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A Study to Evaluate the Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-005)

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: NCT02531373
Recruitment Status : Completed
First Posted : August 24, 2015
Results First Posted : April 17, 2018
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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Brief Summary:
This study is designed to assess the effect of different dose levels of pneumococcal polysaccharide and adjuvant on the safety and immunogenicity of V114 in healthy adults and infants.

Condition or disease Intervention/treatment Phase
Pneumococcal Infections Biological: V114 Medium Dose Biological: V114 High Dose Biological: V114 Medium Dose with Alternative Carrier Protein Biological: V114 High Dose with Alternative Carrier Protein Biological: Prevnar 13™ Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 338 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Phase I-II, Randomized, Double-Blind, Study to Evaluate the Safety, Tolerability, and Immunogenicity of Different Formulations of V114 in Healthy Adults and Infants
Actual Study Start Date : September 15, 2015
Actual Primary Completion Date : April 14, 2017
Actual Study Completion Date : April 14, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Adult: V114 Medium Dose
Adult participants will receive a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1.
 Biological: V114 Medium Dose
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose
Experimental: Adult: V114 High Dose
Adult participants will receive a single 0.5 mL intramuscular injection of high-dose V114 on Day 1.
 Biological: V114 High Dose
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (4 mcg each), serotype 6B (8 mcg), and Merck Aluminum Phosphate Adjuvant (250 mcg) in each 0.5 mL dose
Experimental: Adult: V114 Medium Dose with Alternative Carrier Protein
Adult participants will receive a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein on Day 1.
 Biological: V114 Medium Dose with Alternative Carrier Protein
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg), and Merck Aluminum Phosphate Adjuvant (125 mcg) with alternative carrier protein in each 0.5 mL dose
Experimental: Adult: V114 High Dose with Alternative Carrier Protein
Adult participants will receive a single 0.5 mL intramuscular injection of high-dose V114 with alternative carrier protein on Day 1.
 Biological: V114 High Dose with Alternative Carrier Protein
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (4 mcg each), serotype 6B (8 mcg), and Merck Aluminum Phosphate Adjuvant (250 mcg) with alternative carrier protein in each 0.5 mL dose
Experimental: Infant: V114 Medium Dose
Infant participants will receive a 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12 to 15 months of age.
 Biological: V114 Medium Dose
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose
Experimental: Infant: V114 High Dose
Infant participants will receive a 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12 to 15 months of age.
 Biological: V114 High Dose
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (4 mcg each), serotype 6B (8 mcg), and Merck Aluminum Phosphate Adjuvant (250 mcg) in each 0.5 mL dose
Experimental: Infant: V114 Medium Dose with Alternative Carrier Protein
Infant participants will receive a 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein at 2, 4, 6, and 12 to 15 months of age.
 Biological: V114 Medium Dose with Alternative Carrier Protein
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg), and Merck Aluminum Phosphate Adjuvant (125 mcg) with alternative carrier protein in each 0.5 mL dose
Experimental: Infant: V114 High Dose with Alternative Carrier Protein
Infant participants will receive a 0.5 mL intramuscular injection of high-dose V114 with alternative carrier protein at 2, 4, 6, and 12 to 15 months of age.
 Biological: V114 High Dose with Alternative Carrier Protein
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (4 mcg each), serotype 6B (8 mcg), and Merck Aluminum Phosphate Adjuvant (250 mcg) with alternative carrier protein in each 0.5 mL dose
Active Comparator: Infant: Prevnar 13™
Infant participants will receive a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12 to 15 months of age.
 Biological: Prevnar 13™
13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose


Outcome Measures
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Primary Outcome Measures :
  1. Adults: Percentage of Participants With an Adverse Event [ Time Frame: Up to 6 weeks after vaccination ]
    An adverse event (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. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.

  2. Infants: Percentage of Participants With an Adverse Event [ Time Frame: Up to 1 month after Vaccination 4 (Month 11-15) ]
    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. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.

  3. Infants: Percentage of Participants With Study Vaccination Withdrawn Due to an Adverse Event [ Time Frame: Up to time of Vaccination 4 (Month 10-13) ]
    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. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.

  4. Infants: Percentage of Participants With a Solicited Injection-site Adverse Event [ Time Frame: Up to 14 days after any vaccination ]
    Solicited injection-site AEs were injection-site erythema, injection-site induration, injection-site pain, and injection-site swelling.

  5. Infants: Percentage of Participants With a Solicited Systemic Adverse Event [ Time Frame: Up to 14 days after any vaccination ]
    Solicited systemic AEs were irritability, decreased appetite, somnolence, and urticaria.

  6. Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies [ Time Frame: 1 month after Vaccination 3 (Month 5) ]
    Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.


Secondary Outcome Measures :
  1. Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies [ Time Frame: 1 month after vaccination ]
    Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.

  2. Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies [ Time Frame: Baseline and 1 month after vaccination ]
    Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay. GMFR is defined as the geometric mean of the ratio of concentration at 1 month after vaccination divided by concentration at baseline.

  3. Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 [ Time Frame: 1 month after Vaccination 3 (Month 5) ]
    Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.

  4. Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 [ Time Frame: Before Vaccination 4 (Month 10-13) ]
    Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.

  5. Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 [ Time Frame: 1 month after Vaccination 4 (Month 11-15) ]
    Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.

  6. Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies [ Time Frame: Before Vaccination 4 (Month 10-13) ]
    Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.

  7. Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies [ Time Frame: 1 month after Vaccination 4 (Month 11-15) ]
    Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 49 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Adult Cohort: 18 to 49 years and in good health

  • Highly unlikely to conceive from vaccination through 6 weeks after administration of the study vaccine.

Infant Cohort: approximately 2 months (42 to 90 days) and in good health.

Exclusion Criteria:

Adult cohort: Prior administration of any pneumococcal vaccine

  • History of invasive pneumococcal disease
  • Known hypersensitivity to any vaccine component
  • Known or suspected impairment of immune function
  • Coagulation disorder contraindicating intramuscular vaccination
  • Received a blood transfusion or blood products within 6 months
  • Participated in another clinical study of an investigational product within 2 months
  • Breast feeding. Infant cohort: Prior administration of any pneumococcal vaccine
  • Known hypersensitivity to any vaccine component
  • Known or suspected impairment of immune function
  • History of congenital or acquired immunodeficiency
  • Has or mother has documented Human Immunodeficiency virus (HIV) infection
  • Has or mother has documented hepatitis B surface antigen positive result
  • Functional or anatomic asplenia
  • History of failure to thrive
  • Coagulation disorder contraindicating intramuscular vaccination
  • History of autoimmune disease or autoimmune disorder
  • Known neurologic or cognitive behavioral disorder
  • Received systemic corticosteroids within 14 days
  • Received other licensed non-live vaccine within 14 days
  • Received other licensed live virus vaccine within 30 days
  • Received a blood transfusion or blood products
  • Participated in another clinical study of an investigational product
  • History of invasive pneumococcal disease
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): NCT02531373


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.
  Study Documents (Full-Text)

Documents provided by Merck Sharp & Dohme Corp.:
Study Protocol and Statistical Analysis Plan  [PDF] October 29, 2015

More Information
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Publications of Results:

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02531373    
Other Study ID Numbers: V114-005
First Posted: August 24, 2015    Key Record Dates
Results First Posted: April 17, 2018
Last Update Posted: April 2, 2019
Last Verified: March 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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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