NCT00287092

Brief Summary

Pediacel™ is currently licensed in the UK for use as a 3 dose regimen for the active immunisation of infants against Diphtheria, Tetanus, Pertussis, Poliomyelitis and invasive infections caused by Haemophilus influenzae type b. However there are currently no clinical data supporting the use of Pediacel™ using a 3, 5, and 12 months of age vaccination schedule. This study is designed to provide safety and immunogenicity data to support the use of Pediacel™ according to a 3, 5, and 12 months schedule.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
807

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2006

Typical duration for phase_3

Geographic Reach
2 countries

14 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

February 1, 2006

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 6, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

January 7, 2015

Status Verified

January 1, 2015

Enrollment Period

1.2 years

First QC Date

February 3, 2006

Last Update Submit

January 6, 2015

Conditions

PertussisDiphtheriaTetanusPoliomyelitisHaemophilus Influenzae Type b

Keywords

Haemophilus influenzae type b;Corynebacterium diphtheriae;Clostridium tetani;Bordetella pertussis;poliovirus types 1, 2 and 3;Vero cell;Influenza;Diphtheria

Outcome Measures

Primary Outcomes (1)

  • To provide information concerning the immunogenicity of PEDIACEL® Vaccine.

    1 Month post-dose 3

Secondary Outcomes (1)

  • To provide information concerning the safety after administration of PEDIACEL® Vaccine

    Entire study period

Study Arms (2)

Group 1

EXPERIMENTAL

Participants will receive PEDIACEL vaccine

Biological: DT5aP-IPV-Hib 5-component Pertussis vaccine

Group 2

ACTIVE COMPARATOR

Participants will receive Infanrix-IPV+Hib vaccines

Biological: Infanrix® -IPV+Hib

Interventions

DT5aP-IPV-Hib 5-component Pertussis vaccineBIOLOGICAL

0.5 mL, IM

Also known as: Pediacel™
Group 1
Infanrix® -IPV+HibBIOLOGICAL

0.5 mL, IM

Also known as: Infanrix®
Group 2

Eligibility Criteria

Age80 Days - 120 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 other legal representative according to local regulations
  • Parent(s) or legal representative able to attend all scheduled visits and to understand and comply with the study procedures (able to read and write; access to a telephone).

You may not qualify if:

  • Rectal temperature ≥ 38.0°C
  • Moderate or severe acute illness with or without fever
  • Participation in another clinical trial in the 4 weeks preceding the first trial vaccination
  • Having received any DTaP, IPV, or Hib vaccines prior to study initiation or any vaccination in the 4 weeks preceding the first trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Known history of diphtheria, tetanus, pertussis, H. influenzae type b infections, poliomyelitis
  • Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
  • Systemic hypersensitivity to any of the vaccine components (including neomycin, streptomycin, polymyxin B and formaldehyde)
  • History of a life-threatening reaction (such as encephalopathy, Hypotonic Hyporesponsive Episode, severe fever, convulsions, etc.) to the trial vaccine or a vaccine containing the same substances
  • Blood or blood-derived products (immunoglobulins) received in the past 4 weeks
  • Vaccination planned in the 6 weeks following any trial vaccination
  • Known HIV seropositivity
  • Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
  • History of seizures or progressive, evolving or unstable neurological condition
  • Clinically significant findings on review of systems that might interfere with correct vaccination or which, in the opinion of the Investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Unknown Facility

Espoo, 02100, Finland

Location

Unknown Facility

Helsinki, 00100, Finland

Location

Unknown Facility

Helsinki, 00930, Finland

Location

Unknown Facility

Jarvenpaa, 04400, Finland

Location

Unknown Facility

Jyväskylä, 40100, Finland

Location

Unknown Facility

Kotka, 48100, Finland

Location

Unknown Facility

Lahti, 15140, Finland

Location

Unknown Facility

Oulu, 90100, Finland

Location

Unknown Facility

Pori, 28120, Finland

Location

Unknown Facility

Tampere, 33520, Finland

Location

Unknown Facility

Turku, 20520, Finland

Location

Unknown Facility

Vantaa, 01300, Finland

Location

Unknown Facility

Vantaa, 01600, Finland

Location

Unknown Facility

Östersund, S-831 83, Sweden

Location

Related Publications (1)

  • Vesikari T, Silfverdal SA, Boisnard F, Thomas S, Mwawasi G, Reynolds D. Randomized, controlled, multicenter study of the immunogenicity and safety of a fully liquid combination diphtheria-tetanus toxoid-five-component acellular pertussis (DTaP5), inactivated poliovirus (IPV), and haemophilus influenzae type b (Hib) vaccine compared with a DTaP3-IPV/Hib vaccine administered at 3, 5, and 12 months of age. Clin Vaccine Immunol. 2013 Oct;20(10):1647-53. doi: 10.1128/CVI.00414-13. Epub 2013 Aug 21.

    PMID: 23966556DERIVED

Related Links

MeSH Terms

Conditions

Whooping CoughDiphtheriaTetanusPoliomyelitisHaemophilus InfectionsInfluenza, Human

Interventions

diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis -Haemophilus influenzae type b conjugate vaccineDiphtheria-Tetanus-acellular Pertussis Vaccines

Condition Hierarchy (Ancestors)

Bordetella InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsRespiratory Tract DiseasesCorynebacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsClostridium InfectionsMyelitisCentral Nervous System InfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeuroinflammatory DiseasesNeuromuscular DiseasesPasteurellaceae InfectionsOrthomyxoviridae Infections

Intervention Hierarchy (Ancestors)

Pertussis VaccineBacterial VaccinesVaccinesBiological ProductsComplex MixturesDiphtheria ToxoidToxoidsTetanus ToxoidVaccines, CombinedVaccines, AcellularVaccines, Subunit

Study Officials

  • Medical Director

    Sanofi Pasteur Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2006

First Posted

February 6, 2006

Study Start

February 1, 2006

Primary Completion

May 1, 2007

Study Completion

September 1, 2008

Last Updated

January 7, 2015

Record last verified: 2015-01

Locations

SE(1)FI(13)