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

Study Overview
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Brief Summary
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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.

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

Official Title
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Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A or Prevenar™ Co-administered With Hiberix™

Conditions
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Infections, Streptococcal

Intervention / Treatment
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* Biological: Pneumococcal vaccine GSK1024850A (Synflorix)
* Biological: Prevenar
* Biological: GSK Biologicals' Hiberix™


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Weeks
Maximum Age: 12 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Synflorix Group<br>Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4. | Biological: Pneumococcal vaccine GSK1024850A (Synflorix)<br>* 3 doses administered intramuscularly.<br>Biological: GSK Biologicals' Hiberix™<br>* 3 doses administered intramuscularly.<br>* Other names: Hib;|
| Active Comparator: Prevenar Group<br>Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4. | Biological: Prevenar<br>* 3 doses administered intramuscularly.<br>Biological: GSK Biologicals' Hiberix™<br>* 3 doses administered intramuscularly.<br>* Other names: Hib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | One month after administration of 3rd dose of the pneumococcal conjugate vaccine | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine | 
| Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value | The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. In this assay the cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was >= 8. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. | One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine | 
| Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value | Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (ug/mL). Pneumococcal cross-reactive serotypes were 6A and 19A. | One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine | 
| Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine | Concentrations are reported as Geometric Mean Concentrations in ug/mL. Pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F. | One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine | 
| Anti-PD Antibody Concentration | Concentration of anti-PD antibody given as GMC expressed in EL.U/mL. | One month after administration of 3rd vaccine dose of the pneumococcal conjugate vaccine | 
| Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes | Concentration of cross-reactive pneumococcal serotypes 6A and 19A in ug/mL. | One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine | 
| Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes | The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. In this assay the cut-off value for opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A was defined as >= 8. | One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine | 
| Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations | Concentration of anti-PRP antibody given as GMC in ug/mL. | One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine | 
| Number of Subjects With Seroprotection Status Against PRP | Seroprotection status is defined as anti-PRP antibody concentrations above 0.15 ug/mL and above 1.0 ug/mL | One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine | 
| Number of Subjects Reporting Solicited Local Symptoms | Solicited local symptoms assessed include pain, redness and swelling. | Within 4 days after each vaccination | 
| Number of Subjects With Solicited General Symptoms | Solicited general symptoms assessed include drowsiness, fever, irritability and loss of appetite. Fever was defined as axillary temperature >= 37.5 degrees Celsius. | Within 4 days after each vaccination | 
| Number of Subjects Reporting Unsolicited Adverse Events |  | Within 31 days after each vaccination | 
| Number of Subjects With Serious Adverse Events (SAE) | An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. | Following the administration of the first dose of the study vaccines throughout the entire study period up to study month 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Streptococcus pneumoniae, pneumococcal conjugate vaccine