A Phase 2, Multicenter, Open-label Study to Assess the Immunogenicity of an Investigational Hib Vaccine (NU300)in Toddlers

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®

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.

Study Overview

• Status: Unknown
• Conditions: Infectious Disease
• Intervention / Treatment: Biological: Prevnar 13; Biological: NU300; Biological: ActHIB

• Study Type: Interventional
• Enrollment (Anticipated): 220
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94611
  • Kentucky
    • Bardstown, Kentucky, United States, 40004

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Written informed consent obtained from the parent or guardian of the subject
2. 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.
3. Subjects for whom the investigator believes that the parent/guardian can and will comply with the requirements of the protocol
4. Subjects free of obvious health problems as established by medical history and clinical examination before entering the study

Exclusion Criteria:

1. Previous booster vaccination against Hib and/or Prevnar 13®
2. Any confirmed or suspected Haemophilus influenzae or pneumococcal illness.
3. 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).
4. Chronic administration of immunosuppressants or other immune-modifying drugs within 30 days prior to dosing in the study.
5. Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and/or clinical examination.
6. Early pre-term birth (delivery before 32 weeks).
7. Major congenital defects or serious chronic diseases, or serious conditions including history of seizures, apnea, etc.
8. 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)
9. 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]).
10. Known history of thrombocytopenia or any coagulation disorder.
11. Known hypersensitivity to any of the components of the vaccines.
12. Known hypersensitivity to latex.
13. The subject is unable to provide an adequate blood draw for immunogenicity assays, and safety panels at Visit 1

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NU300 and Prevnar 13; NU300 at a single dose of 0.5 mL IM	Biological: Prevnar 13; Biological: NU300
Active Comparator: ActHIB and Prevnar 13; ActHIB at a dose of 0.5 ml IM	Biological: Prevnar 13; Biological: ActHIB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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®.	one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	one month

Collaborators and Investigators

• Sponsor: Nuron Biotech Inc.

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Anticipated): January 1, 2014
• Study Completion (Anticipated): April 1, 2014

Study Registration Dates

• First Submitted: November 19, 2012
• First Submitted That Met QC Criteria: November 21, 2012
• First Posted (Estimate): November 22, 2012

Study Record Updates

• Last Update Posted (Estimate): September 23, 2013
• Last Update Submitted That Met QC Criteria: September 20, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Physiological Effects of Drugs; Immunologic Factors; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: CP-NU300-02