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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03893448
Recruitment Status : Active, not recruiting
First Posted : March 28, 2019
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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 non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on the response rate of the 2 unique V114 serotypes compared with the lowest response rate of any of the shared serotypes in Prevnar 13™, excluding serotype 3, at 30 days following Dose 3; 3) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes based on anti-pneumococcal polysaccharide (PnPs) serotype-specific immunoglobulin g (IgG) geometric mean concentrations (GMCs) at 30 days following Dose 3; 4) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on the anti-PnPs serotype-specific IgG GMCs of the 2 unique V114 serotypes compared with the lowest IgG GMC of any of the shared serotypes in Prevnar 13™, excluding serotype 3, 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 non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on anti-PnPs serotype-specific IgG GMCs of the 2 unique V114 serotypes compared with the lowest IgG GMC of any of the shared serotypes in Prevnar 13, excluding serotype 3, at 30 days following Dose 4.

Condition or disease Intervention/treatment Phase
Pneumococcal Infections Pneumococcal Vaccines Biological: V114 Biological: Prevnar 13™ Biological: RotaTeq™ Biological: Pentacel™ Biological: RECOMBIVAX HB™ Biological: VAQTA™ Biological: MMR II™ Biological: VARIVAX™ Biological: HIBERIX™ Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1720 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: 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)
Actual Study Start Date : June 19, 2019
Estimated Primary Completion Date : May 21, 2021
Estimated Study Completion Date : May 21, 2021

Arm Intervention/treatment
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.
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: 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: MMR II™
One MMR II™ 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.

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.
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: MMR II™
One MMR II™ 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.




Primary Outcome Measures :
  1. 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.

  2. Percentage of Participants with Solicited Systemic 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 systemic AEs will consist of irritability, drowsiness, appetite lost, and hives or welts.

  3. Percentage of Participants with Vaccine-Related Serious Adverse Events (SAEs) [ Time Frame: From Day 1 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.

  4. Percentage of Participants with Anti-Pneumococcal Polysaccharide (anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) ≥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 GMC ≥0.35 µg/mL will be reported for each serotype.

  5. Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3 [ Time Frame: One month after Vaccination 3 (Month 7) ]
    Antibody levels will be measured with pneumococcal electrochemiluminescence (PnECL).

  6. Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) 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).


Secondary Outcome Measures :
  1. Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (anti-Diptheria Toxoid, Tetanus Toxoid, and Pertuss Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3 [ Time Frame: One month after Vaccination 3 (Month 7) ]
    Antibody responses to diphtheria toxoid, tetanus toxoid, and pertussis antigens will be measured using Luminex Assay. 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.

  2. Pertussis Antigen Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3 [ Time Frame: One month after Vaccination 3 (Month 7) ]
    Pertussis antibody GMCs will be determined with using Luminex Assay.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Anti-Pneumococcal Polysaccharide (anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 3 for 2 Unique V114 Seroptypes [ Time Frame: One month after Vaccination 3 (Month 7) ]
    Serotype-specific anti-PnP IgG GMCs for the 2 unique V114 serotypes will be measured with pneumococcal electrochemiluminescence (PnECL). The GMCs for each serotype will be summarized.

  8. Anti-Pneumococcal Polysaccharide (anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Response Rates One Month After Vaccination 3 for 2 Unique V114 Seroptypes [ Time Frame: One month after Vaccination 3 (Month 7) ]
    Serotype-specific anti-PnP IgG response rates or the 2 unique V114 serotypes will be measured with pneumococcal electrochemiluminescence (PnECL).

  9. Anti-Pneumococcal Polysaccharide (anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMC) One Month After Vaccination 4 for 2 Unique V114 Seroptypes [ Time Frame: One month after Vaccination 4 (Month 13 to Month 16) ]
    Serotype-specific anti-PnP GMCs will be measured with pneumococcal electrochemiluminescence (PnECL).

  10. Anti-Pneumococcal Polysaccharide (anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3 [ Time Frame: One month after Vaccination 3 (Month 7) ]
    Serotype-specific anti-PnP OPA GMTs will be measured with fourfold multiplex opsonophagocytic assay (MOPA-4). The GMTs for each serotype will be summarized.

  11. 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 multiplex opsonophagocytic assay (MOPA-4). The percentage of participants meeting assay-derived threshold values will be reported for each serotype.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   42 Days to 90 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT03893448


Locations
Show Show 81 study locations
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03893448    
Other Study ID Numbers: V114-029
V114-029 ( Other Identifier: Merck )
2018-004109-21 ( EudraCT Number )
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
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
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs