Immunogenicity and safety of two formulations of GSK Biologicals’ pneumococcal vaccine (2830929A and 2830930A) when administered in healthy infants.

• Conditions: 3-dose primary vaccination against Streptococcus pneumoniae and Haemophilus influenzae in healthy infants between 6-12 weeks of age at the time of the first vaccination and booster vaccination at 12-15 months of age.; MedDRA version: 14.1Level: LLTClassification code 10042196Term: Streptococcus pneumoniae secondary bacterial infection of acute bronchitisSystem Organ Class: 100000004862; MedDRA version: 14.1Level: LLTClassification code 10042197Term: Streptococcus pneumoniae septicaemiaSystem Organ Class: 100000004862; MedDRA version: 14.1Level: LLTClassification code 10042195Term: Streptococcus pneumoniae pneumoniaSystem Organ Class: 100000004862; MedDRA version: 14.1Level: LLTClassification code 10042194Term: Streptococcus pneumoniae meningitisSystem Organ Class: 100000004862; MedDRA version: 14.1Level: LLTClassification code 10018954Term: Haemophilus influenzae secondary bacterial infection of acute bronchitisSystem Organ Class: 100000004862; MedDRA version: 14.1Level: LLTClassification code 10054642Term: Streptococcus pneumoniae septicemiaSystem Organ Class: 100000004862; MedDRA version: 14.1Level: LLTClassification code 10018953Term: Haemophilus influenzae meningitisSystem Organ Class: 100000004862; MedDRA version: 14.1Level: LLTClassification code 10018952Term: Haemophilus influenzae infectionSystem Organ Class: 100000004862; MedDRA version: 14.1Level: LLTClassification code 10058214Term: Septicaemia due to haemophilus influenzae (H. influenzae)System Organ Class: 100000004862

• Registration Number: EUCTR2011-005743-27-DE
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-27
• Last Update Posted: 2 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 940

Inclusion Criteria

•Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LARs) can and will comply with the requirements of the protocol.
•A male or female between, and including 6 to 12 weeks (42-90 days) of age at the time of the first vaccination. In addition, the first pneumococcal and DTPa-HBV-IPV/Hib vaccination should be given in accordance with the official national recommendations for the immunisation schedule of infants.
•Written informed consent obtained from the parents/LAR(s) of the subject.
•Healthy subjects as established by medical history and clinical examination before entering into the study.
•Born after a gestation period of at least 36 weeks.

Are the trial subjects under 18? yes
Number of subjects for this age range: 940
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 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 of immunosuppressants or other immune-modifying drugs since birth.
•Planned administration/administration of a vaccine containing diphtheria toxoid, tetanus toxoid (except MenC-TT in Spain) or CRM197 and not foreseen by the study protocol during any time of the study period, or of any other vaccines not foreseen by the protocol in the period starting from 30 days before each dose and ending 30 days after each dose of vaccine(s), with the following exceptions:
-Licensed influenza vaccines are always allowed, even if concomitantly administered with the study vaccines.
-Licensed rotavirus vaccines are allowed if administered at least 7 days before or after each dose of study of vaccines.
-Licensed MenC-TT vaccine is allowed in Spain and should be concomitantly administered with the study vaccine at around 2, 4 and 12-15 months of age.
-In case an emergency mass vaccination for an unforeseen public health threat (e.g. a pandemic) is organised by the public health authorities, outside the routine immunization program, that vaccine can be administered at any time during the study period provided it is licensed and used according to its Summary of Product Characteristics or Prescribing Information and according to the local governmental recommendations.
•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
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
•Family history of congenital or hereditary immunodeficiency.
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
•Major congenital defects or serious chronic illness, including Kawasaki’s syndrome.
•History of any neurological disorders or seizures, including conditions such as hypotensive-hyporesponsive episodes, encephalopathy and any convulsions (afebrile and febrile).
•Acute disease and/or fever at the time of enrolment.
•Administration of immunoglobulins and/or any blood products since birth or planned administration during study period.
•Previous vaccination against diphtheria, tetanus, pertussis, polio, H. influenzae type b.
•Previous vaccination against S. pneumoniae.
•History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, H. influenzae type b disease.
•Any medical condition which might interfere with the assessment of the study objectives in the opinion of the investigator.

Study & Design

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