Study of PR5I, a Pediatric Combination Vaccine With Enhanced Hepatitis B Component Given Concomitantly With Prevnar®

Hepatitis B Clinical Trial

Official title:

A Randomized Trial to Assess the Immunogenicity and Safety of PR5I With an Adjuvant Composition Enhancement to the Hepatitis B Component and When Given Concomitantly With Prevnar®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00362427
• Other study ID #: PR504
• Status: Completed
• Phase: Phase 2
• First received: August 9, 2006
• Last updated: January 10, 2014
• Start date: August 2006
• Est. completion date: March 2009

Study information

• Verified date: January 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

PR5I, a hexavalent pediatric combination vaccine is being developed to reduce the number of injections during the first 2 years of life while providing a complete course of immunization against infection caused by H. influenzae type b, hepatitis B virus, Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, and poliovirus types 1, 2, and 3.

Primary Objective: To evaluate immunogenicity of PR5I with the adjuvant composition enhancement to the hepatitis B component when administered concomitantly with Prevnar®

Secondary Objectives: To assess the safety and immunogenicity of PR5I when administered concomitantly, or one month apart with Prevnar® or separately with licensed vaccines used for routine infant vaccination in Canada.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: March 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 42 Days to 89 Days

Eligibility

Inclusion Criteria:

• Infants aged 42 to 89 days inclusive on the day of inclusion.

• Born at full term of pregnancy (>37 weeks).

• Informed consent form signed by the parent(s) or legally authorized representative.

• Able to attend all scheduled visits and to comply with the study procedures.

• Parent or legally authorized representative has access to a telephone.

• Parent or legally authorized representative able to read and write in English or French.

Exclusion Criteria:

• Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.

• Planned participation in another clinical trial during the present trial period.

• Personal or immediate family history of congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy.

• Known or suspected systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the trial vaccine(s).

• Chronic illness that could interfere with trial conduct or completion.

• Received blood or blood-derived products since birth.

• Any vaccination preceding the first trial vaccination or planned in the 4 weeks after any trial vaccination (flu vaccine may be given a minimum of 4 weeks prior to the first study vaccination).

• Previous vaccination with any acellular pertussis- (DTaP) or whole cell pertussis- (DTwP) based combination vaccines, Haemophilus influenzae type b (Hib)-conjugate, poliovirus, hepatitis B, or pneumococcal conjugate vaccines.

• Coagulation disorder contraindicating IM vaccination.

• Clinically significant findings on review of systems (determined by investigator or sub-investigator to be sufficient for exclusion).

• Developmental delay or neurological disorder.

• Any condition which, in the opinion of the investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject.

• Documented Hepatitis B surface Antigen (HBsAg) seropositivity in the child or his/her mother.

• History of Hib, hepatitis B, diphtheria, tetanus, pertussis or poliovirus disease.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diphtheria
• Hepatitis
• Hepatitis A
• Hepatitis B
• Pertussis
• Polio
• Tetanus

Intervention

Biological:
• Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC
0.5 mL, 4 doses, IM
• Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC
0.5 Ml, 4 doses, IM
• Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC
0.5 mL, 4 doses, IM with concommitant vaccines

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To provide information concerning the immune response of subjects that received PR5I concomitantly with Prevnar		14 Months	No

External Links

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