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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

460 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2009-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diphtheria Pertussis Polio Hepatitis B Tetanus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group A

Group Type EXPERIMENTAL

Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC

Intervention Type BIOLOGICAL

0.5 mL, 4 doses, IM

Group B

Group Type EXPERIMENTAL

Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC

Intervention Type BIOLOGICAL

0.5 Ml, 4 doses, IM

Group C

Group Type ACTIVE_COMPARATOR

Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC

Intervention Type BIOLOGICAL

0.5 mL, 4 doses, IM with concommitant vaccines

Interventions

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Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC

0.5 mL, 4 doses, IM

Intervention Type BIOLOGICAL

Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC

0.5 Ml, 4 doses, IM

Intervention Type BIOLOGICAL

Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC

0.5 mL, 4 doses, IM with concommitant vaccines

Intervention Type BIOLOGICAL

Other Intervention Names

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PR5I PR5I PR5I PENTACEL™ NGERIX-B®

Eligibility Criteria

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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.

Minimum Eligible Age

42 Days

Maximum Eligible Age

89 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes