Immunization of Children Between 8 Weeks and 2 Years of Age With a pneumococcal conjugate vaccine

• Conditions: Active immunization against disease caused by Streptococcus pneumoniae in children from 8 weeks up to 2 years of age.; MedDRA version: 17.1Level: PTClassification code 10061190Term: Haemophilus infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 17.1Level: PTClassification code 10061353Term: Pneumococcal infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2012-000254-64-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-12
• Last Update Posted: 23 March 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

•Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol
•A male or female between, and including: 8 and 11 weeks of age at the time of the first vaccination for subjects in the <6S and <6NS groups or 7 and 11 months at the time of the first vaccination for subjects in the 7-11S and 7-11NS groups or 12 and 23 months at the time of first vaccination for subjects in the 12-23S and 12-23NS groups (Note the second dose should be administered at 23 Months of age at the latest to allow, if needed, compliance with the National Recommendations on administration of the 23-valent polysaccharide pneumococcal vaccine in children with SCD as of 24 months of age).
•Written informed consent, signed or thumb printed, obtained from the parent(s)/LAR(s) of the subject. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by a witness.
Additional inclusion criteria for children with SCD (<6S, 7-11S and 12-23S groups):
•Children with neonatal diagnosis of sickle cell disease [homozygous sickle cell disease (hemoglobin SS disease), double heterozygous sickle hemoglobin C disease (hemoglobin SC disease) and the sickle ß-thalassemias] and confirmed haemoglobin status by haemoglobin chromatography and electrophoresis(<6S group) or electrophoresis (7-11S and 12-23S groups).
•Free of any other known or suspected health problems (as established by medical history and clinical examination before entering into the study), that would contraindicate the initiation of routine immunizations outside a clinical trial context
Additional inclusion criteria for healthy children (<6NS, 7-11NS and
12-23NS groups):
•Healthy subjects as established by medical history and clinical examination before entering into the study.
•Children with negative neonatal diagnosis of sickle cell disease and confirmed hemoglobin status by hemoglobin chromatography and/or electrophoresis.
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

Exclusion Criteria

•Child in care
•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
•Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone equal or more than 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
•Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccines and ending 30 days after. Locally recommended vaccines (recommended through the EPI program or through national immunization campaigns) for example inactivated influenza vaccine are always allowed with the exception of DTP-HBV/Hib in the <6S group and <6NS group, even if concomitantly administered with the study vaccines, but should be documented in the eCRF.
•Subjects being heterozygous or carriers of abnormal haemoglobin (e.g. haemoglobin S, Haemoglobin C) who are not considered to have SCD.
Additional exclusion criteria for children of the <6S and <6NS group:
•Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae type b.
•Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
•Previous vaccination or planned vaccination during the study with any pneumococcal vaccine.
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
•Major congenital malformations.
•History of any neurological disorders or seizures.
•Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
•Birth weight below 1500g.
•Serious chronic illness other than SCD.
•Acute disease and/or fever at the time of enrolment:
Fever is defined as temperature = 37.5°C on oral, axillary or tympanic setting, or = 38.0°C on rectal setting. The preferred route for recording temperature in this study will be tympanic. Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
Additional exclusion criteria for children with SCD (<6S, 7-11S and 12-23S groups):
•Any confirmed or suspected immunosuppressive or immunodeficient condition, (including human immunodeficiency virus (HIV) infection) other than SCD related conditions, based on medical history and physical examination (no laboratory testing required).
Additional exclusion criteria for healthy children (<6 NS, 7-11NS and
12-23NS groups):
•Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing required).

Study & Design

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