Study to Compare Pediacel® to Infanrix®-IPV+Hib When Both Are Co-Administered With Prevenar® in Infants and Toddlers
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ClinicalTrials.gov Identifier: NCT00343421 |
Recruitment Status :
Completed
First Posted : June 23, 2006
Last Update Posted : June 3, 2016
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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®.
Condition or disease | Intervention/treatment | Phase |
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Diphtheria Tetanus Pertussis Poliomyelitis Haemophilus Influenzae Type b | Biological: PEDIACEL® and Prevenar® Biological: Infanrix®-IPV+Hib and Prevenar® | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 588 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Prevention |
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 Start Date : | July 2006 |
Actual Primary Completion Date : | June 2008 |
Actual Study Completion Date : | June 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: Group 1
PEDIACEL co-administered with Prevenar
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Biological: PEDIACEL® and Prevenar®
0.5 mL each, IM (opposite thigh)
Other Names:
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Active Comparator: Group 2
Infanrix-IPV+Hib co-administered with Prevenar
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Biological: Infanrix®-IPV+Hib and Prevenar®
0.5 mL each, IM (opposite thigh)
Other Names:
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- To provide information concerning the immunogenicity of PEDIACEL® and Infanrix®-IPV+Hib [ Time Frame: 1 month post-vaccination ]
- To provide information concerning the safety after administration of PEDIACEL® and Infanrix®-IPV+Hib [ Time Frame: Entire study ]

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Ages Eligible for Study: | 55 Days to 75 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00343421
France | |
Paris, France | |
Poland | |
Poznan, Poland |
Study Director: | Medical Director | Sanofi Pasteur Inc. |
Publications of Results:
Responsible Party: | Sanofi Pasteur, a Sanofi Company |
ClinicalTrials.gov Identifier: | NCT00343421 |
Other Study ID Numbers: |
A5I16 |
First Posted: | June 23, 2006 Key Record Dates |
Last Update Posted: | June 3, 2016 |
Last Verified: | June 2016 |
Diphtheria Tetanus Pertussis |
Poliomyelitis Haemophilus influenzae type b Pneumococcal infections |
Influenza, Human Whooping Cough Tetanus Diphtheria Poliomyelitis Tetany Respiratory Tract Infections Infections Orthomyxoviridae Infections RNA Virus Infections Virus Diseases Respiratory Tract Diseases Bordetella Infections Gram-Negative Bacterial Infections Bacterial Infections |
Bacterial Infections and Mycoses Clostridium Infections Gram-Positive Bacterial Infections Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases Hypocalcemia Calcium Metabolism Disorders Metabolic Diseases Corynebacterium Infections Actinomycetales Infections Myelitis Central Nervous System Infections Enterovirus Infections Picornaviridae Infections |