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

Phase 2

• Conditions: Infectious Disease
• Interventions: Biological: NU300; Biological: ActHIB; Biological: Prevnar 13

• Registration Number: NCT01732198
• Lead Sponsor: Nuron Biotech Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-19
• Study First Submitted QC: 2012-11-21
• Study First Posted: 2012-11-22
• Study Start: 2013-03
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-20
• Last Update Posted: 2013-09-23
• Primary Completion: 2014-01
• Study Completion: 2014-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NU300 and Prevnar 13	NU300	NU300 at a single dose of 0.5 mL IM
NU300 and Prevnar 13	Prevnar 13	NU300 at a single dose of 0.5 mL IM
ActHIB and Prevnar 13	ActHIB	ActHIB at a dose of 0.5 ml IM
ActHIB and Prevnar 13	Prevnar 13	ActHIB at a dose of 0.5 ml IM

Primary Outcome Measures

Name	Time	Method
safety and efficacy	one month	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

Name	Time	Method
Evaluate the individual IgG antibody quantitative response to the 13 antigens in Prevnar 13®	one month	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