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A Study to Evaluate the Safety and Tolerability of V114 and Prevnar 13™ in Healthy Infants (V114-031/PNEU-LINK)

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: NCT03692871
Recruitment Status : Completed
First Posted : October 2, 2018
Results First Posted : May 10, 2022
Last Update Posted : May 10, 2022
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Brief Summary:
This study is designed to evaluate the safety and tolerability of V114 and Prevnar 13™ in healthy infants. This study will include both full-term infants (≥37 weeks gestational age) and premature infants (<37 weeks gestational age). Premature infants will be included in a Premature Infant Immunogenicity Substudy, which will assess immunogenicity and safety following administration of V114 or Prevnar 13™.

Condition or disease Intervention/treatment Phase
Pneumococcal Infections Biological: V114 Biological: Prevnar 13™ Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2409 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 and Tolerability of V114 in Healthy Infants (PNEU-LINK)
Actual Study Start Date : December 14, 2018
Actual Primary Completion Date : March 26, 2021
Actual Study Completion Date : March 26, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: V114
Participants will receive a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
Biological: V114
V114 pneumococcal capsular polysaccharide 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
Other Names:
  • VAXNEUVANCE™
  • Pneumococcal 15-Valent Conjugate Vaccine

Active Comparator: Prevnar 13™
Participants will receive a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
Biological: Prevnar 13™
Prevnar 13™ pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each) and 6B (4.4 mcg) in each 0.5 ml dose




Primary Outcome Measures :
  1. Percentage of Participants With a Solicited Injection-site Adverse Event [ Time Frame: Up to Day 14 after each study vaccination ]
    An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs included injection-site erythema (redness), injection-site induration (hard lump), injection-site pain (tenderness), and injection-site swelling.

  2. Percentage of Participants With a Solicited Systemic Adverse Event [ Time Frame: Up to Day 14 after each study vaccination ]
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs included decreased appetite, irritability, somnolence (drowsiness), and urticaria (hives or welts).

  3. Percentage of Participants With a Vaccine-related Serious Adverse Event [ Time Frame: Up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1) ]
    A serious adverse event (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. SAEs that were reported by the investigator to be at least possibly related to the study vaccination were summarized.


Secondary Outcome Measures :
  1. Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) [ Time Frame: 30 days after Vaccination 3 (approximately 5 months after Vaccination 1) ]
    The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy.

  2. GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) [ Time Frame: Before Vaccination 4 (10-13 months after Vaccination 1) ]
    The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy.

  3. GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) [ Time Frame: 30 days after Vaccination 4 (11-14 months after Vaccination 1) ]
    The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy.

  4. Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) [ Time Frame: 30 days after Vaccination 3 (approximately 5 months after Vaccination 1) ]
    The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. Immunoglobulin G for the 15 serotypes contained in V114 vaccine was determined using a pneumococcal electrochemiluminescence (PnECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy.



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 (based on a review of medical history and physical examination) based on the clinical judgment of the investigator
  • Male or female approximately 2 months of age, from 42 days to 90 days inclusive, at the time of obtaining the informed consent
  • Have 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
  • Known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV) or any diphtheria toxoid containing vaccine
  • Known or suspected impairment of immunological function
  • History of congenital or acquired immunodeficiency
  • Has or his/her mother has a documented human immunodeficiency virus (HIV) infection
  • Known or history of functional or anatomic asplenia
  • Failure to thrive based on the clinical judgment of the investigator
  • Known coagulation disorder contraindicating intramuscular vaccination
  • 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)
  • Known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders
  • Received a dose of any pneumococcal vaccine prior to study entry
  • Received a blood transfusion or blood products, including immunoglobulins, before receipt of first dose of study vaccine
  • 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.
  • Has any other reason that, in the opinion of the investigator, may interfere with the evaluation required by the study
  • Has an immediate family member 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): NCT03692871


Locations
Show Show 76 study locations
Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
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Study Director: Medical Director Merck Sharp & Dohme LLC
  Study Documents (Full-Text)

Documents provided by Merck Sharp & Dohme LLC:
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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT03692871    
Other Study ID Numbers: V114-031
V114-031 ( Other Identifier: Merck )
2018-003308-38 ( EudraCT Number )
First Posted: October 2, 2018    Key Record Dates
Results First Posted: May 10, 2022
Last Update Posted: May 10, 2022
Last Verified: April 2022
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