A phase III, open, controlled study to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals’ 10- valent pneumococcal conjugate vaccine administered to children with sickle cell disease between 8 weeks and 2 years of age, as compared to healthy children. - 10PN-PD-DIT-064

GlaxoSmithKline Biologicals0 sites300 target enrollmentApril 12, 2012

ConditionsActive 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]

DrugsSynflorix

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Active immunization against disease caused by Streptococcus pneumoniae in children from 8 weeks up to 2 years of age.
Sponsor: GlaxoSmithKline Biologicals
Enrollment: 300
Status: Active, not recruiting
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 12, 2012

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

GlaxoSmithKline Biologicals

Eligibility Criteria

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.

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).