Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6-12wks of Age

GlaxoSmithKline466 enrolled

Overview

The purpose of the present study is to demonstrate that the changes in the manufacturing process for the commercial lot of the pneumococcal conjugate vaccine GSK1024850A have no clinical impact and that the immune responses are non-inferior to the immune responses induced by the clinical lot. The study will be conducted in Singapore and Malaysia.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

466

Conditions

Infections, Streptococcal

Interventions

Pneumococcal conjugate vaccine GSK1024850A (different lots)BIOLOGICAL

Intramuscular injection, 3 doses

Infanrix hexaBIOLOGICAL

Intramuscular injection, 3 doses in Malaysia and 2 doses in Singapore

Infanrix-IPV/HibBIOLOGICAL

Intramuscular injection, only for Visit 2 in Singapore

Eligibility

Sex: ALLMin age: 6 WeeksMax age: 12 WeeksHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female subjects between, and including 6-12 weeks of age at the time of the first vaccination. * Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol. * Written or oral, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. * Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study). * Born after a gestation period of \>= 36 to \<= 42 weeks. Exclusion Criteria: * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period. * Concurrently participating in another clinical study, at any time during the study period. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. * A family history of congenital or hereditary immunodeficiency. * Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination. * Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (with the exception of hepatitis B immunoglobulins at birth). * Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae (with the exception of vaccines where the first dose can be given within the first two weeks of life). * Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before each dose of vaccine and ending 7 days after Dose 1 and Dose 2 and 30 days after Dose 3. * History of, or intercurrent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, H. influenzae type b and rotavirus disease. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. * History of any neurological disorders or seizures. * Major congenital defects or serious chronic illness. * Acute disease at the time of enrolment. * Gastroenteritis within 7 days preceding the study vaccine administration. * Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract, intussusception or other medical condition determined to be serious by the investigator.

Locations (5)

GSK Investigational Site

Kuala Lumpur, Malaysia

GSK Investigational Site

Seremban, Negeri Sembilan, Malaysia

GSK Investigational Site

Singapore, Singapore

GSK Investigational Site

Singapore, Singapore

Outcomes

Primary Outcomes

Concentrations of Antibodies Against Vaccine Components of the Pneumococcal Vaccine

Concentrations are given as Geometric Mean Concentrations (GMCs) in microgram per milliliter (μg/mL). Vaccine pneumococcal serotypes assessed included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.