Clinical trial NCT00362427: Study of PR5I, a Pediatric Combination Vaccine With Enhanced Hepatitis B Component Given Concomitantly With Prevnar®
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®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diphtheria
Pertussis
Polio
Hepatitis B
Tetanus
Keywords: Hepatitis B
Pertussis
Diphtheria
Tetanus
H. influenzae type b
Polio
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2006-08-10
Enrollment: 460
Sex: ALL
Minimum age (years): 42
Maximum age (years): 89
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: To provide information concerning the immune response of subjects that received PR5I concomitantly with Prevnar
timeFrame: 14 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Coquitlam
country: Canada
state: British Columbia
city: Surrey
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Halifax
country: Canada
state: Nova Scotia
city: Ottawa
country: Canada
state: Ontario
city: Beauport
country: Canada
state: Quebec
city: Montréal
country: Canada
state: Quebec
city: Montréal
country: Canada
state: Quebec
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Halperin SA, Tapiero B, Dionne M, Meekison W, Diaz-Mitoma F, Zickler P, Rubin E, Embree J, Bhuyan P, Lee A, Li M, Tomovici A. Safety and immunogenicity of a toddler dose following an infant series of a hexavalent diphtheria, tetanus, acellular pertussis, inactivated poliovirus, Haemophilus influenzae type b, hepatitis B vaccine administered concurrently or at separate visits with a heptavalent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2014 Jan;33(1):73-80. doi: 10.1097/01.inf.0000437806.76221.20.
citation: Tapiero B, Halperin SA, Dionne M, Meekison W, Diaz-Mitoma F, Zickler P, Rubin E, Embree J, Bhuyan P, Lee AW, Li M, Tomovici A. Safety and immunogenicity of a hexavalent vaccine administered at 2, 4 and 6 months of age with or without a heptavalent pneumococcal conjugate vaccine: a randomized, open-label study. Pediatr Infect Dis J. 2013 Jan;32(1):54-61. doi: 10.1097/INF.0b013e3182717edf.