Herpes Zoster
Conditions
Keywords
Prevention of Herpes Zoster
Brief summary
The purpose of this study is to determine whether the investigational zoster vaccine has a comparable immune response (the body's ability to protect against disease) and safety profile when given concomitantly with another vaccine.
Interventions
BIOLOGICALZOSTAVAX™ (concomitant)
a single administration of 0.65 mL subcutaneous injection of zoster vaccine live on Day 1 and placebo at Week 4
BIOLOGICALComparator: Influenza Vaccine
a single administration of 0.5 mL intramuscular injection of influenza vaccine (inactivated) at Day 1
BIOLOGICALZOSTAVAX™ (Nonconcomitant)
Placebo injection on Day 1 and a single administration of 0.65 mL subcutaneous injection of zoster vaccine live at Week 4
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults 50 years of age or older
Exclusion criteria
* Prior history of Herpes Zoster (shingles) * Prior receipt of varicella or zoster vaccine * Immunosuppressed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody Responses | 4 weeks | The Geometric mean titer (GMT) of the VZV glycoprotein enzyme-linked immunosorbent assay (gpELISA) antibody responses at Week 4 postvaccination in participants who received ZOSTAVAX™ concomitantly with influenza vaccine was compared to that in subjects who received influenza vaccine and ZOSTAVAX™ nonconcomitantly. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Fold Rise (GMFR) in VZV gpELISA Antibody Titers From Prevaccination to 4 Weeks Postvaccination | prevaccination to 4 weeks postvaccination | GMFR of the VZV gpELISA antibody titers from prevaccination to 4 weeks postvaccination when ZOSTAVAX™ is administered concomitantly with influenza vaccine |
| Geometric Mean Titers (GMTs) of H1N1 Strain Antibody Responses at 4 Weeks Postvaccination | 4 weeks postvaccination | GMT of the H1N1 strain antibody responses at 4 weeks postvaccination in participants who receive ZOSTAVAX™ concomitantly with influenza vaccine and those who receive ZOSTAVAX™ and influenza vaccine nonconcomitantly |
| GMTs of H3N2 Strain Antibody Responses at 4 Weeks Postvaccination | 4 weeks postvaccination | GMT of the H3N2 strain antibody responses at 4 weeks postvaccination in participants who receive ZOSTAVAX™ concomitantly with influenza vaccine and those who receive ZOSTAVAX™ and influenza vaccine nonconcomitantly |
| GMTs of B Strain Antibody Responses at 4 Weeks Postvaccination | 4 weeks postvaccination | GMT of the B strain antibody responses at 4 weeks postvaccination in participants who receive ZOSTAVAX™ concomitantly with influenza vaccine and those who receive ZOSTAVAX™ and influenza vaccine nonconcomitantly |
Participant flow
Recruitment details
Participants were recruited at 13 sites in the United States and 7 sites in Europe. First Patient In (FPI): 23-SEP-2005; Last Patient Last Visit (LPLV): 08-MAR-2006
Participants by arm
| Arm | Count |
|---|---|
| Concomitant Group ZOSTAVAX™ 0.65 mL subcutaneous (SC) injection administered concomitantly with 0.5 mL intramuscular (IM) influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4 | 382 |
| Nonconcomitant Group Influenza vaccine 0.5 mL IM injection administerd with placebo injection on Day 1 and ZOSTAVAX™ 0.65 mL SC injection at Week 4 | 380 |
| Total | 762 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 8 | 5 |
| Overall Study | Other | 2 | 1 |
| Overall Study | Protocol Violation | 2 | 3 |
| Overall Study | Withdrawal by Subject | 3 | 3 |
Baseline characteristics
| Characteristic | Total | Concomitant Group | Nonconcomitant Group |
|---|---|---|---|
| Age, Continuous | 63.5 years STANDARD_DEVIATION 8.11 | 63.4 years STANDARD_DEVIATION 7.99 | 63.6 years STANDARD_DEVIATION 8.24 |
| Race/Ethnicity, Customized African | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized Asian | 9 participants | 5 participants | 4 participants |
| Race/Ethnicity, Customized Black | 206 participants | 106 participants | 100 participants |
| Race/Ethnicity, Customized Hispanic American | 22 participants | 11 participants | 11 participants |
| Race/Ethnicity, Customized Indian | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Multiracial | 2 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized Native American | 2 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized White | 519 participants | 258 participants | 261 participants |
| Sex: Female, Male Female | 427 Participants | 215 Participants | 212 Participants |
| Sex: Female, Male Male | 335 Participants | 167 Participants | 168 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 199 / 378 | 181 / 376 |
| serious Total, serious adverse events | 6 / 378 | 5 / 376 |
Outcome results
Primary
Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody Responses
The Geometric mean titer (GMT) of the VZV glycoprotein enzyme-linked immunosorbent assay (gpELISA) antibody responses at Week 4 postvaccination in participants who received ZOSTAVAX™ concomitantly with influenza vaccine was compared to that in subjects who received influenza vaccine and ZOSTAVAX™ nonconcomitantly.
