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A Study of Pneumococcal Conjugate Vaccine (V114) Compared to a Marketed Vaccine (V114-003)

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: NCT01215188
Recruitment Status : Completed
First Posted : October 6, 2010
Results First Posted : April 30, 2019
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE October 4, 2010
First Posted Date  ICMJE October 6, 2010
Results First Submitted Date  ICMJE April 8, 2019
Results First Posted Date  ICMJE April 30, 2019
Last Update Posted Date April 30, 2019
Actual Study Start Date  ICMJE October 14, 2010
Actual Primary Completion Date July 31, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2019)
  • Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 [ Time Frame: One month postvaccination 3 ]
    Percentage of participants meeting the serotype-specific IgG reference level (an antibody concentration measured by the pneumococcal polysaccharide electrochemiluminescence [Pn ECL] assay corresponding to the World Health Organization enzyme-linked immunosorbent assay [WHO ELISA] ≥ 0.35 μg/mL) (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.
  • IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 [ Time Frame: One month postvaccination 3 ]
    The IgG GMCs were evaluated as measured in the Pn ECL assay, for recipients of adjuvanted V114, non-adjuvanted V114, and Prevnar 13® (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.
  • IgG GMCs for Postvaccination 4 [ Time Frame: One month postvaccination 4 ]
    The IgG GMCs were evaluated as measured in the Pn ECL assay, for recipients of adjuvanted V114, non-adjuvanted V114, and Prevnar 13® (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.
  • Number of Participants With an Adverse Event (AE) [ Time Frame: Up to Day 14 postvaccination ]
    An 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.
  • Number of Participants With an Injection-site AE [ Time Frame: Up to Day 14 postvaccination ]
    Injection-site AEs reported by > 0% of participants in one or more vaccination groups were assessed.
  • Number of Participants With a Systemic AE [ Time Frame: Up to Day 14 postvaccination ]
    Systemic AEs reported by > 0% of participants in one or more vaccination groups were assessed.
  • Number of Participants With a Serious Adverse Event (SAE) [ Time Frame: Up to one month after last dose of study vaccine ]
    An 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.
  • Number of Participants Who Discontinued the Study Due to an AE [ Time Frame: Up to Day 14 postvaccination ]
    An 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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 5, 2010)
Determine the proportion of participants receiving V114 and Prevnar 13™ who meet the WHO-defined IgG (immunoglobulin G) antibody level post-dose 3 for each of the 7 serotypes in common with 7-valent Prevnar™ [ Time Frame: 30 days postdose (dose 3) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2019)
  • Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 [ Time Frame: One month postvaccination 3 ]
    The antibody responses as measured by MOPA4 (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. Functional antibody activity was assessed only in a subset of the vaccinated participants, thus the study was not powered for assessing non-inferiority with respect to the OPA antibody responses.
  • Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 [ Time Frame: One month postvaccination 4 ]
    The antibody responses as measured by MOPA4 (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. Functional antibody activity was assessed only in a subset of the vaccinated participants, thus the study was not powered for assessing non-inferiority with respect to the OPA antibody responses.
  • OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 [ Time Frame: One month postvaccination 3 ]
    The antibody responses as measured by MOPA4 (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. The OPA antibody responses included the percentage of participants with OPA titer and the GMTs. Functional antibody activity was assessed only in a subset of the vaccinated participants, thus the study was not powered for assessing non-inferiority with respect to the OPA antibody responses.
  • OPA GMTs as Measured by MOPA4 for Postvaccination 4 [ Time Frame: One month postvaccination 4 ]
    The antibody responses as measured by MOPA4 (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. Functional antibody activity was assessed only in a subset of the vaccinated participants, thus the study was not powered for assessing non-inferiority with respect to the OPA antibody responses.
  • Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 [ Time Frame: One month postvaccination 4 ]
    Percentage of participants achieving World Health Organization (WHO) predefined antibody threshold as measured by the pneumococcal polysaccharide electrochemiluminescence (Pn ECL) assay corresponding to the WHO enzyme-linked immunosorbent assay (ELISA) value of ≥ 0.35μg/mL (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.
  • Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 [ Time Frame: One month postvaccination 4 ]
    Percentage of participants achieving WHO predefined antibody threshold as measured by the Pn ECL assay corresponding to the WHO enzyme-linked immunosorbent assay (ELISA) value of ≥ 1.0 μg/mL (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2010)
  • Determine the proportion of participants receiving V114 and Prevnar 13™ who meet the WHO-defined IgG antibody level post-dose 3 for each of the 6 serotypes in common with Prevnar 13™ [ Time Frame: 30 days postdose (dose 3) ]
  • Determine the proportion of participants receiving V114 and Prevnar 13™ who meet the WHO-defined IgG antibody levels post-dose 3 for 2 serotypes not in common with Prevnar 13™ [ Time Frame: 30 days postdose (dose 3) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Pneumococcal Conjugate Vaccine (V114) Compared to a Marketed Vaccine (V114-003)
Official Title  ICMJE A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of Pneumococcal Conjugate Vaccine (V114) Compared to Prevnar 13™ in Healthy Infants
Brief Summary This study will evaluate whether the aluminum-adjuvanted or the non-adjuvanted formulation of the candidate pneumococcal vaccine (V114) is non-inferior to Prevnar 13® based on immune responses to the 13 serotypes in common Prevnar 13®
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Pneumococcal Infections
Intervention  ICMJE
  • Biological: V114 Aluminum-adjuvanted
    15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2.2 mcg each), serotype 6B (4.4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.
  • Biological: V114 Non-adjuvanted
    15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose.
  • 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 each), serotype 6B (4.4 mcg each) and aluminum phosphate adjuvant (125 mcg) in each 0.5. mL dose.
Study Arms  ICMJE
  • Experimental: V114 Aluminum-adjuvanted
    Four intramuscular (IM) doses at 0.5 mL of aluminum-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.
    Intervention: Biological: V114 Aluminum-adjuvanted
  • Experimental: V114 Non-adjuvanted
    Four IM doses at 0.5 mL of non-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.
    Intervention: Biological: V114 Non-adjuvanted
  • Active Comparator: Prevnar 13®
    Four IM doses at 0.5 mL of Prevnar 13® at 2, 4, 6, and 12 to 15 months of age.
    Intervention: Biological: Prevnar 13®
Publications * Greenberg D, Hoover PA, Vesikari T, Peltier C, Hurley DC, McFetridge RD, Dallas M, Hartzel J, Marchese RD, Coller BG, Stek JE, Abeygunawardana C, Winters MA, MacNair JE, Pujar NS, Musey L. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine (PCV15) in healthy infants. Vaccine. 2018 Oct 29;36(45):6883-6891. doi: 10.1016/j.vaccine.2018.02.113. Epub 2018 Sep 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 14, 2012)
1152
Original Estimated Enrollment  ICMJE
 (submitted: October 5, 2010)
1110
Actual Study Completion Date  ICMJE July 31, 2012
Actual Primary Completion Date July 31, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Healthy infants ≥ 42 days to ≤ 89 days.
  • Participant's parent/legal guardian understands the study procedures, alternate treatments available and risks involved with the study, and voluntarily agrees to allow the child to participate by giving written informed consent.
  • Afebrile, with a rectal temperature <38.1°C (<100.5°F) or axillary temperature <37.8°C (<100.0°F) on day of vaccination.
  • Participant's parent/legal guardian is able to read, understand, and complete study questionnaires (i.e., the Vaccination Report Card).
  • Participant is able to attend all scheduled visits and to comply with the study procedures.
  • Participant's parent/legal guardian has access to a telephone.

