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

Tetanus Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00287092
• Other study ID #: A5I15
• Status: Completed
• Phase: Phase 3
• First received: February 3, 2006
• Last updated: January 6, 2015
• Start date: February 2006
• Est. completion date: September 2008

Study information

• Verified date: January 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines AgencySweden: Swedish National Council on Medical Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 807
• Est. completion date: September 2008
• Est. primary completion date: May 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 80 Days to 120 Days

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diphtheria
• Haemophilus Influenzae Type b
• Influenza, Human
• Pertussis
• Poliomyelitis
• Tetanus
• Whooping Cough

Intervention

Biological:
• DT5aP-IPV-Hib 5-component Pertussis vaccine
0.5 mL, IM
• Infanrix® -IPV+Hib
0.5 mL, IM

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Countries where clinical trial is conducted

Finland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To provide information concerning the immunogenicity of PEDIACEL® Vaccine.		1 Month post-dose 3	No
Secondary	To provide information concerning the safety after administration of PEDIACEL® Vaccine		Entire study period	Yes

External Links

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