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Trial record 2 of 7 for:    v114 | Phase 2
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Safety, Tolerability, and Immunogenicity of Two Formulations of V114 in Healthy Adults 50 Years of Age or Older (V114-006)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02547649
Recruitment Status : Completed
First Posted : September 11, 2015
Results First Posted : April 2, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Description
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Brief Summary:

The purpose of this study is to assess the safety, tolerability, and immunogenicity of a single dose of different formulations of V114 (V114-A and V114-B) and Prevnar 13® (pneumococcal 13-valent conjugate vaccine) in adult participants

≥50 years of age in good health.


Condition or disease Intervention/treatment Phase
Pneumococcal Infections Biological: V114-A Biological: V114-B Biological: Prevnar 13® Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 690 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in Healthy Pneumococcal Vaccine-Naïve Adults 50 Years of Age or Older
Actual Study Start Date : October 8, 2015
Actual Primary Completion Date : January 20, 2016
Actual Study Completion Date : January 20, 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: V114 Formulation A
Participants receive a single 0.5 mL intramuscular injection of V114 Formulation A on Day 1
 Biological: V114-A
Formulation A of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-A uses a unique excipient to improve stability of the vaccine against physical stress).
Experimental: V114 Formulation B
Participants receive a single 0.5 mL intramuscular injection of V114 Formulation B on Day 1
 Biological: V114-B
Formulation B of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-B uses a unique excipient to improve stability of the vaccine against physical stress).
Active Comparator: Prevnar 13®
Participants receive a single 0.5 mL intramuscular injection of Prevnar 13® on Day 1
 Biological: Prevnar 13®
Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each), and 6B (4.4 mcg) in each 0.5 mL dose.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With an Adverse Event (AE) [ Time Frame: Up to 14 days after vaccination ]
    The percentage of participants experiencing ≥1 AE(s) in each arm was determined. An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

  2. Percentage of Participants With a Solicited Injection-site Adverse Event (AE) [ Time Frame: Up to 14 days after vaccination ]
    The percentage of participants experiencing ≥1 solicited injection-site AE(s) in each arm was determined.

  3. Percentage of Participants With a Solicited Systemic Adverse Event (AE) [ Time Frame: Up to 14 days after vaccination ]
    The percentage of participants experiencing ≥1 solicited systemic AE(s) in each arm was determined.

  4. Percentage of Participants With a Serious Adverse Event (SAE) [ Time Frame: Up to 30 days after vaccination ]
    The percentage of participants experiencing ≥1 SAE(s) in each arm was determined.

  5. Percentage of Participants With Vaccine-Related Serious Adverse Event (SAE) [ Time Frame: Up to 30 days after vaccination ]
    The percentage of participants experiencing ≥1 vaccine-related SAEs(s) in each arm was determined.

  6. Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA) at One Month Post-Vaccination [ Time Frame: Day 30 (one month after vaccination) ]
    The OPA GMTs of each common serotype (CS) and V114-specific serotype (VS) were determined in each arm. Titer levels were determined with the multiplexed opsonophagocytic assay (MOPA).


Secondary Outcome Measures :
  1. Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) at One Month Post-Vaccination [ Time Frame: Day 30 (one month after vaccination) ]
    The IgG GMCs of each common pneumococcal serotype (CS) and V114-specific pneumococcal serotype (VS) were determined for each arm. Concentrations were determined with pneumococcal electrochemiluminescence (PnECL).

  2. Percentage of Participants With a ≥4-fold Rise From Baseline in Serotype-specific Opsonophagocytic Killing Activity (OPA) Geometric Mean Titers (GMTs) [ Time Frame: Baseline and Day 30 (one month after vaccination) ]
    The percentage of participants with ≥4-fold rise from baseline in OPA GMTs of each common serotype (CS) and V114-specific serotype (VS) were compared in the V114 and Prevnar® 13 arms. Estimated GMT, GMT ratio, 95% CI, and p-values were obtained from a constrained longitudinal data analysis (cLDA) model.

  3. Percentage of Participants With a ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) Antibodies [ Time Frame: Baseline and Day 30 (one month after vaccination) ]
    The percentage of participants with ≥4-fold rise from baseline in IgG GMCs of each common serotype (CS) and V114-specific serotype (VS) were compared in the V114 and Prevnar® 13 arms. Estimated GMT, GMT ratio, 95% CI, and p-values were obtained from a constrained longitudinal data analysis (cLDA) model.


Eligibility Criteria
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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:

  • Good health; any underlying chronic illness must be documented to be in stable condition
  • Highly unlikely to conceive through 6 weeks after administration of the study vaccine

Exclusion Criteria:

  • Prior administration of any pneumococcal vaccine
  • History of invasive pneumococcal disease (IPD) [positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture-positive pneumococcal disease
  • Known hypersensitivity to any vaccine component
  • Known or suspected impairment of immune function
  • Received systemic corticosteroids for >=14 consecutive days and has not completed treatment <=30 days prior to study entry, or received systemic corticosteroids exceeding physiologic replacement doses within 14 days prior to study vaccination
  • Coagulation disorder contraindicating intramuscular vaccination
  • Receives immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation, or autoimmune disease
  • Received a blood transfusion or blood products, including immunoglobulins within the 6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine. Autologous blood transfusions are not considered an exclusion criterion.
  • Participated in another clinical study of an investigational product within 2 months before the beginning of or any time during the duration of the current clinical study
  • Breast feeding
  • User of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence
Contacts and Locations
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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): NCT02547649


Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
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Study Director: Medical Director Merck Sharp & Dohme LLC
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT02547649    
Other Study ID Numbers: V114-006
V114-006 ( Other Identifier: Merck Protocol Number )
First Posted: September 11, 2015    Key Record Dates
Results First Posted: April 2, 2019
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Additional relevant MeSH terms:
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Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
 Infections
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs