Immunogenicity and safety of GlaxoSmithKline Biologicals’ Infanrix™ hexa in Indian infants administered according to a 6-10-14 week schedule, when compared to a 2-4-6 month schedule.

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

Registration Number: EUCTR2012-002426-70-Outside-EU/EEA

Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 224

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 infant between, and including, 6 to 10 weeks of age at the time of the first vaccination.
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.
Born after a normal gestation period
Should have received a birth dose of hepatitis B vaccine, as evidenced by vaccination/ immunisation certificate.

Are the trial subjects under 18? yes
Number of subjects for this age range: 224
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 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 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 30 days before the administration of the first vaccine dose and ending 30 days after the last dose.
Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b diseases.
Known exposure to diphtheria, tetanus, Bordetella pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b diseases since birth.
Known immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
A family history of congenital or hereditary immunodeficiency.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Major congenital defects or serious chronic illness.
History of any neurologic disorders or seizures.
Acute disease at the time of enrolment.
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.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the antibody response to pertussis toxin (PT), filamentous haemagglutinin (FHA), pertactin (PRN) and poliovirus types 1, 2, 3 after a three-dose primary vaccination course with Infanrix hexa.;Secondary Objective: To assess the antibody response to recombinant hepatitis B surface antigen, diphtheria toxoid, tetanus toxoid and Haemophilus influenzae type b (Hib) capsular poly-saccharide polyribosyl-ribitol phosphate (PRP) after a three-dose primary vaccination course with Infanrix? hexa.<br>To evaluate the reactogenicity and safety of GSK Biologicals’ Infanrix™ hexa when administered as a three-dose primary vaccination course.<br>;Primary end point(s): Vaccine response to PT, FHA, and PRN.<br>Seroprotection against poliovirus types 1, 2, and 3, defined as anti-poliovirus neutralizing antibody titres more than or equal to 8 for all three types.;Timepoint(s) of evaluation of this end point: One month after third dose of vaccination in both the groups (Week 18/Month 7).

Secondary Outcome Measures