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

NCT ID: NCT00343421

Last Updated: 2016-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 588 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2009-06-30

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®.

Conditions

Diphtheria; Tetanus; Pertussis; Poliomyelitis; Haemophilus Influenzae Type b

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Group 1

PEDIACEL co-administered with Prevenar

Group Type: EXPERIMENTAL

PEDIACEL® and Prevenar®

Intervention Type: BIOLOGICAL

0.5 mL each, IM (opposite thigh)

Group 2

Infanrix-IPV+Hib co-administered with Prevenar

Group Type: ACTIVE_COMPARATOR

Infanrix®-IPV+Hib and Prevenar®

Intervention Type: BIOLOGICAL

0.5 mL each, IM (opposite thigh)

Interventions

PEDIACEL® and Prevenar®

0.5 mL each, IM (opposite thigh)

Intervention Type: BIOLOGICAL

Infanrix®-IPV+Hib and Prevenar®

0.5 mL each, IM (opposite thigh)

Intervention Type: BIOLOGICAL

Other Intervention Names

PEDIACEL®: DT5aP-IPV-Hib 5-component Pertussis vaccine; Prevenar®: Pneumococcal saccharide conj. vaccine, adsorbed; Infanrix®-IPV+Hib: DTap, IPV and adsorbed conjugated Hib; Prevenar®: Pneumococcal saccharide conj vaccine, adsorbed.

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.

• Minimum Eligible Age: 55 Days
• Maximum Eligible Age: 75 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Sanofi Pasteur Inc.

Locations

Paris, , France

Poznan, , Poland

Countries

France; Poland

References

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.

Reference Type: RESULT

PMID: 21807056 (View on PubMed)

Related Links

http://www.sanofipasteur.com

Related Info

Other Identifiers

A5I16

Identifier Type: -

Identifier Source: org_study_id