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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)

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ClinicalTrials.gov Identifier: NCT01513551
Recruitment Status : Completed
First Posted : January 20, 2012
Results First Posted : December 13, 2018
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.


Condition or disease Intervention/treatment Phase
Pneumococcal Infections Biological: Pneumococcal Conjugate Vaccine (V114) Biological: PNEUMOVAX® 23 Biological: PREVNAR 13® Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 692 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : March 13, 2012
Actual Primary Completion Date : February 15, 2013
Actual Study Completion Date : February 15, 2013


Arm Intervention/treatment
Experimental: V114
Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.
Biological: Pneumococcal Conjugate Vaccine (V114)
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.

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

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




Primary Outcome Measures :
  1. Percentage of Participants With an Adverse Event [ Time Frame: All AEs: up to 14 days after vaccination; Serious Adverse Events (SAEs): up to 6 months after vaccination ]
    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.

  2. Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups [ Time Frame: Up to Day 14 postvaccination ]
    Injection-site AEs reported by >=2% of participants in one or more vaccination groups were assessed.

  3. Percentage of Participants With a Systemic Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups [ Time Frame: Up to Day 14 postvaccination ]
    Systemic AEs reported by >=2% of participants in one or more vaccination groups were assessed.

  4. Percentage of Participants With a Serious Adverse Event [ Time Frame: Up to 6 months postvaccination ]
    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.

  5. Percentage of Participants With a Vaccine-related Serious Adverse Event [ Time Frame: Up to 6 months postvaccination ]
    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.

  6. Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies [ Time Frame: One month postvaccination ]
    Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence (ECL) assay.


Secondary Outcome Measures :
  1. Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies [ Time Frame: One month postvaccination ]
    OPA for the serotypes contained in V114 was determined using a Multiplex Opsonophagocytic Assay (MOPA-4)



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01513551


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01513551     History of Changes
Other Study ID Numbers: V114-002
2011-004542-18 ( Other Identifier: EudraCT Number )
V114-002 ( Other Identifier: Merck Protocol Number )
First Posted: January 20, 2012    Key Record Dates
Results First Posted: December 13, 2018
Last Update Posted: December 13, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Keywords provided by Merck Sharp & Dohme Corp.:
Pneumococcal vaccines
Additional relevant MeSH terms:
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Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs