Study to Evaluate the Safety and Immunogenicity of a 10-valent Pneumococcal Conjugate Vaccine in Preterm Infants
- Conditions
- Three dose primary vaccination of preterm infants between 8-16 weeks (56-118 days) of age at the time of first vaccination against Streptococcus pneumoniae.MedDRA version: 14.1Level: LLTClassification code 10018953Term: Haemophilus influenzae meningitisSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.1Level: LLTClassification code 10042194Term: Streptococcus pneumoniae meningitisSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.1Level: LLTClassification code 10042196Term: Streptococcus pneumoniae secondary bacterial infection of acute bronchitisSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.1Level: LLTClassification code 10018954Term: Haemophilus influenzae secondary bacterial infection of acute bronchitisSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.1Level: LLTClassification code 10018952Term: Haemophilus influenzae infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.1Level: LLTClassification code 10035680Term: Pneumonia due to Haemophilus influenzae (H. influenzae)System Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.1Level: LLTClassification code 10054642Term: Streptococcus pneumoniae septicemiaSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.1Level: LLTClassification code 10042195Term: Streptococcus pneumoniae pneumoniaSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.1Level: LLTClassification code 10058214Term: Septicaemia due to haemophilus influenzae (H. influenzae)System Organ Class: 10021881 - Infections and infestations
- Registration Number
- EUCTR2006-002898-47-ES
- Lead Sponsor
- GlaxoSmithKline S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 300
All subjects:
?Subjects who 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) should be enrolled in the study.
?A male or female between, and including, 8-16 weeks (56-118 days) of age at the time of the first vaccination.
?Written informed consent obtained from the parent or guardian of the subject.
?Born after a gestation period of >27 weeks (at least 189 days).
Subjects of the Preterm I and Preterm II group:
?Medically stable* prematurely born infants, born after a gestation period of 27-36 weeks.
*Medically stable refers to the condition of premature infants who do not require significant medical support or ongoing management for debilitating disease and who have demonstrated a clinical course of sustained recovery.
Subjects of the Full term group:
?Healthy subjects as established by medical history and clinical examination before entering into the study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 300
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
?Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccines, or planned use during the study period (active phase and 5 months extended safety follow-up)
?Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs from birth to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
?Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting from one month (30 days) before the first dose of vaccines (Visit 1) and up to Visit 6.
?Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, Neisseria meningitidis and/or Streptococcus pneumoniae with the exception of vaccines where the first dose can be given within the first two weeks of life according to the national recommendations (for example hepatitis B vaccination, BGC vaccination)
?History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b disease, Neisseria meningitidis.
?History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
?History of any neurologic disorders or seizures.
?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, mild upper respiratory infection with or without temperature increase, i.e. oral/axillary/tympanic temperature <37.5°C / rectal temperature <38°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.
?Major congenital defects or serious chronic illness.
?Administration of immunoglobulins, with the exception of monoclonal antibodies against RSV, and/or any blood products within one month (30 days) preceding the first dose of study vaccines or planned administration during the active phase of the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the safety and reactogenicity of GSK Biologicals´ 10-valent pneumococcal conjugate vaccine when administered as a 3-dose primary vaccination course and co-administered with DTPa-HBV-IPV/Hib vaccine in preterm infants.;Secondary Objective: To assess the immunogenicity of GSK Biologicals´ 10-valent pneumococcal conjugate vaccine when co-administered with DTPa-HBV-IPV/Hib vaccine in preterm infants, one month post dose III vaccination.;Primary end point(s): Occurrence of core fever >39°C (rectal temperature) or >38.5°C (oral, axillary or tympanic temperature) .;Timepoint(s) of evaluation of this end point: Within 4 days (day 0-day 3) after at least one vaccination
- Secondary Outcome Measures
Name Time Method