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A Study to Compare the Safety and Immunogenicity of Pneumococcal Conjugate Vaccines in Healthy Volunteers (V114-002)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pneumococcal Infections

Intervention: Pneumococcal Conjugate Vaccine (V114) (Biological); Pneumococcal Polysaccharide Vaccine (Biological); Pneumococcal 13-Valent Conjugate Vaccine (Biological)

Phase: Phase 2

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Summary

The purpose of the study is to see if an investigational vaccine for Streptococcus pneumonia disease (V114) has comparable safety, tolerability, and antibody response to Pneumococcal Polysaccharide Vaccine (Pneumovax 23) and 13-valent Pneumococcal Conjugate Vaccine (Prevnar 13) when administered to healthy adults 50 years of age or older.

Clinical Details

Official title: A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of a Pneumococcal Conjugate Vaccine (V114) Compared to Pneumococcal Polysaccharide Vaccine (PNEUMOVAX 23) and Prevnar 13 (Pneumococcal 13-Valent Conjugate Vaccine [Diphtheria CRM197 Protein]) in Healthy Adults 50 Years of Age or Older

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Serotype-specific IgG geometric mean concentration (GMC) for each of the serotypes in common between V114 and pneumococcal polysaccharide vaccine

Secondary outcome: Serotype-specific geometric mean titer (GMT) by opsonophagocytic assay for each of the serotypes in common between V114 and pneumococcal polysaccharide vaccine

Eligibility

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Without fever for 72 hours prior to vaccination

Exclusion Criteria:

- Prior receipt of any pneumococcal polysaccharide vaccine or any pneumococcal

conjugate vaccine

- Known or suspected to be immunocompromised

- Functional or anatomic asplenia

- History of autoimmune disease

- Evidence of dementia or cognitive impairment

- Use of any immunosuppressive therapy

- Received a licensed non-live vaccine administered within the 14 days prior to receipt

of study vaccine or scheduled to receive any other licensed vaccine within 30 days following receipt of study vaccine

- Received a licensed live virus vaccine within 30 days prior of receipt of study

vaccine or is scheduled to receive any other licensed vaccine within 30 days of receipt of study vaccine

- Received any vaccine containing diphtheria toxoid within 6 months prior to receipt of

study vaccine

- Received a blood transfusion or blood products within the 6 months before receipt of

study vaccine or scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine

- History of invasive pneumococcal disease or known history of other

culture-positive pneumococcal disease

- Received antibiotic therapy for any acute illness within 72 hours

before receipt of study vaccine

Locations and Contacts

Additional Information

Starting date: March 2012
Last updated: February 26, 2015

Page last updated: August 23, 2015

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