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Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 10 Weeks of Age

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00814710
First received: December 23, 2008
Last updated: June 14, 2012
Last verified: June 2012
History of Changes
Results First Received: October 21, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Prevention
Conditions: Streptococcus Pneumoniae
Pneumococcal Disease
Interventions: Biological: Pneumococcal conjugate vaccine GSK1024850A
Biological: Tritanrix-HepB/Hib
Biological: Hiberix
Biological: Tritanrix-HepB

  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 and Tritanrix-HepB/Hib Group Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
Hiberix Group and Tritanrix-HepB Group Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)

Participant Flow:   Overall Study
    Synflorix and Tritanrix-HepB/Hib Group     Hiberix Group and Tritanrix-HepB Group  
STARTED     240     120  
COMPLETED     232     117  
NOT COMPLETED     8     3  
Adverse Event                 1                 0  
Lost to Follow-up                 7                 3  



  Baseline Characteristics
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Reporting Groups
  Description
Synflorix and Tritanrix-HepB/Hib Group Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
Hiberix Group and Tritanrix-HepB Group Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
Total Total of all reporting groups

Baseline Measures
    Synflorix and Tritanrix-HepB/Hib Group     Hiberix Group and Tritanrix-HepB Group     Total  
Number of Participants  
[units: participants]
 		  240     120     360  
Age  
[units: Weeks]
Mean ± Standard Deviation 		  6.7  ± 1.08     6.7  ± 1.05     6.7  ± 1.07  
Gender  
[units: Participants]
 		     
Female     109     66     175  
Male     131     54     185  



  Outcome Measures
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1.  Primary:   Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes   [ Time Frame: One month after primary immunization (month 3) ]
  Show Outcome Measure 1

2.  Primary:   Concentration of Antibody Against Protein D (PD)   [ Time Frame: One month after primary immunization (month 3) ]
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3.  Secondary:   Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes   [ Time Frame: One month after primary immunization (month 3) ]
  Show Outcome Measure 3

4.  Secondary:   Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes Equal to or Above Cut-off Value   [ Time Frame: One month after primary immunization ]
  Show Outcome Measure 4

5.  Secondary:   Concentrations of Antibodies Against Pneumococcal Cross-reactive Serotypes   [ Time Frame: One month after primary immunization (month 3) ]
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6.  Secondary:   Number of Subjects Seropositive for Pneumococcal Serotypes   [ Time Frame: One month after primary immunization (month 3) ]
  Show Outcome Measure 6

7.  Secondary:   Number of Subjects Seropositive for Protein D (PD)   [ Time Frame: One month after primary immunization (month 3) ]
  Show Outcome Measure 7

8.  Secondary:   Concentration of Antibody Against Polyribosyl-ribitol Phosphate (PRP)   [ Time Frame: One month after primary immunization (month 3) ]
  Show Outcome Measure 8

9.  Secondary:   Concentration of Antibodies Against Diphteria (Anti-DT) and Tetanus (Anti-TT)   [ Time Frame: One month after primary immunization (month 3) ]
  Show Outcome Measure 9

10.  Secondary:   Concentration of Antibody Against Bordetella Pertussis (B. Pertussis)   [ Time Frame: One month after primary immunization (month 3) ]
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11.  Secondary:   Concentration of Antibody Against Hepatitis B (Anti-HBs)   [ Time Frame: One month after primary immunization (month 3) ]
  Show Outcome Measure 11

12.  Secondary:   Number of Subjects Seropostive for B. Pertussis   [ Time Frame: One month after primary immunization (month 3) ]
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13.  Secondary:   Number of Seroprotected Subjects (Anti-DT, Anti-TT, Anti-PRP, Anti-HBs)   [ Time Frame: One month after primary immunization (month 3) ]
  Show Outcome Measure 13

14.  Secondary:   Number of Seroprotected Subjects (Anti-PRP Above the Cut-off of 1.0 µg/mL)   [ Time Frame: One month after primary immunization (month 3) ]
  Show Outcome Measure 14

15.  Secondary:   Number of Subjects With Solicited Local and General Symptoms   [ Time Frame: Within 4 days (day 0-3) after vaccination ]
  Show Outcome Measure 15

16.  Secondary:   Number of Subjects With Unsolicited Adverse Events (AEs)   [ Time Frame: Within 31 days (day 0-30) after vaccination ]
  Show Outcome Measure 16

17.  Secondary:   Number of Subjects With Serious Adverse Events (SAEs)   [ Time Frame: Following first vaccination (Month 0) throughout the entire study period (month 3) ]
  Show Outcome Measure 17


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


No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00814710     History of Changes
Other Study ID Numbers: 111188
Study First Received: December 23, 2008
Results First Received: October 21, 2010
Last Updated: June 14, 2012
Health Authority: India: Ministry of Health