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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
473
0.65 mL injection Zoster Vaccine, Live, (Oka-Merck) over 4 week vaccination period
Pneumococcal Vaccine, Polyvalent (23-valent) 0.5 mL Placebo injection over 4 week vaccination period.
Pneumococcal Vaccine, Polyvalent (23-valent) 0.5 mL injection over 4 week vaccination period.
Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination
GMT of the VZV antibody responses at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly. \*gpELISA = glycoprotein enzyme-linked immunosorbent assay
Time frame: 4 weeks postvaccination
Geometric Mean Fold Rise (GMFR) of the Varicella-zoster Virus (VZV) Antibody Responses From Day 1 to 4 Weeks Postvaccination.
GMFR of the VZV antibody response from prevaccination to Week 4 postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23. gpELISA = glycoprotein enzyme-linked immunosorbent assay.
Time frame: Four weeks postvaccination
Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 3 Antibody Response at 4 Weeks Postvaccination.
GMT of the PnPs serotype 3 antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly.
Time frame: Four weeks postvaccination
Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 14 Antibody Response at 4 Weeks Postvaccination.
GMT of the PnPs serotype 14 antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly.
Time frame: Four weeks postvaccination
Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 19A Antibody Response at 4 Weeks Postvaccination.
GMT of the PnPs serotype 19A antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly.
Time frame: Four weeks postvaccination
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Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 22F Antibody Response at 4 Weeks Postvaccination.
GMT of the PnPs serotype 22F antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly.
Time frame: Four weeks postvaccination
Safety and Tolerability of Both Vaccines When Administered Concomitantly.
All adverse events were analyzed including serious adverse events; injection-site adverse events; Vaccination Report Card prompted systemic adverse events, including varicella-like rashes or herpes zoster-like rashes; all other systemic adverse events.
Time frame: Eight weeks postvaccination