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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00680914
First received: May 16, 2008
Last updated: January 12, 2012
Last verified: March 2011
History of Changes
Results First Received: May 13, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Prevention
Conditions: Pneumococcal Disease
Streptococcus Pneumoniae Vaccines
Interventions: Biological: Pneumococcal vaccine GSK1024850A (Synflorix)
Biological: Prevenar
Biological: GSK Biologicals' Hiberix™

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Synflorix Group Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
Prevenar Group Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4

Participant Flow:   Overall Study
    Synflorix Group     Prevenar Group  
STARTED     374     129  
COMPLETED     364     125  
NOT COMPLETED     10     4  
Consent withdrawal                 6                 3  
Lost to Follow-up                 4                 0  
serious adverse event (SAE)                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Synflorix Group Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
Prevenar Group Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4
Total Total of all reporting groups

Baseline Measures
    Synflorix Group     Prevenar Group     Total  
Number of Participants  
[units: participants]
 		  374     129     503  
Age  
[units: years]
Mean ± Standard Deviation 		  9.5  ± 1.49     9.5  ± 1.43     9.5  ± 1.47  
Gender  
[units: participants]
 		     
Female     189     71     260  
Male     185     58     243  
Region of Enrollment  
[units: participants]
 		     
East Asia     373     129     502  
Southeast Asia     1     0     1  



  Outcome Measures
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1.  Primary:   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 ]
  Show Outcome Measure 1

2.  Secondary:   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 ]
  Show Outcome Measure 2

3.  Secondary:   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 ]
  Show Outcome Measure 3

4.  Secondary:   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 ]
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5.  Secondary:   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 ]
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6.  Secondary:   Anti-PD Antibody Concentration   [ Time Frame: One month after administration of 3rd vaccine dose of the pneumococcal conjugate vaccine ]
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7.  Secondary:   Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes   [ Time Frame: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine ]
  Show Outcome Measure 7

8.  Secondary:   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 ]
  Show Outcome Measure 8

9.  Secondary:   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 ]
  Show Outcome Measure 9

10.  Secondary:   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 ]
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11.  Secondary:   Number of Subjects Reporting Solicited Local Symptoms   [ Time Frame: Within 4 days after each vaccination ]
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12.  Secondary:   Number of Subjects With Solicited General Symptoms   [ Time Frame: Within 4 days after each vaccination ]
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13.  Secondary:   Number of Subjects Reporting Unsolicited Adverse Events   [ Time Frame: Within 31 days after each vaccination ]
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14.  Secondary:   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 ]
  Show Outcome Measure 14


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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