Time frame: 4 weeks
Population: The primary analysis was based on the per protocol population defined as participants who had valid GMT results from samples obtained within the prespecified day ranges at Day 1, at Week 4, or at Week 8 postvaccination, and who did not meet any of the protocol violations prespecified in the statistical analysis plan (SAP).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Concomitant Group | Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody Responses | 553.5 gpELISA units/mL |
| Nonconcomitant Group | Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody Responses | 588.7 gpELISA units/mL |
Other Pre-specified
Geometric Mean Fold Rise (GMFR) in VZV gpELISA Antibody Titers From Prevaccination to 4 Weeks Postvaccination
GMFR of the VZV gpELISA antibody titers from prevaccination to 4 weeks postvaccination when ZOSTAVAX™ is administered concomitantly with influenza vaccine
Time frame: prevaccination to 4 weeks postvaccination
Population: The analysis was based on the per protocol population defined as participants who had valid GMFR results from samples obtained within the prespecified day ranges at Day 1, at Week 4, or at Week 8 postvaccination, and who did not meet any of the protocol violations prespecified in the statistical analysis plan (SAP)
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Concomitant Group | Geometric Mean Fold Rise (GMFR) in VZV gpELISA Antibody Titers From Prevaccination to 4 Weeks Postvaccination | 2.1 ratio |
Other Pre-specified
Geometric Mean Titers (GMTs) of H1N1 Strain Antibody Responses at 4 Weeks Postvaccination
GMT of the H1N1 strain antibody responses at 4 weeks postvaccination in participants who receive ZOSTAVAX™ concomitantly with influenza vaccine and those who receive ZOSTAVAX™ and influenza vaccine nonconcomitantly
Time frame: 4 weeks postvaccination
Population: The analysis was based on the per protocol population defined as participants who had valid results from samples obtained within the prespecified day ranges at Day 1, at Week 4, or at Week 8 postvaccination, and who did not meet any of the protocol violations prespecified in the SAP.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Concomitant Group | Geometric Mean Titers (GMTs) of H1N1 Strain Antibody Responses at 4 Weeks Postvaccination | 122.9 titers |
| Nonconcomitant Group | Geometric Mean Titers (GMTs) of H1N1 Strain Antibody Responses at 4 Weeks Postvaccination | 134.2 titers |
Other Pre-specified
GMTs of B Strain Antibody Responses at 4 Weeks Postvaccination
GMT of the B strain antibody responses at 4 weeks postvaccination in participants who receive ZOSTAVAX™ concomitantly with influenza vaccine and those who receive ZOSTAVAX™ and influenza vaccine nonconcomitantly
Time frame: 4 weeks postvaccination
Population: The analysis was based on the per protocol population defined as participants who had valid results from samples obtained within the prespecified day ranges at Day 1, at Week 4, or at Week 8 postvaccination, and who did not meet any of the protocol violations prespecified in the SAP
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Concomitant Group | GMTs of B Strain Antibody Responses at 4 Weeks Postvaccination | 119.8 titers |
| Nonconcomitant Group | GMTs of B Strain Antibody Responses at 4 Weeks Postvaccination | 136.5 titers |
Other Pre-specified
GMTs of H3N2 Strain Antibody Responses at 4 Weeks Postvaccination
GMT of the H3N2 strain antibody responses at 4 weeks postvaccination in participants who receive ZOSTAVAX™ concomitantly with influenza vaccine and those who receive ZOSTAVAX™ and influenza vaccine nonconcomitantly
Time frame: 4 weeks postvaccination
Population: The analysis was based on the per protocol population defined as participants who had valid results from samples obtained within the prespecified day ranges at Day 1, at Week 4, or at Week 8 postvaccination, and who did not meet any of the protocol violations prespecified in the SAP.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Concomitant Group | GMTs of H3N2 Strain Antibody Responses at 4 Weeks Postvaccination | 162.7 titers |
| Nonconcomitant Group | GMTs of H3N2 Strain Antibody Responses at 4 Weeks Postvaccination | 150.5 titers |