Back to resultsA Phase 2, Multicenter, Open-label Study to Assess the Immunogenicity of an Investigational Hib Vaccine (NU300)in Toddlers
Primary Purpose
Infectious Disease
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NU300
ActHIB
Prevnar 13
Sponsored by
About this trial
This is an interventional prevention trial for Infectious Disease
Eligibility Criteria
Inclusion Criteria:
- Written informed consent obtained from the parent or guardian of the subject
- Male or female subjects 12-15 months of age at the time of booster vaccination, who had previously received complete primary vaccination series with a licensed Hib product and Prevnar 13® in accordance with the FDA approved labels.
- Subjects for whom the investigator believes that the parent/guardian can and will comply with the requirements of the protocol
- Subjects free of obvious health problems as established by medical history and clinical examination before entering the study
Exclusion Criteria:
- Previous booster vaccination against Hib and/or Prevnar 13®
- Any confirmed or suspected Haemophilus influenzae or pneumococcal illness.
- Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before and ending 28 days after administration of study vaccines (before the blood draw at Visit 2).
- Chronic administration of immunosuppressants or other immune-modifying drugs within 30 days prior to dosing in the study.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and/or clinical examination.
- Early pre-term birth (delivery before 32 weeks).
- Major congenital defects or serious chronic diseases, or serious conditions including history of seizures, apnea, etc.
- Concurrent participation in another clinical study at any time during the study period or within the previous 6 months in which the subject has been or will be exposed to an investigational or non-investigational product (pharmaceutical product, formula, or device)
- Presence of a moderate or severe illness with or without fever at the time of vaccination (fever is defined as a temperature of ≥ 38.0C [100.4F]).
- Known history of thrombocytopenia or any coagulation disorder.
- Known hypersensitivity to any of the components of the vaccines.
- Known hypersensitivity to latex.
- The subject is unable to provide an adequate blood draw for immunogenicity assays, and safety panels at Visit 1
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
NU300 and Prevnar 13
ActHIB and Prevnar 13
Arm Description
NU300 at a single dose of 0.5 mL IM
ActHIB at a dose of 0.5 ml IM
Outcomes
Primary Outcome Measures
safety and efficacy
Evaluate the safety and tolerability 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®, over a 28 day period following 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®.
Secondary Outcome Measures
Evaluate the individual IgG antibody quantitative response to the 13 antigens in 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
Full Information
NCT ID
NCT01732198
First Posted
November 19, 2012
Last Updated
September 20, 2013
Sponsor
Nuron Biotech Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01732198
Brief Title
A Phase 2, Multicenter, Open-label Study to Assess the Immunogenicity of an Investigational Hib Vaccine (NU300)in Toddlers
Official Title
A Phase 2, Multicenter, Randomized, Double-Blind, Immunogenicity, Reactogenicity, and Safety Study of NU300 Booster Dose Compared to ActHIB®, Both Co-administered With Prevnar 13® at 12-15 Months of Age, in Healthy Toddlers Who Have Received a Primary Series of a Licensed Hib Vaccine and Prevnar 13®
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
April 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nuron Biotech Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infectious Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NU300 and Prevnar 13
Arm Type
Experimental
Arm Description
NU300 at a single dose of 0.5 mL IM
Arm Title
ActHIB and Prevnar 13
Arm Type
Active Comparator
Arm Description
ActHIB at a dose of 0.5 ml IM
Intervention Type
Biological
Intervention Name(s)
NU300
Intervention Type
Biological
Intervention Name(s)
ActHIB
Intervention Type
Biological
Intervention Name(s)
Prevnar 13
Primary Outcome Measure Information:
Title
safety and efficacy
Description
Evaluate the safety and tolerability 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®, over a 28 day period following 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®.
Time Frame
one month
Secondary Outcome Measure Information:
Title
Evaluate the individual IgG antibody quantitative response to the 13 antigens in Prevnar 13®
Description
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
Time Frame
one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
15 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Written informed consent obtained from the parent or guardian of the subject
Male or female subjects 12-15 months of age at the time of booster vaccination, who had previously received complete primary vaccination series with a licensed Hib product and Prevnar 13® in accordance with the FDA approved labels.
Subjects for whom the investigator believes that the parent/guardian can and will comply with the requirements of the protocol
Subjects free of obvious health problems as established by medical history and clinical examination before entering the study
Exclusion Criteria:
Previous booster vaccination against Hib and/or Prevnar 13®
Any confirmed or suspected Haemophilus influenzae or pneumococcal illness.
Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before and ending 28 days after administration of study vaccines (before the blood draw at Visit 2).
Chronic administration of immunosuppressants or other immune-modifying drugs within 30 days prior to dosing in the study.
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and/or clinical examination.
Early pre-term birth (delivery before 32 weeks).
Major congenital defects or serious chronic diseases, or serious conditions including history of seizures, apnea, etc.
Concurrent participation in another clinical study at any time during the study period or within the previous 6 months in which the subject has been or will be exposed to an investigational or non-investigational product (pharmaceutical product, formula, or device)
Presence of a moderate or severe illness with or without fever at the time of vaccination (fever is defined as a temperature of ≥ 38.0C [100.4F]).
Known history of thrombocytopenia or any coagulation disorder.
Known hypersensitivity to any of the components of the vaccines.
Known hypersensitivity to latex.
The subject is unable to provide an adequate blood draw for immunogenicity assays, and safety panels at Visit 1
Facility Information:
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase 2, Multicenter, Open-label Study to Assess the Immunogenicity of an Investigational Hib Vaccine (NU300)in Toddlers
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