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Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 8 Weeks of Age

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00533507
First received: September 20, 2007
Last updated: October 27, 2016
Last verified: October 2016
Results First Received: June 5, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Infections, Rotavirus
Interventions: Biological: Synflorix
Biological: Infanrix hexa
Biological: Rotarix

  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 receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.

Participant Flow:   Overall Study
    Synflorix Group
STARTED   230 
COMPLETED   229 
NOT COMPLETED   1 
Withdrawal by Subject                1 



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Synflorix Group Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.

Baseline Measures
   Synflorix Group 
Overall Participants Analyzed 
[Units: Participants]
 230 
Age 
[Units: Weeks]
Mean (Standard Deviation)
 6.4  (0.60) 
Gender 
[Units: Participants]
Count of Participants
 
Female      115  50.0% 
Male      115  50.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Concentration of Anti-Protein D Antibodies   [ Time Frame: One month after the third dose ]

2.  Primary:   Concentration of Anti-Pneumococcal Antibodies   [ Time Frame: One month after the third dose ]

3.  Secondary:   Number of Subjects With Anti-Protein D Antibody Concentrations Above the Cut-Off Value   [ Time Frame: Before the first dose (pre) and one month after (post) the third dose ]

4.  Secondary:   Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value   [ Time Frame: Before the first dose (pre) and one month after (post) the third dose ]

5.  Secondary:   Number of Subjects With Cross-Reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value   [ Time Frame: One month after the third dose ]

6.  Secondary:   Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-Off Value   [ Time Frame: One month after the third dose ]

7.  Secondary:   Number of Subjects With Opsonophagocytic Activity Against Cross-Reactive Pneumococcal Serotypes Above the Cut-Off Value   [ Time Frame: One month after the third dose ]

8.  Secondary:   Number of Subjects With Anti-Polyribosyl-Ribitol Phosphate Antibody Concentrations Above the Cut-Off Value   [ Time Frame: One month after the third dose ]

9.  Secondary:   Number of Subjects With Anti-Diphteria and Anti-Tetanus Toxoids Antibody Concentrations Above the Cut-Off Value   [ Time Frame: One month after the third dose ]

10.  Secondary:   Number of Subjects With Anti-Pertussis (PT), Anti-Filamentous Hemagglutinin (FHA) and Anti-Pertactin (PRN) Antibody Concentrations Above the Cut-Off Value   [ Time Frame: One month after the third dose ]

11.  Secondary:   Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value   [ Time Frame: One month after the third dose ]

12.  Secondary:   Number of Subjects With Anti-Poliovirus 1, 2 and 3 Antibody Titers Above the Cut-Off Value   [ Time Frame: One month after the third dose ]

13.  Secondary:   Number of Subjects With Anti-rotavirus Immunoglobulin A Antibody Concentrations Above the Cut-Off Value   [ Time Frame: Four months after the administration of the second dose of Rotarix™ vaccine ]

14.  Secondary:   Number of Subjects Reporting Solicited Symptoms   [ Time Frame: During the 4-day (Day 0-3) period after each dose ]

15.  Secondary:   Number of Subjects Reporting Unsolicited Adverse Events (AE)   [ Time Frame: During the 31-day (Day 0-30) period after each dose ]

16.  Secondary:   Number of Subjects Reporting Serious Adverse Events (SAE)   [ Time Frame: Up to one month after the third dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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.


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


Publications:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00533507     History of Changes
Other Study ID Numbers: 109861
Study First Received: September 20, 2007
Results First Received: June 5, 2009
Last Updated: October 27, 2016