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Trial record 2 of 15 for:    Completed Studies | Interventional Studies | Pneumococcal Infections | Poland | Child

Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-025) (PNEU-PED-EU-1)

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ClinicalTrials.gov Identifier: NCT04031846
Recruitment Status : Completed
First Posted : July 24, 2019
Last Update Posted : August 10, 2021
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This study will evaluate the safety and tolerability and immunogenicity of V114 when administered to 2-month old infants. The primary hypotheses are: 1) V114 is non-inferior to Prevenar 13™ for the 13 shared serotypes between V114 and Prevenar 13™ based on response rates at 30 days post toddler dose (PTD); 2) V114 is superior to Prevenar 13™ for the 2 serotypes unique to V114 based on the response rates at 30 days PTD; 3) V114 is non-inferior to Prevenar 13™ for the 13 shared serotypes between V114 and Prevenar 13™ based on anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobin G (IgG) geometric mean concentrations (GMCs) at 30 days PTD; and 4) V114 is superior to Prevenar 13™ for the 2 serotypes unique to V114 based on anti-PnPs serotype-specific IgG GMCs at 30 days PTD.

Condition or disease Intervention/treatment Phase
Pneumococcal Infections Drug: Rotarix™ Drug: Infanrix™ hexa Drug: V114 Drug: Prevenar 13™ Phase 3

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Study Type : Interventional
Actual Enrollment : 1188 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 V114 in Healthy Infants (PNEU-PED-EU-1)
Actual Study Start Date : September 4, 2019
Actual Primary Completion Date : August 5, 2021
Actual Study Completion Date : August 5, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: V114
Full-term infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received intramuscular injection of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age and 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age.
Drug: Rotarix™
Single 1.5 mL oral dose at 2 and 4 months of age (Study Day 1 and Month 2)

Drug: Infanrix™ hexa
Single 0.5 mL intramuscular injection at 2, 3, 4, and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13)

Drug: V114
15-valent pneumococcal conjugate vaccine (PCV) containing 13 serotypes present in Prevenar 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,
Other Name: VAXNEUVANCE™

Active Comparator: Prevenar 13™
Full-term infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received intramuscular injection of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age and 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age.
Drug: Rotarix™
Single 1.5 mL oral dose at 2 and 4 months of age (Study Day 1 and Month 2)

Drug: Infanrix™ hexa
Single 0.5 mL intramuscular injection at 2, 3, 4, and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13)

Drug: Prevenar 13™
13-valent PCV containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in each 0.5 mL intramuscular administration.




Primary Outcome Measures :
  1. Percentage of Participants That Report at Least 1 Solicited Injection-site Adverse Event (AE)s [ Time Frame: Up to 14 days post any vaccination ]
    Injection-site AEs solicited on the Vaccine Report Card were redness, swelling, hard lump, and pain/tenderness. The percentage of participants with 1 or more solicited injection-site AEs will be assessed.

  2. Percentage of Participants that Report at Least 1 Solicited Systemic AE [ Time Frame: Up to 14 days post any vaccination ]
    Systemic AEs solicited on the Vaccine Report Card were irritability, drowsiness, hive/welts, and appetite loss. The percentage of participants with 1 or more solicited systemic AEs will be assessed

  3. Percentage of Participants That Report at Least 1 Vaccine-related Serious Adverse Event (SAE) [ Time Frame: Up to 6 months post last vaccination ]
    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. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event. The percentage of participants that experienced 1 or more SAEs that was reported as at least possibly related to the study drug will be assessed.

  4. Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific IgG Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) [ Time Frame: 30 days PTD (Postdose 3 for full-term infants; Postdose 4 for preterm infants) ]
    Sera from participants will be used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using pneumococcal electrochemiluminescence (PnECL). The GMC for each serotype contained in V114 will be assessed.

  5. Percentage of Participants Who Meet Serotype-specific Immunoglobin G (IgG) Threshold Value of ≥0.35 μg/mL) for Each Serotype Contained in V114: 30 Days Post Toddler Dose (PTD) [ Time Frame: 30 days PTD (Postdose 3 for full-term infants; Postdose 4 for preterm infants) ]
    Sera from participants will be used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using pneumococcal electrochemiluminescence (PnECL). The percentage of participants that achieve the threshold value of ≥0.35 μg/mL will be assessed.


Secondary Outcome Measures :
  1. Percentage of Participants Who Meet Antigen-Specific Threshold Value for Each Antigen in Infanrix™ Hexa: 30 Days PTD [ Time Frame: 30 days PTD (Postdose 3 for full-term infants; Postdose 4 for preterm infants) ]
    Sera from participants will be used to measure vaccine-induced antibodies for the antigens contained in Infanrix. The percentage of participants that achieve the antigen-specific threshold value will be assessed.