Exclusion Criteria:

  • Prior administration of any pneumococcal vaccine.
  • Known hypersensitivity to any component of the pneumococcal conjugate vaccine.
  • Known or suspected impairment of immunological function.
  • Participant has a history of congenital or acquired immunodeficiency (e.g., splenomegaly).
  • Participant or his/her mother has documented human immunodeficiency virus (HIV) infection.
  • Functional or anatomic asplenia.
  • History of autoimmune disease including multiple sclerosis (MS), systemic lupus, polymyositis, inclusion body myositis, dermatomyositis, Hashimoto's thyroiditis, Sjogren's syndrome, rheumatoid arthritis, other autoimmune disorders.
  • Known neurologic or cognitive behavioral disorders including multiple sclerosis (MS), MS-like disease, encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive developmental disorder, and related disorders.
  • Use of any immunosuppressive therapy (Note: topical and inhaled/nebulized steroids are permitted). Participants on intramuscular, oral, or intravenous corticosteroid treatment should be excluded if they are receiving or expected to receive in the period from 30 days prior to Visit 1 through Visit 6 (30 days post-dose 4) more than 2 mg/kg per day of prednisone (or its equivalent), or more than 20 mg/d if they weigh more than 10 kg and are not otherwise immunocompromised. Excluded immunosuppressive therapies also include chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation, or autoimmune disease.
  • Participant has received other licensed non-live vaccines within the 14 days before receipt of study vaccine.
  • Participant has received a licensed live virus vaccine within the 30 days prior of receipt of study vaccine.
  • Prior receipt of a blood transfusion or blood products, including immunoglobulins.
  • Investigational drugs or vaccines received within the 2 months before receipt of study vaccine.
  • Participation in another clinical study within 42 days before the beginning or anytime during the duration of the current clinical study.
  • History of invasive pneumococcal disease (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease.
  • A recent febrile illness (rectal temperature ≥38.1°C [≥100.5°F]) occurring within 72 hours before receipt of study vaccine.
  • History of failure to thrive.
  • Participant has a coagulation disorder contraindicating IM vaccination.
  • Participant and his/her mother have documented hepatitis B surface antigen-positive.
  • Any infant who cannot be adequately followed for safety according to the protocol plan.
  • Participant's parent/legal guardian is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study.
  • Any other reason that in the opinion of the investigator may interfere with the evaluation required by the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Weeks to 12 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Canada,   Finland,   Puerto Rico,   Spain,   United States
 
Administrative Information
NCT Number  ICMJE NCT01215188
Other Study ID Numbers  ICMJE V114-003
V114-003 ( Other Identifier: Merck Protocol Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP