Immunological Persistence After Priming With GSK1024850A Vaccine and Safety& Immunogenicity After Booster Dose

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01119625
First received: April 22, 2010
Last updated: June 14, 2012
Last verified: June 2012
Results First Received: February 16, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Pneumococcal Disease
Haemophilus Influenzae Infections
Interventions: Biological: Pneumococcal vaccine GSK1024850A
Biological: Infanrix-IPV/Hib

  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
This booster study was conducted in Singapore only wheras the primary vaccination phase (NCT00808444) was conducted in Singapore and Malaysia.

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™ Clinical-Commercial + Infanrix™-IPV/Hib Group children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.

Participant Flow:   Overall Study
    Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group     Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group  
STARTED     118     120  
COMPLETED     115     116  
NOT COMPLETED     3     4  
Lost to Follow-up                 1                 2  
Withdrawal by Subject                 2                 1  
Unspecified                 0                 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™ Clinical-Commercial + Infanrix™-IPV/Hib Group children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
Total Total of all reporting groups

Baseline Measures
    Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group     Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group     Total  
Number of Participants  
[units: participants]
  118     120     238  
Age  
[units: Months]
Mean ± Standard Deviation
     
Months     18.8  ± 0.84     18.9  ± 0.87     18.9  ± 0.86  
Gender  
[units: Subjects]
     
Female     62     49     111  
Male     56     71     127  



  Outcome Measures
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1.  Primary:   Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.   [ Time Frame: Before booster vaccination at Month 0 ]

2.  Primary:   Concentrations of Antibodies Against Protein D (PD).   [ Time Frame: Before booster vaccination at Month 0 ]

3.  Secondary:   Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs).   [ Time Frame: Within 4 days (Days 0-3) after booster vaccination. ]

4.  Secondary:   Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs).   [ Time Frame: Within 4 days (Days 0-3) after booster vaccination. ]

5.  Secondary:   Number of Subjects Reporting Unsolicited Adverse Events (AEs).   [ Time Frame: Within 31 days (Days 0-30) after booster vaccination ]

6.  Secondary:   Number of Subjects Reporting Serious Adverse Events (SAEs).   [ Time Frame: During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1 ]

7.  Secondary:   Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes.   [ Time Frame: Before booster vaccination at Month 0 ]

8.  Secondary:   Concentrations of Antibodies Against Diphtheria and Tetanus.   [ Time Frame: Before booster vaccination at Month 0 ]

9.  Secondary:   Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN).   [ Time Frame: Before booster vaccination at Month 0 ]

10.  Secondary:   Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP).   [ Time Frame: Before booster vaccination at Month 0 ]

11.  Secondary:   Titers of Antibodies Against Poliovirus Types 1, 2 and 3.   [ Time Frame: Before booster vaccination at Month 0 ]

12.  Secondary:   Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.   [ Time Frame: Before and one month after booster vaccination (at Month 0 and Month 1) ]

13.  Secondary:   Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes.   [ Time Frame: Before and one month after booster vaccination (at Month 0 and Month 1) ]

14.  Secondary:   Concentrations of Antibodies Against Protein D (PD).   [ Time Frame: Before and one month after booster vaccination (at Month 0 and Month 1) ]

15.  Secondary:   Concentrations of Antibodies Against Diphtheria and Tetanus.   [ Time Frame: Before and one month after booster vaccination (at Month 0 and Month 1) ]

16.  Secondary:   Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN).   [ Time Frame: Before and one month after booster vaccination (at Month 0 and Month 1) ]

17.  Secondary:   Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP).   [ Time Frame: Before and one month after booster vaccination (at Month 0 and Month 1) ]

18.  Secondary:   Titers of Antibodies Against Poliovirus Types 1, 2 and 3.   [ Time Frame: Before and one month after booster vaccination (at Month 0 and Month 1) ]

19.  Secondary:   Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes.   [ Time Frame: Before and one month after booster vaccination (at Month 0 and Month 1) ]
Results not yet reported.   Anticipated Reporting Date:   12/2099   Safety Issue:   No

20.  Secondary:   Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A.   [ Time Frame: Before and one month after booster vaccination (at Month 0 and Month 1) ]
Results not yet reported.   Anticipated Reporting Date:   12/2099   Safety Issue:   No


  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
No text entered.


  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


No publications provided


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01119625     History of Changes
Other Study ID Numbers: 113266
Study First Received: April 22, 2010
Results First Received: February 16, 2012
Last Updated: June 14, 2012
Health Authority: Singapore: Health Sciences Authority