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

NCT03731182 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2021-06-16

Study results available
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Summary

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

Conditions

  • Pneumococcal Infections

Interventions

BIOLOGICAL

V114

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

BIOLOGICAL

Prevnar 13™

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

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-23
Primary Completion
2020-06-08
Completion
2020-06-08
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Colombia
  • Dominican Republic
  • Greece
  • Italy
  • Panama

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03731182 on ClinicalTrials.gov