A Phase III Clinical Trial to Study the Safety and Immunogenicity of Pneumovax™ 23 (V110) in Participants From the Russian Population (V110-018)

NCT01734239 | Completed Phase 3 Results

• 1 other identifier: V110-018
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine if Pneumovax™ 23 (V110) is safe and immunogenic in participants from the Russian population who are 50 years of age and older or 2 to 49 years of age and at increased risk for pneumococcal disease

Conditions

Pneumococcal Disease

Outcome Measures

Primary Outcomes (5)

• Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine

  Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays

  Prevaccination and Day 28 after vaccination

• Percentage of Participants With >=2-fold Increase From Prevaccination to Postvaccination in Antibodies to Pneumococcal Serotypes Contained in the Vaccine

  Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. A \>=2-fold increase in serum antibody is a marker for serologic response to pneumococcal vaccination in adults.

  Day 28 postvaccination

• Number of Participants With Elevated Body Temperature (>=37.6 °C Axillary / >=38.0 °C Oral or Equivalent)

  Up to 5 days postvaccination

• Number of Participants Reporting an Injection-site or Systemic Adverse Experience That Was Reported by >=4 Participants

  An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an AE. Injection-site or systemic AEs that occurred in \>=4 participants were reported for this endpoint.

  Up to Day 14 postvaccination

• Number of Participants Reporting Serious Adverse Experiences

  A serious AE (SAE) is an AE that 1) results in death, 2) is life threatening, 3) results in a persistent or significant disability or incapacity, 4) results in or prolongs an existing inpatient hospitalization, 5) is a congenital anomaly or birth defect, 6) is a cancer, 7) is an overdose, or 8) is another important medical event which, based on appropriate medical judgment, may jeopardize the participant and may require medical or surgical intervention

  Up to Day 28 postvaccination

Study Arms (2)

Pneumovax™ 23: Participants Between 2 and 49 Years

EXPERIMENTAL

Participants received a single, 0.5-mL intramuscular injection of Pneumovax™ 23 on Day 1

Biological: Pneumovax™ 23

Pneumovax™ 23: Participants >=50 Years

EXPERIMENTAL

Participants received a single, 0.5-mL intramuscular injection of Pneumovax™ 23 on Day 1

Biological: Pneumovax™ 23

Interventions

Pneumovax™ 23 BIOLOGICAL

Vaccine contains 25 µg of each of the 23 pneumococcal polysaccharides serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F

Also known as: V110

Pneumovax™ 23: Participants >=50 Years; Pneumovax™ 23: Participants Between 2 and 49 Years

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• For participants 50 years of age or older: any underlying chronic illness must be in stable condition
• For participants 2 to 49 years of age: participant has an increased risk for pneumococcal disease as a result of one of the following: chronic cardiovascular disease, chronic pulmonary disease, diabetes mellitus, alcoholism, chronic liver disease, cerebrospinal fluid leaks, functional or anatomic asplenia, sickle cell anemia, living in a special environment or social setting such as crowded, closed communities
• Male, or female not of reproductive potential, or female of reproductive potential who agrees to remain abstinent or to use 2 acceptable methods of contraception through 6 weeks after study vaccination

You may not qualify if:

• Received prior vaccination with pneumococcal vaccine
• Has known or suspected immune dysfunction or conditions associated with immunosuppression, or is receiving immunosuppressive chemotherapy, including long-term systemic corticosteroids
• Has history of autoimmune disease
• Received a licensed live virus vaccine within 3 months before or is scheduled within 3 months after study vaccination
• Received a licensed inactivated vaccine within 28 days before or is scheduled within 28 days after study vaccination
• Received an investigational drug or other investigational vaccine within 2 months before or is scheduled within 28 days after study vaccination (3 months if a live virus vaccine)
• Received any blood product or immunoglobulin preparation within 6 months before or 28 days after study vaccination
• Hospitalized for acute illness within 3 months before study vaccination
• Is a pregnant woman or nursing mother
• History of invasive pneumococcal disease or of other culture-positive pneumococcal disease
• History of fever illness within 3 days before study vaccination
• Received antibiotic therapy for any acute illness within 7 days before study vaccination
• Hypersensitivity to any components of the vaccine, including phenol

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Ciprero K, Zykov KA, Briko NI, Shekar T, Sterling TM, Bitieva E, Stek JE, Musey L. Safety and immunogenicity of a single dose 23-valent pneumococcal polysaccharide vaccine in Russian subjects. Hum Vaccin Immunother. 2016 Aug 2;12(8):2142-2147. doi: 10.1080/21645515.2016.1165373. Epub 2016 May 5.

  PMID: 27149114 RESULT

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

2,4,5,4'-tetrachlorodiphenylsulfoxide

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

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 Director

  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: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2012
• First Posted: November 27, 2012
• Study Start: June 3, 2013
• Primary Completion: October 22, 2013
• Study Completion: October 22, 2013
• Last Updated: October 30, 2018
• Results First Posted: September 5, 2014

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share