Primary Vaccination Course in Children Receiving Pneumococcal Conjugate Vaccine GSK 1024850A or Prevenar™ and Hiberix™

GlaxoSmithKline503 enrolled

Overview

The purposes of this study are: To demonstrate the immunogenicity in terms of antibody response following primary vaccination of Korean infants with the pneumococcal conjugate vaccine GSK 1024850A compared to Prevenar™ when co-administered with a Haemophilus influenzae type b (Hib) vaccine in children during the first 6 months of life. To evaluate the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of Korean infants with the pneumococcal conjugate vaccine GSK 1024850A.

Vaccination course at 2, 4, 6 months of age.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

503

Conditions

Infections, Streptococcal

Interventions

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 should be enrolled in the study. * Written and signed 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 inclusive, with a birth weight of at least 2.5 kilogram. 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, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). * Chronic administration of immunosuppressants or other immune-modifying drugs since birth. * Planned administration/administration of a vaccine not allowed by the study protocol during the study period. Vaccines included in the Korean routine immunization schedule can be administered at least one week before or at least one month after the administration of the study vaccines. Recommended live vaccines not included in the Korean routine immunization schedule can be given at least one month before or at least one month after the administration of the study vaccines. * 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 (Hepatitis B immunoglobulins at birth are allowed). * Previous vaccination against Streptococcus pneumoniae and/or Haemophilus influenzae type b. * History of, or intercurrent Streptococcus pneumoniae and/or Haemophilus influenzae type b 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. Study entry should be delayed until the illness has improved.

Locations (14)

GSK Investigational Site

Ansan, South Korea

GSK Investigational Site

Bucheon-si, South Korea

GSK Investigational Site

Daejeon, South Korea

GSK Investigational Site

Gyeongnam, South Korea

GSK Investigational Site

Iksan, South Korea

GSK Investigational Site

Jeju City, South Korea

GSK Investigational Site

Jeonju Jeonbuk, South Korea

GSK Investigational Site

Pusan, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Seoul, South Korea

...and 4 more locations

Outcomes

Primary Outcomes

Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value

Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (ug/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.

Time frame: One month after administration of 3rd dose of the pneumococcal conjugate vaccine

Secondary Outcomes

Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes

Seropositivity status for protein D is defined as anti protein D (anti-PD) antibody concentrations \>= 100 Enzyme-Linked Immuno Sorbent Assay (EL) units EL.U/mL. Seropositivity status for pneumococcal serotypes is defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations \>= 0.05 ug/mL.