nontopical antiviral therapy with activity against herpes viruses

- Active untreated tuberculosis

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Subcutaneous
One 0.65 mL injection subcutaneously on Day 1
ZOSTAVAX™ (Zoster Vaccine Live) 1/3 Dose Subcutaneous
One approximately 0.22 mL injection subcutaneously on Day 1
ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Intradermal
Two intradermal injections of approximately 0.15 mL each on Day 1
ZOSTAVAX™ (Zoster Vaccine Live) Partial Doses Intradermal
One intradermal injection of approximately 0.1 mL on Day 1
Full Dose Intradermal Placebo
Two intradermal placebo injections of approximately 0.15 mL each on Day 1
Intradermal Placebo
One intradermal placebo injection of approximately 0.1 mL on Day 1

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type Measure Description Time frame Safety issue
Primary Geometric Mean Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Antibodies VZV antibody titers were measured by glycoprotein enzyme-linked immunosorbent assay at baseline and at 6 weeks after vaccine administration. The geometric mean fold change represents the 6-week value / the baseline value. Baseline and 6 weeks following vaccine administration No
Primary Number of Participants Reporting an Adverse Experience (AE) An AE is defined as any unfavorable and unintended change in the
structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience.
Up to 42 days following vaccine administration Yes
Primary Number of Participants Reporting a Serious Adverse Experience (SAE) An SAE is any adverse experience that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect in offspring of a study participant, is a cancer, or is another important medical event when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention. Up to 42 days following vaccine administration Yes
Primary Number of Participants Reporting a Serious Adverse Experience An SAE is any adverse experience that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect in offspring of a study participant, is a cancer, or is another important medical event when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention Within 5 days after the blood draw at approximately 20 months following vaccine administration Yes
Primary Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) The VRC actively prompts for local injection-site AEs of redness, swelling, and pain/tenderness and for the size of local injection-site reactions of redness and swelling that occur within 5 days of vaccination. The presence of varicella/varicella-like rash and herpes zoster/herpes zoster-like rash is also captured on the VRC. Participants receiving an injection in both limbs will be instructed to complete injection-site reaction information for each limb. All injection-site AEs were reported for the limb in which they occurred: V211 vaccine or placebo. Up to 5 days following vaccine administration Yes
Primary Number of Participants Reporting Systemic Adverse Experiences Systemic AEs included all reported AEs except injection-site AEs Up to 42 days following vaccine administration Yes
Primary Number of Participants Reporting a Non-injection-site Rash (Varicella, Varicella-like, Herpes Zoster, or Herpes Zoster-like) Non-injection-site rashes were examined by a study physician. Rashes suspected to be varicella/varicella-like or herpes zoster/herpes zoster-like were sampled for verification by polymerase chain reaction. Up to 42 days following vaccine administration Yes
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