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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00680914
• Date of registration: 16/05/2008
• Primary sponsor: GlaxoSmithKline
• Public title: Primary Vaccination Course in Children Receiving Pneumococcal Conjugate Vaccine GSK 1024850A or Prevenar™ and Hiberix™
• Scientific title: Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A or Prevenar™ Co-administered With Hiberix™
• Date of first enrolment: June 2008
• Target sample size: 503
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00680914
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Countries of recruitment

Korea, Republic of

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

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.



Age minimum: 6 Weeks
Age maximum: 12 Weeks
Gender: Both

Health Condition(s) or Problem(s) studied

Pneumococcal Disease

Streptococcus Pneumoniae Vaccines

Intervention(s)

Biological: GSK Biologicals' Hiberix™

Biological: Pneumococcal vaccine GSK1024850A (Synflorix)

Biological: Prevenar

Primary Outcome(s)

Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value [Time Frame: One month after administration of 3rd dose of the pneumococcal conjugate vaccine]

Secondary Outcome(s)

Anti-PD Antibody Concentration [Time Frame: One month after administration of 3rd vaccine dose of the pneumococcal conjugate vaccine]

Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations [Time Frame: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine]

Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine [Time Frame: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine]

Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes [Time Frame: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine]

Number of Subjects Reporting Solicited Local Symptoms [Time Frame: Within 4 days after each vaccination]

Number of Subjects Reporting Unsolicited Adverse Events [Time Frame: Within 31 days after each vaccination]

Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes [Time Frame: 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 [Time Frame: 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 [Time Frame: 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 [Time Frame: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine]

Number of Subjects With Serious Adverse Events (SAE) [Time Frame: Following the administration of the first dose of the study vaccines throughout the entire study period up to study month 5]

Number of Subjects With Seroprotection Status Against PRP [Time Frame: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine]

Number of Subjects With Solicited General Symptoms [Time Frame: Within 4 days after each vaccination]

Secondary ID(s)

110808

Source(s) of Monetary Support

Please refer to primary and secondary sponsors