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

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-000898-30-DE
• Date of registration: 04/04/2006
• Prospective Registration: Yes
• Primary sponsor: Sanofi Pasteur Incorporated
• Public 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
• Scientific 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
• Date of first enrolment: 05/07/2006
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-000898-30
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Germany

Key inclusion & exclusion criteria

Inclusion criteria:
1. 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 9 months of life). The interval period between the 3rd dose of the primary series and the booster dose should be of at least 6 months.
2. Informed consent form signed by both parents or by the legal guardian.
3. Parents or legal guardian able to read and write the German language.
4. Parents or legal guardian able to attend all scheduled visits and to comply with study procedures.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Presence of fever (defined as rectal body temperature =38.0°C) reported within the last 72 hours
2. Moderate or severe acute illness with or without fever
3. Participation in another clinical trial in the 30 days preceding study vaccination.
4. Planned participation in another clinical trial during the present study period.
5. Immunisation with a pneumococcal vaccine prior to study vaccination or planned during the participation in the study.
6. Received more than 3 doses of a hexavalent vaccine prior to study vaccination.
7. Received any vaccination in the 30 days preceding the trial.
8. History of serological/microbiologically-confirmed diagnosis of infection due to pertussis, tetanus, diphtheria, poliomyelitis, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae.
9. 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).
10. Systemic or local hypersensitivity to any of the study vaccine components (including neomycin, streptomycin, polymyxin B and formaldehyde).
11. 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.
12. Blood or blood-derived products (immunoglobulins) received during 3 months prior to study vaccination.
13. Known HIV seropositivity.
14. Known thrombocytopenia or a bleeding disorder contraindicating I.M. vaccination.
15. History of encephalopathy seizures or progressive, evolving or unstable neurological condition.
16. 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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

PEDIACEL is a fully liquid combination vaccine indicated for infants and children for the prevention of five infectious diseases (diphtheria, tetanus, pertussis, poliomyelitis and infections caused by Haemophilus influenzae type b), as a booster dose administered to toddlers previously primed with three doses of a hexavalent vaccine.

Intervention(s)

Trade Name: PEDIACEL
Product Name: PEDIACEL
Product Code: HCPDT-IPV-PRP-T
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Diphtheria adsorbatum
Current Sponsor code: D
Other descriptive name: Purified Diphtheria Toxoid
Concentration unit: IU international unit(s)
Concentration type: not less then
Concentration number: 30-
INN or Proposed INN: Tetani adsorbatum
Current Sponsor code: T
Concentration unit: IU international unit(s)
Concentration type: not less then
Concentration number: 40-
INN or Proposed INN: Pertussis sine cellulis ex elementis praepartum adsorbatum (PT)
Current Sponsor code: PT
Other descriptive name: Pertussis Toxoid (PT)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 20-
INN or Proposed INN: Pertussis sine cellulis ex elementis praepartum adsorbatum (FHA)
Current Sponsor code: FHA
Other descriptive name: Purified Filamentous Haemagglutinin (FHA)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 20-
INN or Proposed INN: Pertussis sine cellulis ex elementis praepartum adsorbatum (FIM)
Current Sponsor code: FIM
Other descriptive name: Purified Fimbrial Agglutinogens 2 and 3 (FIM)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 5-
INN or Proposed INN: Pertussis sine cellulis ex elementis praepartum adsorbatum (PRN)
Current Sponsor code: PRN
Other descriptive name: Purified Pertactin (PRN)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 3-
INN or Proposed INN: Poliomyelitidis inactivatum stirpe 1
Current Sponsor code: IPV
Other descriptive name: Inactivated Type 1 Poliovirus (Mahoney)
Concentration type: equal
Concentration number: 40-D-antigen units
INN or Proposed INN: Poliomyelitidis inactivatum stirpe 2
Current Sponsor code: IPV
Other descriptive name: Inactivated Type 2 Poliovirus (MEF 1)
Concentration type: equal
Concentration number: 8 -D-antigen units
INN or Proposed INN: Poliomyeliti

Primary Outcome(s)

Main Objective: To evaluate the safety of PEDIACEL® booster dose by comparing the fever rates between PEDIACEL® and Infanrix® hexa vaccines when both are co-administered with Prevenar® to toddlers at 11-18 months of age.

Secondary Objective: 1. To show whether the incidence rate of fever (defined as rectal body temperature =38.0°C) reported within four days of booster vaccination is lower with PEDIACEL®.

2.To describe the incidence rate of severe fever (defined as rectal body temperature =39.6°C) within four days post-vaccination.

3.To describe the antibody responses to all antigens in PEDIACEL®, Infanrix® hexa, Prevenar® and ENGERIX®-B Kinder vaccines in a subgroup of subjects at baseline and post-vaccination.

Primary end point(s): Primary endpoint for analysis of safety is the fever rate reported within four days (Day 0-Day 3) of booster vaccination for both groups.

Secondary ID(s)

A5I19