Immunogenicity and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ DTPa-HBV-IPV/Hib vaccine’s new formulation as com-pared with DTPa-HBV-IPV/Hib vaccine’s current formulation when administered in healthy infants at 3, 4 and 5 months of age.

• Conditions: Primary immunization of healthy infants in the first year of life against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis diseases and, if applicable, Haemophilus influenzae type b disease.; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2012-002427-15-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-01
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 417

Inclusion Criteria

Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
A male or female between, and including, 11 and 17 weeks of age at the time of the first vaccination.
Infant born to known hepatitis B surface antigen seronegative mother.
Born after a normal gestation period.
Written informed consent obtained from the parent or guardian of the subject.
Free of obvious health problems 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: 417
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

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 within six months prior to the first vaccine dose.
Any chronic drug therapy to be continued during the study period.
Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after the last vaccine dose.
Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Haemophilus influenzae diseases.
Known history of or exposure to diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Haemophilus influenzae diseases since birth.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
Any confirmed or suspected immunosuppressive or im-munodeficient condition, based on medical history and physical examination.
A family history of congenital or hereditary immunodefi-ciency.
Major congenital defects or serious chronic illness.
History of any neurologic disorders or seizures.
Acute or chronic, clinically significant pulmonary, cardio-vascular, hepatic or renal functional abnormality, as determined by physical examination.
Hepatomegaly, right upper quadrant abdominal pain or tenderness.
Acute disease at the time of enrolment.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.

Study & Design

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