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

Phase 3

Completed

Conditions: Pneumococcal Infections

Registration Number: NCT03692871

Lead Sponsor: 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™.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 2409

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With a Solicited Injection-site Adverse Event	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.
Percentage of Participants With a Vaccine-related Serious Adverse Event	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.
Percentage of Participants With a Solicited Systemic Adverse Event	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).

Secondary Outcome Measures

Name	Time	Method
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only)	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.
GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only)	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.
GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only)	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.
Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only)	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.

Trial Locations

Locations (76): Premier Health Research Center, LLC ( Site 0005)
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Downey, California, United States
Beach Pediatrics ( Site 0040)
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Huntington Beach, California, United States
Khruz Biotechnology Research Institute ( Site 0006)
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San Diego, California, United States
Kaiser Permanente - San Jose ( Site 0036)
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San Jose, California, United States
Kaiser Permanente - Santa Clara ( Site 0027)
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Santa Clara, California, United States
Children's Research, LLC ( Site 0025)
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Lake Mary, Florida, United States
Advanced Research For Health Improvement LLC ( Site 0030)
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Naples, Florida, United States
Pediatric Partners, P.A. ( Site 0010)
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Overland Park, Kansas, United States
Novak Center for Childrens Health ( Site 0033)
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Louisville, Kentucky, United States
Medpharmics, LLC ( Site 0037)
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Metairie, Louisiana, United States
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Premier Health Research Center, LLC ( Site 0005)
🇺🇸Downey, California, United States