NCT00362427

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
460

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2006

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 10, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

January 14, 2014

Status Verified

January 1, 2014

Enrollment Period

2.5 years

First QC Date

August 9, 2006

Last Update Submit

January 10, 2014

Conditions

DiphtheriaPertussisPolioHepatitis BTetanus

Keywords

Hepatitis BPertussisDiphtheriaTetanusH. influenzae type bPolio

Outcome Measures

Primary Outcomes (1)

  • To provide information concerning the immune response of subjects that received PR5I concomitantly with Prevnar

    14 Months

Study Arms (3)

Group A

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

Group B

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

Group C

ACTIVE COMPARATOR
Biological: Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC

Interventions

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

0.5 mL, 4 doses, IM

Also known as: PR5I
Group A

Eligibility Criteria

Age42 Days - 89 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Coquitlam, British Columbia, V3C 4J2, Canada

Location

Unknown Facility

Surrey, British Columbia, V3R 8P8, Canada

Location

Unknown Facility

Winnipeg, Manitoba, R3E 3P4, Canada

Location

Unknown Facility

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Unknown Facility

Ottawa, Ontario, K1S 0G8, Canada

Location

Unknown Facility

Beauport, Quebec, G1E 7G9, Canada

Location

Unknown Facility

Montreal, Quebec, H3H 1P3, Canada

Location

Unknown Facility

Montreal, Quebec, H3T 1C5, Canada

Location

Related Publications (2)

  • 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.

    PMID: 24346596DERIVED

  • 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.

    PMID: 23241989DERIVED

Related Links

MeSH Terms

Conditions

DiphtheriaWhooping CoughPoliomyelitisHepatitis BTetanusHaemophilus Infections

Interventions

Haemophilus influenzae-type b polysaccharide-Neisseria meningitidis outer membrane protein conjugate vaccinepentacel

Condition Hierarchy (Ancestors)

Corynebacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsBordetella InfectionsGram-Negative Bacterial InfectionsRespiratory Tract InfectionsRespiratory Tract DiseasesMyelitisCentral Nervous System InfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeuroinflammatory DiseasesNeuromuscular DiseasesBlood-Borne InfectionsCommunicable DiseasesHepadnaviridae InfectionsDNA Virus InfectionsHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesClostridium InfectionsPasteurellaceae Infections

Study Officials

  • Medical Director

    Sanofi Pasteur Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2006

First Posted

August 10, 2006

Study Start

August 1, 2006

Primary Completion

February 1, 2009

Study Completion

March 1, 2009

Last Updated

January 14, 2014

Record last verified: 2014-01

Locations

CA(8)