Study to Compare Pediacel® to Infanrix®-IPV+Hib When Both Are Co-Administered With Prevenar® in Infants and Toddlers

Tetanus Clinical Trial

Official title:

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 Co-Administered With Prevenar® to Infants and Toddlers at 2, 3, 4 and 12-18 Months of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00343421
• Other study ID #: A5I16
• Status: Completed
• Phase: Phase 3
• First received: June 21, 2006
• Last updated: June 1, 2016
• Start date: July 2006
• Est. completion date: June 2009

Study information

• Verified date: June 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Poland: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate safety and immunogenicity of Pediacel® in infants and toddlers when given at 2,3,4 and 12-18 months of age.

Primary Objectives:

• To compare the post-dose 3 immunogenicity of Pediacel® to Infanrix®-IPV+Hib when both are co-administered with Prevenar®.

• To describe the post-dose 3 pertussis antibody responses.

Secondary Objectives:

• To compare the post-dose 4 immunogenicity of Pediacel® to Infanrix®-IPV+Hib when both are co-administered with Prevenar®.

• To describe the safety after each vaccination following co-administration with Prevenar®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 588
• Est. completion date: June 2009
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Days to 75 Days

Eligibility

Inclusion Criteria:

• Infants 55 to 75 days old, inclusive on the day of first vaccination

• Born at full term of pregnancy (> 37 weeks)

• Informed consent form signed by the parent(s) or the legal guardian

• Parents or the legal guardian able to read and write in the local language

• Parent(s) or the legal guardian able to attend all scheduled visits and to comply with the study procedures.

Exclusion Criteria:

• Presence of fever (defined as rectal body temperature = 38.0°C) reported within the last 72 hours

• Moderate or severe acute illness with or without fever

• Participation in another clinical trial in the 30 days preceding first study vaccination

• Planned participation in another clinical trial during the present study period

• Received diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b or a pneumococcal vaccine separately or in combination prior to study vaccination

• Received any vaccination in the 30 days preceding the first study vaccination and/or is planning any vaccination within 6 weeks following any of the study vaccinations

• Congenital or acquired humoral/cellular immunodeficiency or immunosuppressive therapy such as long-term systemic corticosteroids therapy (= 2 mg/kg/day prednisone equivalent for = 14 days) in the previous 30 days

• Systemic or local hypersensitivity to any of the study vaccine components (including neomycin, streptomycin, polymyxin B and formaldehyde)

• History of life-threatening reaction(s) (such as encephalopathy, Hypotonic-Hyporesponsive Episode, rectal body temperature = 40.0°C, convulsions with or without fever) to any vaccine containing the same components as the study vaccines

• Blood or blood-derived products (immunoglobulins) received since birth

• Known Human immunodeficiency virus (HIV) seropositivity

• Known thrombocytopenia or other bleeding disorder contraindicating intramuscular vaccination

• History of encephalopathy, seizures or progressive, evolving or unstable neurological condition

• Clinically significant findings on review of systems that might interfere with study vaccination or which, in the opinion of the Investigator, would interfere with the evaluation of the study vaccine/objectives or pose a health risk to the subject.

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Biological:
• PEDIACEL® and Prevenar®
0.5 mL each, IM (opposite thigh)
• Infanrix®-IPV+Hib and Prevenar®
0.5 mL each, IM (opposite thigh)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Countries where clinical trial is conducted

France,  Poland, 

References & Publications (1)

Grimprel E, Wysocki J, Boisnard F, Thomas S, Mwawasi G, Reynolds D. Immunogenicity and safety of fully liquid DTaP5-IPV-Hib compared with DTaP3-IPV/Hib when both coadministered with a heptavalent pneumococcal conjugate vaccine (PCV7) at 2, 3, 4, and 12 to — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To provide information concerning the immunogenicity of PEDIACEL® and Infanrix®-IPV+Hib		1 month post-vaccination	No
Secondary	To provide information concerning the safety after administration of PEDIACEL® and Infanrix®-IPV+Hib		Entire study	Yes

External Links

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