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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nuron Biotech Inc.
ClinicalTrials.gov Identifier:
NCT01732198
First received: November 19, 2012
Last updated: September 20, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Infectious Disease
Biological: NU300
Biological: ActHIB
Biological: Prevnar 13
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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®

Resource links provided by NLM:


Further study details as provided by Nuron Biotech Inc.:

Primary Outcome Measures:
  • safety and efficacy [ Time Frame: one month ] [ Designated as safety issue: Yes ]

    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® [ Time Frame: one month ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 220
Study Start Date: March 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NU300 and Prevnar 13
NU300 at a single dose of 0.5 mL IM
Biological: NU300 Biological: Prevnar 13
Active Comparator: ActHIB and Prevnar 13
ActHIB at a dose of 0.5 ml IM
Biological: ActHIB Biological: Prevnar 13

  Eligibility

Ages Eligible for Study:   12 Months to 15 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01732198

Locations
United States, California
Oakland, California, United States, 94611
United States, Kentucky
Bardstown, Kentucky, United States, 40004
Sponsors and Collaborators
Nuron Biotech Inc.
  More Information

No publications provided

Responsible Party: Nuron Biotech Inc.
ClinicalTrials.gov Identifier: NCT01732198     History of Changes
Other Study ID Numbers: CP-NU300-02
Study First Received: November 19, 2012
Last Updated: September 20, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Communicable Diseases
Infection

ClinicalTrials.gov processed this record on August 18, 2014