Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029) (PNEU-PED)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03893448
Recruitment Status : Recruiting
First Posted : March 28, 2019
Last Update Posted : December 6, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE March 26, 2019
First Posted Date  ICMJE March 28, 2019
Last Update Posted Date December 6, 2019
Actual Study Start Date  ICMJE June 19, 2019
Estimated Primary Completion Date December 22, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2019)
  • Percentage of Participants with Solicited Injection-Site Adverse Events (AEs) [ Time Frame: Up to 14 days after each vaccination ]
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs will consist of swelling, redness, pain or tenderness, and hard lump.
  • Percentage of Participants with Solicited Systemic Adverse Events (AEs) [ Time Frame: Up to 6 months after Vaccination 4 (up to 21 months) ]
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs will consist of irritability, drowsiness, appetite lost, and hives or welts.
  • Percentage of Participants with Vaccine-Related Serious Adverse Events (SAEs) [ Time Frame: Up to 6 months after Vaccination 4 (up to 21 months) ]
    An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an other important medical event. Any SAEs that are at least possibly related to vaccination will be summarized.
  • Percentage of Participants with Anti-Pneumococcal Polysaccharide (anti-PNP) Immunoglobulin G (IgG) Antibody (Ab) Titers ≥0.35 µg/mL One Month After Vaccination 3 [ Time Frame: One month after Vaccination 3 (Month 7) ]
    Anti-PNP serotype-specific IgG responses for the 15 serotypes contained in V114 will be measured with pneumococcal electrochemiluminescence (PnECL). The percentage of participants with IgG Ab titers ≥0.35 µg/mL will be reported for each serotype.
  • Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Polysaccharide (anti-PNP) Immunoglobulin G (IgG) Antibody (Ab) Titers One Month After Vaccination 3 [ Time Frame: One month after Vaccination 3 (Month 7) ]
    Antibody levels will be measured with pneumococcal electrochemiluminescence (PnECL).
  • Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Polysaccharide (anti-PNP) Immunoglobulin G (IgG) Antibody (Ab) Titers One Month After Vaccination 4 [ Time Frame: One month after Vaccination 4 (Month 13 to Month 16) ]
    Antibody levels will be measured with pneumococcal electrochemiluminescence (PnECL).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03893448 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2019)
  • Percentage of Participants with Pentacel™-Specific Anti-Pneumococcal Polysaccharide (anti-PNP) Immunoglobulin G (IgG) Antibody (Ab) Titers Meeting Seotype-Specific Response Rate Criteria One Month After Vaccination 3 [ Time Frame: One month after Vaccination 3 (Month 7) ]
    Antibody responses to each antigen contained in Pentacel™ will be determined among participants in each arm who receive Pentacel™ as part of routine vaccination using pneumococcal electrochemiluminescence (PnECL). The percentage of participants meeting specific criteria will be summarized for each serotype. The serotype-specific response rate criteria are as follows: diphtheria toxoid: % ≥0.1 IU/mL; tetanus toxoid: % ≥0.1 IU/mL; pertussis toxin (PT): % ≥ 5 EU/mL; pertussis filamentous hemagglutinin (FHA): % ≥5 EU/mL; pertussis fimbrae types 2/3 (FIM 2/3): % ≥20 EU/mL; pertussis pertactin (PRN): % ≥5 EU/mL; poliovirus 1: % ≥1:8 dilution; poliovirus 2: % ≥1:8 dilution, poliovirus 3: % ≥1:8 dilution; and Haemophilus influenzae Type B polyribosylribitol phosphate (Hib PRP): % ≥0.15 µg/mL.
  • Hepatitis A Antibody Response Rate One Month After Vaccination 4 [ Time Frame: One month after Vaccination 4 (Month 13 to Month 16) ]
    Antibody response rates to hepatitis A will be measured with hepatitis A virus enzyme immunoassay (HAV EIA). The percentage of participants with hepatitis A antigen ≥10 mIU/mL will be determined.
  • Measles, Mumps, and Rubella Antibody Response Rate One Month After Vaccination 4 [ Time Frame: One month after Vaccination 4 (Month 13 to Month 16) ]
    Antibody responses to measles will be measured with the bulk measles immunoglobulin G (IgG) enzyme immunoassay (EIA). Antibody responses to mumps will be measured with enzyme-linked immunosorbent assay (ELISA). Antibody responses to rubella will be measured with Bulk Rubella IgG EIA. The percentage of participants with measles antigen ≥255 mIU/ML; mumps antigen ≥10 mumps Ab units/mL; and rubella antigen ≥10 IU/mL, will be determined.
  • Varicella-Zoster Virus (VZV) Antibody Response Rate One Month After Vaccination 4 [ Time Frame: One month after Vaccination 4 (Month 13 to Month 16) ]
    Antibody responses to varicella-zoster virus will be measured with glycoprotein enzyme-linked immunosorbent assay (gpELISA). The percentage of participants with VZV antigen ≥5 gpELISA units/mL will be determined.
  • Haemophilus Influenzae Type B Antibody Response Rate One Month After Vaccination 4 [ Time Frame: One month after Vaccination 4 (Month 13 to Month 16) ]
    Antibody responses to Haemophilus influenzae Type B polyribosylribitol phosphate (Hib PRP) will be measured with enzyme-linked immunosorbent assay (ELISA). The percentage of participants with anti-HiB PRP antigen ≥0.15 µg/mL will be determined.
  • Anti-Pneumococcal Polysaccharide (anti-PNP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) One Month After Vaccination 3 [ Time Frame: One month after Vaccination 3 (Month 7) ]
