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

Sponsor

Sanofi Pasteur, a Sanofi Company (Industry)

Overall Status

Completed

CT.gov ID

NCT00287092

Collaborator

(none)

807

Enrollment

Locations

Arms

Duration (Months)

57.6

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pertussis Diphtheria Tetanus Poliomyelitis Haemophilus Influenzae Type b	Biological: DT5aP-IPV-Hib 5-component Pertussis vaccine Biological: Infanrix® -IPV+Hib	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

807 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

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)

Study Start Date :

Feb 1, 2006

Actual Primary Completion Date :

May 1, 2007

Actual Study Completion Date :

Sep 1, 2008

Arms and Interventions

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®

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®

Outcome Measures

Primary Outcome Measures

To provide information concerning the immunogenicity of PEDIACEL® Vaccine. [1 Month post-dose 3]

Secondary Outcome Measures

To provide information concerning the safety after administration of PEDIACEL® Vaccine [Entire study period]

Eligibility Criteria

Criteria

Ages Eligible for Study:

80 Days to 120 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	City	Country	Postal Code
1	Espoo	Finland	02100
2	Helsinki	Finland	00100
3	Helsinki	Finland	00930
4	Jarvenpaa	Finland	04400
5	Jyvaskyla	Finland	40100
6	Kotka	Finland	48100
7	Lahti	Finland	15140
8	Oulu	Finland	90100
9	Pori	Finland	28120
10	Tampere	Finland	33520
11	Turku	Finland	20520
12	Vantaa	Finland	01300
13	Vantaa	Finland	01600
14	Ostersund	Sweden	S-831 83