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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:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00533507
First received: September 20, 2007
Last updated: January 5, 2012
Last verified: February 2011
Results First Received: June 5, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Pneumococcal Disease
Streptococcus Pneumoniae Vaccines
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
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 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.
No text entered.

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  
Number of Participants  
[units: participants]
  230  
Age  
[units: weeks]
Mean ± Standard Deviation
  6.4  ± 0.60  
Gender  
[units: subjects]
 
Female     115  
Male     115  



  Outcome Measures
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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:
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.
Bermal N et al. Immunogenicity of a 10 valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) co-administered with routine paediatric vaccines in Asian infants. Abstract presented at the 3rd Vaccine Congress. Singapore, Singapore, 4-6 October 2009.
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.

Publications automatically indexed to this study:

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
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: January 5, 2012
Health Authority: Taiwan: Department of Health