Comparison of Safety and Immunogenicity of Pediacel™ and Infanrix™ IPV+Hib (Penta) Given in a 3 Dose Schedule in Infants

January 6, 2015 updated by: Sanofi Pasteur, a Sanofi Company

A Randomised, Controlled, Double-Blind Study of the Immunogenicity and Safety of PEDIACEL®, a Combined Diphtheria, Tetanus, Five Component Acellular Pertussis, Inactivated Poliomyelitis and Haemophilus Influenzae Type b Conjugate Vaccine (Adsorbed) Compared To Infanrix®-IPV+Hib When Both Vaccines Are Given to Infants Using a Three Dose Immunisation Schedule ("Nordic Schedule" 3-5-12 Months)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

807

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Espoo, Finland, 02100
      • Helsinki, Finland, 00100
      • Helsinki, Finland, 00930
      • Jarvenpaa, Finland, 04400
      • Jyvaskyla, Finland, 40100
      • Kotka, Finland, 48100
      • Lahti, Finland, 15140
      • Oulu, Finland, 90100
      • Pori, Finland, 28120
      • Tampere, Finland, 33520
      • Turku, Finland, 20520
      • Vantaa, Finland, 01300
      • Vantaa, Finland, 01600
  • Sweden
      • Ostersund, Sweden, S-831 83

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Infants aged 80 to 120 days inclusive on the day of inclusion.
  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Participants will receive PEDIACEL vaccine
Biological: DT5aP-IPV-Hib 5-component Pertussis vaccine
0.5 mL, IM
Other Names:
  • Pediacel™
Active Comparator: Group 2
Participants will receive Infanrix-IPV+Hib vaccines
Biological: Infanrix® -IPV+Hib
0.5 mL, IM
Other Names:
  • Infanrix®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To provide information concerning the immunogenicity of PEDIACEL® Vaccine.
Time Frame: 1 Month post-dose 3
1 Month post-dose 3

Secondary Outcome Measures

Outcome Measure
Time Frame
To provide information concerning the safety after administration of PEDIACEL® Vaccine
Time Frame: Entire study period
Entire study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

February 3, 2006

First Submitted That Met QC Criteria

February 3, 2006

First Posted (Estimate)

February 6, 2006

Study Record Updates

Last Update Posted (Estimate)

January 7, 2015

Last Update Submitted That Met QC Criteria

January 6, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5I15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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