Phase 3
N=759
Immunogenicity and Safety of a 1-dose Regimen of a Zoster Vaccine Versus Different 2-dose Regimens in Participants ≥ 70 Years of Age. (V211-043)
Prevention of : Herpes-Zoster
Bottom Line
View on ClinicalTrials.gov: NCT00561080 ↗Enrolled (actual)
759
Serious AEs
2.5%
Results posted
Dec 2017
Primary outcome: Primary: Geometric Mean Titer (GMT) of Varicella Zoster Virus (VZV) Antibodies 4 Weeks After Each Vaccination: Groups 2 and 3 — 498.8; 523.3; 555.3; 410.5 gpELISA units/mL — p=0.948
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Zostavax (Biological)
- Age
- Older Adult · 70+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titer (GMT) of Varicella Zoster Virus (VZV) Antibodies 4 Weeks After Each Vaccination: Groups 2 and 3 |
498.8; 523.3; 555.3; 410.5 | 0.948 |
| SECONDARY Geometric Mean Titer (GMT) of VZV Antibodies 4 Weeks After Vaccination: Group 1 |
233.7; 550.0 | — |
| SECONDARY Geometric Mean Fold Rise (GMFR) in VZV Antibody Titres From Pre-vaccination to 4 Weeks Post-dose 1 in Groups 1, 2 and 3 and 4 Weeks Post-dose 2 in Groups 2 and 3 |
2.35; 2.37; 2.29; NA; 2.64; 1.80 | — |
| SECONDARY Geometric Mean Titre of VZV Antibodies 12 Months Post-last Dose |
246.8; 261.1; 266.6 | — |
| SECONDARY Geometric Mean Fold Rise (GMFR) in VZV Antibody Titres From Pre-Vaccination To 12 Months Post-dose 1 in Group 1 And From Pre-Vaccination To 12 Months Post-dose 2 in Groups 2 and 3 |
1.06; 1.16; 1.17 | — |
| SECONDARY Geometric Mean Titre (GMT) of VZV Antibodies 24 and 36 Months Post-dose 1 in Group 1 and the 24 and 36 Months Post-dose 2 in Groups 2 and 3 |
— | — |
| SECONDARY Geometric Mean Fold Rise (GMFR) in VZV Antibody Titres From Pre-Vaccination To 24 And 36 Months Post-dose 1 in Group 1 and From Pre-vaccination To 24 And 36 Months Post-dose 2 in Groups 2 and 3 |
— | — |
| SECONDARY Percentage of Participants Who Reported a Solicited Injection Site Reaction : Post-dose 1 |
47.2; 46.0; 42.2 | — |
| SECONDARY Percentage of Participants Who Reported a Solicited Injection Site Reaction: Post-dose 2 |
42.2; 42.1 | — |
| SECONDARY Percentage of Participants Who Reported an Unsolicited Injection Site Reaction: Post-dose 1 |
5.6; 4.8; 0.8 | — |
| SECONDARY Percentage of Participants Who Reported an Unsolicited Injection Site Reaction: Post-dose 2 |
1.3; 3.2 | — |
| SECONDARY Percentage of Participants Who Reported Herpes Zoster or Zoster-like Rash: Post-dose 1 |
0.8; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants Who Reported Herpes Zoster or Zoster-like Rash: Post-Dose 2 |
0.0; 0.0 | — |
| SECONDARY Percentage of Participants Who Reported Varicella or Varicella-like Rash: Post-dose 1 |
0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants Who Reported Varicella or Varicella-like Rash: Post-dose 2 |
0.4; 0.5 | — |
| SECONDARY Percentage of Participants Who Reported a Systemic Adverse Event: Post-dose 1 |
25.8; 32.7; 25.7 | — |
| SECONDARY Percentage of Participants Who Reported a Systemic Adverse Event: Post-dose 2 |
20.7; 15.4 | — |
| SECONDARY Percentage of Participants Who Reported a Vaccine-related Systemic Adverse Event: Post-dose 1 |
6.7; 4.0; 8.4 | — |
| SECONDARY Percentage of Participants Who Reported a Vaccine-related Systemic Adverse Event: Post-dose 2 |
3.4; 2.7 | — |
| SECONDARY Percentage of Participants Who Reported a Serious Adverse Event: Post-dose 1 |
0.4; 2.8; 0.4 | — |
| SECONDARY Percentage of Participants Who Reported a Serious Adverse Event: Post-dose 2 |
0.9; 0.9 | — |
| SECONDARY Percentage of Participants Who Reported a Vaccine-related Serious Adverse Event |
0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants Who Died During the Study |
1.6; 2.0; 1.2 | — |
Summary
Primary objective:
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 at 4 weeks post-vaccination after a 1-dose regimen and 4 weeks post-vaccination after each dose of each 2-doses regimen of ZOSTAVAX®.
* 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-doses regimen of ZOSTAVAX®
* To summarise the VZV antibody titres at 24 and 36 months after completion of a 1-dose regimen and at 24 and 36 months after completion of each 2-doses regimen of ZOSTAVAX®
Eligibility Criteria
Inclusion Criteria
- Age ≥ 70 years
- Varicella history-positive or residence for > 30 years in a country with endemic VZV infection
- Signed informed consent form prior to any study procedure
Exclusion Criteria
- Febrile illness within the last 72 hours before the first vaccination
- Prior herpes-zoster episode clinically diagnosed by a physician
- Prior receipt of varicella or zoster vaccine
- Exposure to varicella or herpes-zoster within the 4 weeks prior to the first vaccination
- Significant underlying illness preventing completion of the study vaccination schedules,
- Known active tuberculosis,
- Immune deficiency disorder, including active neoplastic disease within the prior 5 years,
- Immune function impairment caused by medical condition or immunosuppressive therapy, or any other cause,
- Receipt of any inactivated vaccine within the 2 weeks prior to the first vaccination,
- Receipt of any other live vaccine within the 4 weeks prior to the first vaccination,
- Receipt of immunoglobulins or blood-derived products within the 5 months prior to the first vaccination,
- Concomitant use of non-topical antiviral therapy
Data sourced from ClinicalTrials.gov (NCT00561080). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.