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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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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
  Show All Outcome Measures

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 ]
  Show Outcome Measure 4

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 ]
  Show Outcome Measure 5

6.  Secondary:   Anti-PD Antibody Concentration   [ Time Frame: One month after administration of 3rd vaccine dose of the pneumococcal conjugate vaccine ]
  Hide Outcome Measure 6

Measure Type Secondary
Measure Title Anti-PD Antibody Concentration
Measure Description Concentration of anti-PD antibody given as GMC expressed in EL.U/mL.
Time Frame One month after administration of 3rd vaccine dose of the pneumococcal conjugate vaccine  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.

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

Measured Values
    Synflorix Group     Prevenar Group  
Number of Participants Analyzed  
[units: participants]
 		  344     123  
Anti-PD Antibody Concentration  
[units: EL.U/mL]
Geometric Mean ( 95% Confidence Interval ) 		  1622.4  
  ( 1500.8 to 1754.0 )   		  88.2  
  ( 74.7 to 104.0 )  

No statistical analysis provided for Anti-PD Antibody Concentration



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 ]
  Show Outcome Measure 10

11.  Secondary:   Number of Subjects Reporting Solicited Local Symptoms   [ Time Frame: Within 4 days after each vaccination ]
  Show Outcome Measure 11

12.  Secondary:   Number of Subjects With Solicited General Symptoms   [ Time Frame: Within 4 days after each vaccination ]
  Show Outcome Measure 12

13.  Secondary:   Number of Subjects Reporting Unsolicited Adverse Events   [ Time Frame: Within 31 days after each vaccination ]
  Show Outcome Measure 13

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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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications:
Schuerman L et al. Population variability of opsonophagocytic activity following 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate (PHiD-CV) vaccination more limited than antibody responses. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
Kim KH et al. Immunogenicity of primary vaccination with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Korean infants. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
Kim JS et al. Safety and reactogenicity of primary vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Korean infants. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
Schuerman L et al. Population variability in antibody responses following pneumococcal conjugate vaccination: experience with the non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.

Publications automatically indexed to this study:


Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00680914     History of Changes
Other Study ID Numbers: 110808
Study First Received: May 16, 2008
Results First Received: May 13, 2010
Last Updated: January 12, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)