A phase IIIb, open, controlled study to evaluate the immunogenicity, and safety of 7PCV Prevenar vaccine in pre-term infants

• Conditions: Premature children suffer from large variety of different accompanying diseases. Pneumoccocal diseases creates substantial proportion especially in children with undergoing diseases of respiratory tract and the courses of illnesses are overall more serious . Immunization by 7-PCV decreases a risk of pneumococcal complications – meningitis, pneumonia, septicemia etc. However, limited data on immunogenicity when using in pre-term infants in the Czech Republic exist.; MedDRA version: 9.1Level: LLTClassification code 10054047Term: Pneumococcal sepsis; MedDRA version: 9.1Level: LLTClassification code 10027253Term: Meningitis pneumococcal

• Registration Number: EUCTR2007-001707-38-CZ
• Lead Sponsor: niversity Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Male or female between, and including 10-14 weeks of age at the time of first vaccination·
Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits).
Written informed consent obtained from the parent or guardian of the subject.·
Born after a gestation period between 25 and 37 weeks in study group and between 38 and 42 weeks in control group.
Birth weight in study group more than 500g and in control group more than 2500g.
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

Usee of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the entire study period for each age-group.
Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before and ending one month after each dose of vaccine(s).
Previous vaccination against S. pneumoniae.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including diphtheria toxoid.
History of seizures or neurological disease.
Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea or mild upper respiratory infections with or without low-grade fever, i.e oral/axillary/tympanic temperature <37.5°C / rectal temperature <38.0°C).·
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
A family history of congenital or hereditary immunodeficiency.·
Administration of immunoglobulins and/or any blood products since birth or planned administration during the entire study period.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified