A Partially Blinded Randomized Clinical Trial to Study the Immunogenicity and Safety of Intradermal Administration of ZOSTAVAX™ (V211)

NCT01385566 Phase 1 COMPLETED Results posted

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

Details

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 1
Status	COMPLETED
Enrolment	223
Start date	2011-09
Completion	2013-05

Conditions

• Herpes Zoster

Interventions

• ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Subcutaneous
• ZOSTAVAX™ (Zoster Vaccine Live) 1/3 Dose Subcutaneous
• ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Intradermal
• ZOSTAVAX™ (Zoster Vaccine Live) Partial Doses Intradermal
• Full Dose Intradermal Placebo
• Intradermal Placebo

Primary outcomes

• Geometric Mean Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Antibodies — Baseline and 6 weeks following vaccine administration
  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.
• Number of Participants Reporting an Adverse Experience (AE) — Up to 42 days following vaccine administration
  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.
• Number of Participants Reporting a Serious Adverse Experience (SAE) — Up to 42 days following vaccine administration
  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.
• Number of Participants Reporting a Serious Adverse Experience — Within 5 days after the blood draw at approximately 20 months following vaccine administration
  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
• Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) — Up to 5 days following vaccine administration
  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.
• Number of Participants Reporting Systemic Adverse Experiences — Up to 42 days following vaccine administration
  Systemic AEs included all reported AEs except injection-site AEs