  2. Anti-rotavirus Immunoglobulin A (IgA) Geometric Mean Titers (GMTs) of Rotarix™: 30 Days Post Primary Series (PPS) [ Time Frame: 30 days PPS (Postdose 2 for fullterm infants; Postdose 3 for preterm infants) ]
    Sera from participants will be used to measure vaccine-induced antibodies (Immunoglobin A; [IgA]) for the antigens contained in Rotarix™. The GMT for each antigen contained in Rotarix™ will be assessed.

  3. Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) for Each Serotype Contained in V114: 30 Days Post Primary Series (PPS) [ Time Frame: 30 days PPS; (Postdose 2 for full-term infants; Postdose 3 for preterm infants) ]
    Sera from participants will be used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using PnECL. The GMC for each serotype contained in V114 will be assessed.

  4. Percentage of Participants Who Meet Serotype-specific Immunoglobin G (IgG) Threshold Value of ≥0.35 μg/mL for Each Serotype Contained in V114; 30 Days PPS [ Time Frame: 30 days PPS (Postdose 2 for full-term infants; Postdose 3 for preterm infants) ]
    Sera from participants will be used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using PnECL. The percentage of participants that achieve the threshold value of ≥0.35 μg/mL will be assessed.

  5. Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs of Each Serotype Contained in V114: 30 Days PTD [ Time Frame: 30 days PTD (Postdose 3 for full-term infants; Postdose 4 for preterm infants) ]
    Sera from participants will be used to measure vaccine-induced anti-PnPs serotype-specific OPA for all the 15 serotypes contained in V114. The OPA GMT for each serotype will be assessed.

  6. Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype Contained in V114: 30 Days PTD [ Time Frame: 30 days PTD (Postdose 3 for full-term infants; Postdose 4 for preterm infants) ]
    Sera from participants will be used to measure vaccine-induced anti-PnPs serotype-specific OPA for the antigens contained in V114. The percentage of participants that achieve the GMT response threshold value will be assessed for each serotype.

  7. Percentage of Participants Who Meet Serotype-specific IgG Threshold Value IgG Threshold Value of ≥0.35 μg/mL for 2 Unique Serotypes Contained in V114 at 30 Days PTD [ Time Frame: 30 days PTD (Postdose 3 for full-term infants; Postdose 4 for preterm infants) ]
    Sera from participants will be used to measure vaccine-induced anti-PnPs serotype-specific IgG for the 2 unique serotypes using PnECL. The percentage of participants that achieve the threshold value of ≥0.35 μg/mL will be assessed.



Information from the National Library of Medicine

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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

  • Healthy
  • 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

  • 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 or suspected impairment of immunological function
  • Has a history of congenital or acquired immunodeficiency
  • Has, or his/her mother has, a documented human immunodeficiency virus (HIV) infection
  • Has, or his/her mother has, a documented hepatitis B surface antigen - positive test
  • Has known or history of functional or anatomic asplenia
  • Has failure to thrive based on the clinical judgement of the Investigator
  • Has a bleeding disorder contraindicating intramuscular vaccination
  • Has a history of autoimmune disease (including but not limited to systemic lupus erythematosus, antiphospholipid syndrome, Behcet's disease, autoimmune thyroid disease, polymyositis and dermatomyositis, scleroderma, Type 1 diabetes mellitus, or other autoimmune disorders)
  • Has a known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders
  • Has received a dose of any pneumococcal vaccine prior to study entry
  • Has received >1 dose of monovalent hepatitis B vaccine or hepatitis B-based combination vaccine prior to study entry
  • Has received a dose of any acellular pertussis- or whole cell pertussis-based combination vaccines, Haemophilus influenzae type b conjugate vaccine, poliovirus vaccine, rotavirus vaccine, or any other combination thereof, prior to study entry
  • Has received a blood transfusion or blood products, including immunoglobulins
  • Has participated in another clinical study of an investigational product before the beginning or anytime during the duration of the current clinical study. Participants enrolled in observational studies may be included; these will be reviewed on a case-by-case basis for approval by the Sponsor
  • Is or has an immediate family member (eg, parent/legal guardian or sibling) who is investigational site or Sponsor staff directly involved with this study

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): NCT04031846


Locations
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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: NCT04031846    
Other Study ID Numbers: V114-025
2018-003787-31 ( EudraCT Number )
V114-025 ( Other Identifier: Merck, Sharp & Dohme )
First Posted: July 24, 2019    Key Record Dates
Last Update Posted: August 10, 2021
Last Verified: August 2021
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: No
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