A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Children With Sickle Cell Disease (V114-023/PNEU-SICKLE)

NCT03731182 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: V114-0232018-001152-35
• Study Type: interventional
• Target: 104
• Locations: 7 countries
• Sites: 19

Brief Summary

This study is designed to describe the safety, tolerability, and immunogenicity of V114 in children with sickle cell disease.

Conditions

Pneumococcal Infections

Outcome Measures

Primary Outcomes (4)

• Percentage of Participants With a Solicited Injection-site Adverse Event

  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.

  Up to 14 days post-vaccination

• Percentage of Participants With a Solicited Systemic Adverse Event

  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 arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain), and urticaria (hives or welts).

  Up to 14 days post-vaccination

• Percentage of Participants With a Vaccine-related Serious Adverse Event

  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.

  Up to 6 months post-vaccination

• Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30

  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.

  Day 30

Secondary Outcomes (3)

• Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30

  Day 30

• Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30

  Day 1 (Baseline) and Day 30

• GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30

  Day 1 (Baseline) and Day 30

Study Arms (2)

V114

EXPERIMENTAL

Participants will receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.

Biological: V114

Prevnar 13™

ACTIVE COMPARATOR

Participants will receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1.

Biological: Prevnar 13™

Interventions

V114 BIOLOGICAL

V114 pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose

V114

Prevnar 13™ BIOLOGICAL

Prevnar 13™ pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose

Prevnar 13™

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Documented diagnosis of sickle cell disease in their medical record
• Female participants: not pregnant or breastfeeding, and at least 1 of the following conditions apply:
• \) not a woman of childbearing potential (WOCBP) as defined in the protocol, or 2) a WOCBP who agrees to follow the contraceptive guidance in the protocol during the treatment period and for at least 6 weeks after the last dose of study vaccine
• 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/assent.

You may not qualify if:

• History of Invasive Pneumococcal Disease (positive blood culture, positive cerebrospinal fluid culture, or positive culture at another sterile site) or known history of other culture-positive pneumococcal disease within 3 years of Visit 1 (Day 1)
• Known hypersensitivity to any component of pneumococcal conjugate vaccine (PCV), or any diphtheria toxoid-containing vaccine
• Known or suspected impairment of immunological function
• History of congenital or acquired immunodeficiency
• Documented human immunodeficiency virus (HIV) infection
• History of autoimmune disease (including but not limited to systemic lupus erythematosus, antiphospholipid syndrome, Behcet's disease, autoimmune thyroid disease, polymyositis and dermatomyositis, scleroderma, or type 1 diabetes mellitus)
• Known coagulation disorder contraindicating intramuscular vaccination
• History of malignancy ≤5 years prior to signing informed consent/assent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
• A WOCBP who has a positive urine or serum pregnancy test before the first vaccination at Visit 1 (Day 1)
• Received any PCV or pneumococcal polysaccharide vaccine \<3 years before Visit 1 (Day 1)
• Five (5) years of age and has received \<3 doses of PCV
• Receiving immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease. Note: hydroxyurea is permitted
• Received immunoglobulin within 6 months before receipt of study vaccine
• Participated in another clinical study of an investigational product within 2 months before the beginning or anytime during the duration of the current clinical study. Participants enrolled in observational studies may be included
• Recent history (within the last year) of more than 3 inpatient hospitalizations

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (19)

Nemours/Alfred I. duPont Hospital for Children ( Site 0113)

Wilmington, Delaware, 19803, United States

Location

Children's Healthcare of Atlanta ( Site 0100)

Atlanta, Georgia, 30303, United States

Location

Children's Hospital of Michigan ( Site 0111)

Detroit, Michigan, 48201, United States

Location

Newark Beth Israel Medical Center ( Site 0115)

Newark, New Jersey, 07112, United States

Location

University of Rochester Medical Center ( Site 0105)

Rochester, New York, 14642, United States

Location

Cincinnati Children's Hospital Medical Center ( Site 0101)

Cincinnati, Ohio, 45229, United States

Location

Santa Casa de Misericordia de Belo Horizonte ( Site 0200)

Belo Horizonte, Minas Gerais, 30150-221, Brazil

Location

Hospital Santo Antonio - Obras Sociais Irma Dulce ( Site 0205)

Salvador, 40420-000, Brazil

Location

Santa Casa de Misericordia de Sao Paulo ( Site 0202)

São Paulo, 01221-900, Brazil

Location

Clinica de la Costa Ltda. ( Site 0300)

Barranquilla, Atlántico, 080020, Colombia

Location

Centro de Estudios en Infectologia Pediatrica SAS ( Site 0301)

Cali, Valle del Cauca Department, 760045, Colombia

Location

Fundacion Dominicana de Perinatologia PRO BEBE INC ( Site 0402)

Distrito Nacional, Santo Domingo Province, 10204, Dominican Republic

Location

Clinical Research Republica Dominicana ( Site 0401)

Santo Domingo, 10122, Dominican Republic

Location

Caimed Dominicana S.A.S ( Site 0400)

Santo Domingo, 10205, Dominican Republic

Location

Agia Sophia Children s Hospital ( Site 0700)

Athens, 115 27, Greece

Location

Hippokration General Hospital of Thessaloniki ( Site 0701)

Thessaloniki, 546 42, Greece

Location

Ospedale San Martino ( Site 0800)

Genova, 16132, Italy

Location

Cevaxin ( Site 0500)

Panama City, 0816-00383, Panama

Location

Cevaxin ( Site 0502)

Panama City, 0816-00383, Panama

Location

Related Publications (1)

• Quinn CT, Wiedmann RT, Jarovsky D, Lopez-Medina E, Rodriguez HM, Papa M, Boggio G, Shou Q, Dagan R, Richmond P, Feemster K, McFetridge R, Tamms G, Lupinacci R, Musey L, Bickham K. Safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in children with SCD: a V114-023 (PNEU-SICKLE) study. Blood Adv. 2023 Feb 14;7(3):414-421. doi: 10.1182/bloodadvances.2022008037.

  PMID: 36383730 DERIVED

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

13-valent pneumococcal vaccine

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Clinical Trials Disclosure
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2018
• First Posted: November 6, 2018
• Study Start: January 23, 2019
• Primary Completion: June 8, 2020
• Study Completion: June 8, 2020
• Last Updated: June 16, 2021
• Results First Posted: June 16, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share

Locations

US (6); BR (3); IT (1); DO (3); PA (2); GR (2); CO (2)