Phase 3
N=473
ZOSTAVAX™ Administered Concomitantly With PNEUMOVAX™ 23 (V211-012)(COMPLETED)
Herpes Zoster · Pneumococcal Infection
Bottom Line
View on ClinicalTrials.gov: NCT00535730 ↗Enrolled (actual)
473
Serious AEs
—
Results posted
May 2009
Primary outcome: Primary: Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination — 448.5; 371.6 gpELISA units*/mL — p=0.244
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Zoster Vaccine, Live, (Oka-Merck), ZOSTAVAX™ (Biological); Comparator: placebo (concomitant-vaccine matched) (Biological); Pneumococcal Vaccine, Polyvalent (23-valent), PNEUMOVAX™ 23 (Biological)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination |
448.5; 371.6 | 0.244 |
| PRIMARY Geometric Mean Fold Rise (GMFR) of the Varicella-zoster Virus (VZV) Antibody Responses From Day 1 to 4 Weeks Postvaccination. |
1.9 | <0.001 sig |
| PRIMARY Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 3 Antibody Response at 4 Weeks Postvaccination. |
1.2; 1.1 | <0.001 sig |
| PRIMARY Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 14 Antibody Response at 4 Weeks Postvaccination. |
26.5; 25.7 | <0.001 sig |
| PRIMARY Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 19A Antibody Response at 4 Weeks Postvaccination. |
10.5; 10.5 | <0.001 sig |
| PRIMARY Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 22F Antibody Response at 4 Weeks Postvaccination. |
2.8; 2.5 | <0.001 sig |
| SECONDARY Safety and Tolerability of Both Vaccines When Administered Concomitantly. |
141; 136; 74; 70; 4; 2 | — |
Summary
The purpose of this study is to determine whether Zoster Vaccine Live and Pneumococcal Vaccine, polyvalent are as well tolerated and immunogenic when the vaccines are given together (in different body sites), as when they are given alone, in adults 60 years of age and older.
Eligibility Criteria
Inclusion Criteria
- 60 years of age or older
- Stable underlying conditions
- Postmenopausal if female
- Afebrile
Exclusion Criteria
- Previously vaccinated with either vaccine
- Immune deficiency
- History of allergy to components in either vaccine
- Concomitant antiviral therapy
Data sourced from ClinicalTrials.gov (NCT00535730). 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.