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Vaccine

NU300 and Prevnar 13 for Infectious Diseases

Phase 2
Waitlist Available
Research Sponsored by Nuron Biotech Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one month
Awards & highlights

Study Summary

Evaluate the safety and tolerability of a single booster dose of NU300, co-administered with Prevnar 13® over a 28 day period following the injection compared to a single booster of ACTHIB co-administered with Prevnar 13® over a 28 day period following the injection. Evaluate the immunogenicity, as determined by anti-PRP polysaccharide response, of a single booster dose of NU300 co-administered with Prevnar 13® compared to a single booster dose of ActHIB® co-administered with Prevnar 13®. Evaluate the individual IgG antibody quantitative response to the 13 antigens in Prevnar 13® following NU300 co-administration with Prevnar 13® compared to the IgG antibody response to the pneumococcal polysaccharides following ActHIB® co-administration with Prevnar 13® 28 days following injection.

Eligible Conditions
  • Infectious Diseases

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one month
This trial's timeline: 3 weeks for screening, Varies for treatment, and one month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
safety and efficacy
Secondary outcome measures
Evaluate the individual IgG antibody quantitative response to the 13 antigens in Prevnar 13®

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: NU300 and Prevnar 13Experimental Treatment2 Interventions
NU300 at a single dose of 0.5 mL IM
Group II: ActHIB and Prevnar 13Active Control2 Interventions
ActHIB at a dose of 0.5 ml IM
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Streptococcus pneumoniae type 19a capsular polysaccharide antigen
FDA approved

Find a Location

Who is running the clinical trial?

Nuron Biotech Inc.Lead Sponsor
1 Previous Clinical Trials
500 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Phase 2, Multicenter, Open-label Study to Assess the Immunogenicity of an Investigational Hib Vaccine (NU300)in Toddlers
2013. "A Phase 2, Multicenter, Open-label Study to Assess the Immunogenicity of an Investigational Hib Vaccine (NU300)in Toddlers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01732198.
~18 spots leftby Apr 2025
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