This study is designed to describe the safety, tolerability, and immunogenicity of V114 in children with sickle cell disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
104
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
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
Nemours/Alfred I. duPont Hospital for Children ( Site 0113)
Wilmington, Delaware, United States
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Day 30
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Children's Healthcare of Atlanta ( Site 0100)
Atlanta, Georgia, United States
Children's Hospital of Michigan ( Site 0111)
Detroit, Michigan, United States
Newark Beth Israel Medical Center ( Site 0115)
Newark, New Jersey, United States
University of Rochester Medical Center ( Site 0105)
Rochester, New York, United States
Cincinnati Children's Hospital Medical Center ( Site 0101)
Cincinnati, Ohio, United States
Santa Casa de Misericordia de Belo Horizonte ( Site 0200)
Belo Horizonte, Minas Gerais, Brazil
Hospital Santo Antonio - Obras Sociais Irma Dulce ( Site 0205)
Salvador, Brazil
Santa Casa de Misericordia de Sao Paulo ( Site 0202)
São Paulo, Brazil
Clinica de la Costa Ltda. ( Site 0300)
Barranquilla, Atlántico, Colombia
...and 9 more locations
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30
Sera from participants was used to measure GMT of 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 using the multiplexed opsonophagocytic assay (MOPA).
Time frame: Day 30
Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30
IgG for 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 unique to V114 (22F and 33F) was determined using an electrochemiluminescence assay. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline (Day 1, pre-vaccination).
Time frame: Day 1 (Baseline) and Day 30
GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30
Activity for 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 unique to V114 (22F and 33F) was determined using a MOPA. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline (Day 1, pre-vaccination).
Time frame: Day 1 (Baseline) and Day 30