    Serotype-specific anti-PNP OPA GMTs will be measured with pneumococcal electrochemiluminescence (PnECL). The GMTs for each serotype will be summarized.
  • Anti-Pneumococcal Polysaccharide (anti-PNP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3 [ Time Frame: One month after Vaccination 3 (Month 7) ]
    Serotype-specific anti-PNP OPA GMTs will be measured with pneumococcal electrochemiluminescence (PnECL). The percentage of participants with OPA GMTs ≥0.35 µg/mL will be reported for each serotype.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029)
Official Title  ICMJE A Phase 3, Multicenter, Randomized, Double-blind, Active-Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 4-dose Regimen of V114 in Healthy Infants (PNEU-PED)
Brief Summary The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V114 in healthy infants. The primary hypotheses are that: 1) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114 and Prevnar 13™ based on response rates at 30 days following Dose 3; 2) V114 is superior to Prevnar 13™ for the 2 serotypes unique to V114 based on response rates at 30 days following Dose 3; 3) V114 is non-inferior to Prevnar 13™ based on anti-pneumococcal polysaccharide (PnPs) serotype-specific immunoglobulin g (IgG) geometric mean concentrations (GMCs) at 30 days following Dose 3; 4) V114 is superior to Prevnar 13™ for the 2 serotypes unique to V114 based on anti-PnPs serotype-specific IgG GMCs at 30 days following Dose 3; 5) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114 and Prevnar 13™ based on anti-PnPs serotype-specific IgG GMCs at 30 days following Dose 4; and 6) V114 is superior to Prevnar 13™ for the 2 serotypes unique to V114 based on anti-PnPs serotype-specific IgG GMCs at 30 days following Dose 4.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Pneumococcal Infections
  • Pneumococcal Vaccines
Intervention  ICMJE
  • Biological: V114
    V114 15-valent pneumococcal conjugate vaccine containing 13 serotypes present in Prevnar 13® (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) and 2 unique serotypes (22F and 33F) in each 0.5 mL intramuscular administration.
  • Biological: Prevnar 13™
    Prevnar 13™ 13-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in each 0.5 mL IM administration.
  • Biological: RotaTeq™
    A total of 3 RotaTeq™ 2 mL oral dosings at ~2, 4, and 6 months of age.
  • Biological: Pentacel™
    A total of 3 Pentacel™ 0.5 mL IM dosings at ~2, 4, and 6 months of age.
  • Biological: RECOMBIVAX HB™
    A total of 3 RECOMBIVAX HB™ 0.5 mL IM dosings at ~2, 4, and 6 months of age.
  • Biological: VAQTA™
    One VAQTA™ 0.5 mL IM dosing at 12 to 15 months of age.
  • Biological: M-M-R™
    One M-M-R™ 0.5 mL subcutaneous (SC) dosing at 12 to 15 months of age.
  • Biological: VARIVAX™
    One VARIVAX™ 0.5 mL SC dosing at 12 to 15 months of age.
  • Biological: HIBERIX™
    One HIBERIX™ 0.5 mL IM dosing at Visit 5.
Study Arms  ICMJE
  • Experimental: V114
    Participants receive 4 total 0.5 mL intramuscular (IM) vaccinations at ~2, 4, 6, and 12 to 15 months of age. Participants will receive other vaccinations (i.e., RotaTeq™, Pentacel™, RECOMBIVAX HB™, VAQTA™, M-M-R II™, VARIVAX™, and HIBERIX™) as part of their vaccination schedule.
    Interventions:
    • Biological: V114
    • Biological: RotaTeq™
    • Biological: Pentacel™
    • Biological: RECOMBIVAX HB™
    • Biological: VAQTA™
    • Biological: M-M-R™
    • Biological: VARIVAX™
    • Biological: HIBERIX™
  • Active Comparator: Prevnar 13™
    Participants receive 4 total 0.5 mL IM vaccinations at ~2, 4, 6, and 12 to 15 months of age. Participants will also receive other vaccines (i.e., RotaTeq™, Pentacel™, RECOMBIVAX HB™, VAQTA™, M-M-R II™, VARIVAX™, and HIBERIX™) as part of their vaccination schedule.
    Interventions:
    • Biological: Prevnar 13™
    • Biological: RotaTeq™
    • Biological: Pentacel™
    • Biological: RECOMBIVAX HB™
    • Biological: VAQTA™
    • Biological: M-M-R™
    • Biological: VARIVAX™
    • Biological: HIBERIX™
Publications * Not Provided

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 26, 2019)
1720
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 20, 2021
Estimated Primary Completion Date December 22, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Is healthy (based on a review of medical history and physical examination) in the clinical judgement of the investigator
  • Has a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent.

Exclusion Criteria:

  • Has a 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.
  • Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV), any component of the licensed pediatric vaccines to be administered concomitantly in the study, or any diphtheria toxoid-containing vaccine.
  • Has any contraindication to the concomitant study vaccines being administered in the study.
  • Had a recent febrile illness (rectal temperature =38.1°C [=100.5°F] or axillary temperature =37.8°C [=100.0°F]) occurring within 72 hours prior to receipt of study vaccine.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 42 Days to 90 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com
Listed Location Countries  ICMJE Puerto Rico,   Thailand,   Turkey,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03893448
Other Study ID Numbers  ICMJE V114-029
V114-029 ( Other Identifier: Merck )
2018-004109-21 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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 December 2019

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