Study to Compare Booster Vaccination With Pediacel® to Infanrix® Hexa When Both Are Co-Administered With Prevenar®

Healthy Clinical Trial

Official title:

Safety and Immunogenicity of Booster Vaccination With PEDIACEL®, a Combined Diphtheria, Tetanus, Five Component Acellular Pertussis, Inactivated Poliomyelitis and Haemophilus Influenzae Type b Conjugate Vaccine (Adsorbed), Compared to Booster Vaccination With Infanrix® Hexa When Both Vaccines Are Co-Administered With Prevenar® to Toddlers 11-18 Months of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00355654
• Other study ID #: A5I19
• Status: Completed
• Phase: Phase 3
• First received: July 20, 2006
• Last updated: January 6, 2015
• Start date: September 2006
• Est. completion date: July 2008

Study information

• Verified date: January 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to provide data on the safety and immunogenicity of Pediacel® to allow its use as a fourth dose administered to 11-18 months old toddlers at the same time as Prevenar®.

Primary Objective:

To evaluate the safety of Pediacel® booster dose co-administered with Prevenar® to toddlers at 11-18 months of age.

Secondary Objectives:

• To describe the incidence rate of severe fever within four days post-vaccination

• To describe the antibody responses to all antigens in a subgroup of subjects at baseline and post-vaccination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 847
• Est. completion date: July 2008
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Months to 18 Months

Eligibility

Inclusion Criteria:

• Toddlers 11-18 months of age (from the 11th month birthday to one day prior to the 19th month birthday) who previously received the primary immunisation series with a hexavalent vaccine (consisting of three doses of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and Haemophilus influenza type b combined vaccine administered within the first 6 months of life)

• Informed consent form signed by both parents or by the legal guardian

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

• Parents or a 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 study vaccination

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

• Immunisation with a pneumococcal vaccine prior to study vaccination or planned during the participation in the study

• Received more than 3 doses of a hexavalent vaccine prior to study vaccination

• Received any vaccination in the 30 days preceding the trial

• History of serological/microbiologically-confirmed diagnosis of infection due to pertussis, tetanus, diphtheria, poliomyelitis, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae

• 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 30 days prior to study vaccination)

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

• History of a life-threatening reaction (such as encephalopathy, Hypotonic-Hyporesponsive Episode (HHE), 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 during 3 months prior to study vaccination

• Known HIV seropositivity

• Known thrombocytopenia or a 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: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy
• Infant

Intervention

Biological:
• DT5aP-IPV-Hib 5-component Pertussis vaccine
0.5 mL, IM
• DT3aP-HBs-IPV
0.5 mL, IM

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To provide information concerning the safety after administration of PEDIACEL® booster dose		0 to 3 Days post-vaccination	Yes
Secondary	To provide information concerning the safety (as fever rate) after administration of PEDIACEL® Vaccine		4 days post-vaccination	Yes

External Links

•   Link
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