ZOSTAVAX™ Administered Concomitantly With PNEUMOVAX™ 23 (V211-012)(COMPLETED)

NCT00535730 | Completed Phase 3 Results

• 2 other identifiers: V211-0122007_592
• Study Type: interventional
• Target: 473
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Herpes Zoster; Pneumococcal Infection

Outcome Measures

Primary Outcomes (6)

• 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

  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.

  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.

  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.

  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.

  Four weeks postvaccination

• 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.

  Four weeks postvaccination

Secondary Outcomes (1)

• Safety and Tolerability of Both Vaccines When Administered Concomitantly.

  Eight weeks postvaccination

Study Arms (2)

1

PLACEBO COMPARATOR

Placebo Comparator

Biological: Zoster Vaccine, Live, (Oka-Merck), ZOSTAVAX™; Biological: Comparator: placebo (concomitant-vaccine matched)

2

EXPERIMENTAL

vaccine

Biological: Zoster Vaccine, Live, (Oka-Merck), ZOSTAVAX™; Biological: Pneumococcal Vaccine, Polyvalent (23-valent), PNEUMOVAX™ 23

Interventions

Zoster Vaccine, Live, (Oka-Merck), ZOSTAVAX™ BIOLOGICAL

0.65 mL injection Zoster Vaccine, Live, (Oka-Merck) over 4 week vaccination period

Also known as: ZOSTAVAX™

1; 2

Comparator: placebo (concomitant-vaccine matched) BIOLOGICAL

Pneumococcal Vaccine, Polyvalent (23-valent) 0.5 mL Placebo injection over 4 week vaccination period.

1

Pneumococcal Vaccine, Polyvalent (23-valent), PNEUMOVAX™ 23 BIOLOGICAL

Pneumococcal Vaccine, Polyvalent (23-valent) 0.5 mL injection over 4 week vaccination period.

Also known as: PNEUMOVAX™ 23

2

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Stable underlying conditions
• Postmenopausal if female
• Afebrile

You may not qualify if:

• Previously vaccinated with either vaccine
• Immune deficiency
• History of allergy to components in either vaccine
• Concomitant antiviral therapy

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• MacIntyre CR, Egerton T, McCaughey M, Parrino J, Campbell BV, Su SC, Pagnoni MF, Stek JE, Xu J, Annunziato PW, Chan IS, Silber JL. Concomitant administration of zoster and pneumococcal vaccines in adults >/=60 years old. Hum Vaccin. 2010 Nov;6(11):894-902. doi: 10.4161/hv.6.11.12852. Epub 2010 Nov 1.

  PMID: 20980796 RESULT

MeSH Terms

Conditions

Herpes Zoster; Pneumococcal Infections

Interventions

Herpes Zoster Vaccine; Pneumococcal Vaccines

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Chickenpox Vaccine; Herpesvirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Streptococcal Vaccines; Bacterial Vaccines

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2007
• First Posted: September 26, 2007
• Study Start: June 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: April 12, 2017
• Results First Posted: May 13, 2009

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share