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

Primary Purpose

Diphtheria, Tetanus, Pertussis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
PEDIACEL® and Prevenar®
Infanrix®-IPV+Hib and Prevenar®
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diphtheria focused on measuring Diphtheria, Tetanus, Pertussis, Poliomyelitis, Haemophilus influenzae type b, Pneumococcal infections

Eligibility Criteria

55 Days - 75 Days (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

PEDIACEL co-administered with Prevenar

Infanrix-IPV+Hib co-administered with Prevenar

Outcomes

Primary Outcome Measures

To provide information concerning the immunogenicity of PEDIACEL® and Infanrix®-IPV+Hib

Secondary Outcome Measures

To provide information concerning the safety after administration of PEDIACEL® and Infanrix®-IPV+Hib

Full Information

First Posted
June 21, 2006
Last Updated
June 1, 2016
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00343421
Brief Title
Study to Compare Pediacel® to Infanrix®-IPV+Hib When Both Are Co-Administered With Prevenar® in Infants and Toddlers
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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®.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diphtheria, Tetanus, Pertussis, Poliomyelitis, Haemophilus Influenzae Type b
Keywords
Diphtheria, Tetanus, Pertussis, Poliomyelitis, Haemophilus influenzae type b, Pneumococcal infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
588 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
PEDIACEL co-administered with Prevenar
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Infanrix-IPV+Hib co-administered with Prevenar
Intervention Type
Biological
Intervention Name(s)
PEDIACEL® and Prevenar®
Other Intervention Name(s)
PEDIACEL®: DT5aP-IPV-Hib 5-component Pertussis vaccine, Prevenar®: Pneumococcal saccharide conj. vaccine, adsorbed
Intervention Description
0.5 mL each, IM (opposite thigh)
Intervention Type
Biological
Intervention Name(s)
Infanrix®-IPV+Hib and Prevenar®
Other Intervention Name(s)
Infanrix®-IPV+Hib: DTap, IPV and adsorbed conjugated Hib, Prevenar®: Pneumococcal saccharide conj vaccine, adsorbed.
Intervention Description
0.5 mL each, IM (opposite thigh)
Primary Outcome Measure Information:
Title
To provide information concerning the immunogenicity of PEDIACEL® and Infanrix®-IPV+Hib
Time Frame
1 month post-vaccination
Secondary Outcome Measure Information:
Title
To provide information concerning the safety after administration of PEDIACEL® and Infanrix®-IPV+Hib
Time Frame
Entire study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Days
Maximum Age & Unit of Time
75 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi Pasteur Inc.
Official's Role
Study Director
Facility Information:
City
Paris
Country
France
City
Poznan
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
21807056
Citation
Grimprel E, Wysocki J, Boisnard F, Thomas S, Mwawasi G, Reynolds D. Immunogenicity and safety of fully liquid DTaP(5)-IPV-Hib compared with DTaP(3)-IPV/Hib when both coadministered with a heptavalent pneumococcal conjugate vaccine (PCV7) at 2, 3, 4, and 12 to 18 months of age: a phase III, single-blind, randomised, controlled, multicentre study. Vaccine. 2011 Oct 6;29(43):7370-8. doi: 10.1016/j.vaccine.2011.07.078. Epub 2011 Jul 30.
Results Reference
result
Links:
URL
http://www.sanofipasteur.com
Description
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Study to Compare Pediacel® to Infanrix®-IPV+Hib When Both Are Co-Administered With Prevenar® in Infants and Toddlers

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