The Safety, Tolerability, and Immunogenicity Profiles of a Single Dose of V114, PNEUMOVAX® 23, or PREVNAR 13® in Adults 50 Years of Age or Older (V114-002)

NCT01513551 | Completed Phase 2 Results DMC

• 2 other identifiers: V114-0022011-004542-18
• Study Type: interventional
• Target: 692
• Locations: 0 countries
• Sites: N/A

Brief 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. The primary hypothesis is the serotype-specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) as measured by the pneumococcal electrochemiluminescence (Pn ECL) assay at one month postvaccination in subjects who receive V114 will be noninferior to those measured in subjects who receive PNEUMOVAX® 23.

Conditions

Pneumococcal Infections

Keywords

Pneumococcal vaccines

Outcome Measures

Primary Outcomes (6)

• Percentage of Participants With an Adverse Event

  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 (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse experience.

  All AEs: up to 14 days after vaccination; Serious Adverse Events (SAEs): up to 6 months after vaccination

• Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups

  Injection-site AEs reported by \>=2% of participants in one or more vaccination groups were assessed.

  Up to Day 14 postvaccination

• Percentage of Participants With a Systemic Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups

  Systemic AEs reported by \>=2% of participants in one or more vaccination groups were assessed.

  Up to Day 14 postvaccination

• Percentage of Participants With a Serious Adverse Event

  A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.

  Up to 6 months postvaccination

• Percentage of Participants With a Vaccine-related Serious Adverse Event

  A SAE is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. SAEs deemed by the investigator to be possibly, probably, or definitely related to study vaccine were reported.

  Up to 6 months postvaccination

• Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies

  Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence (ECL) assay.

  One month postvaccination

Secondary Outcomes (1)

• Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies

  One month postvaccination

Study Arms (3)

V114

EXPERIMENTAL

Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.

Biological: Pneumococcal Conjugate Vaccine (V114)

PNEUMOVAX® 23

ACTIVE COMPARATOR

Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1.

Biological: PNEUMOVAX® 23

PREVNAR 13®

ACTIVE COMPARATOR

Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1.

Biological: PREVNAR 13®

Interventions

Pneumococcal Conjugate Vaccine (V114) BIOLOGICAL

15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.

V114

PNEUMOVAX® 23 BIOLOGICAL

23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose.

PNEUMOVAX® 23

PREVNAR 13® BIOLOGICAL

13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F, serotype 6B (4.4 mcg each) and aluminum phosphate adjuvant (125 mcg) in each 0.5. mL dose.

PREVNAR 13®

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Without fever for 72 hours prior to vaccination

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Ermlich SJ, Andrews CP, Folkerth S, Rupp R, Greenberg D, McFetridge RD, Hartzel J, Marchese RD, Stek JE, Abeygunawardana C, Musey LK. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naive adults >/=50 years of age. Vaccine. 2018 Oct 29;36(45):6875-6882. doi: 10.1016/j.vaccine.2018.03.012. Epub 2018 Mar 17.

  PMID: 29559167 DERIVED

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

Pneumococcal Vaccines; 13-valent pneumococcal vaccine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

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 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2011
• First Posted: January 20, 2012
• Study Start: March 13, 2012
• Primary Completion: February 15, 2013
• Study Completion: February 15, 2013
• Last Updated: December 13, 2018
• Results First Posted: December 13, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share