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Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01090453
First received: March 18, 2010
Last updated: July 24, 2014
Last verified: June 2014
Results First Received: June 19, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Tetanus
Hepatitis B
Haemophilus Influenzae Type b
Poliomyelitis
Acellular Pertussis
Diphtheria
Neisseria Meningitidis
Interventions: Biological: GSK2202083A vaccine
Biological: Prevenar 13®
Biological: Infanrix hexa™
Biological: Menjugate®
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
A total of 480 subjects were enrolled in the study.

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
GSK2202083A Group Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
Infanrix Hexa Group Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.

Participant Flow:   Overall Study
    GSK2202083A Group     Infanrix Hexa Group  
STARTED     238     242  
COMPLETED     225     228  
NOT COMPLETED     13     14  
Withdrawal by Subject                 1                 2  
Lost to Follow-up                 7                 7  
Non serious AEs                 1                 0  
Protocol Violation                 2                 0  
Unspecified                 2                 4  
Eligibility Criteria                 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
GSK2202083A Group Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
Infanrix Hexa Group Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
Total Total of all reporting groups

Baseline Measures
    GSK2202083A Group     Infanrix Hexa Group     Total  
Number of Participants  
[units: participants]
  238     242     480  
Age  
[units: Weeks]
Mean ± Standard Deviation
  9.10  ± 1.15     9.20  ± 1.17     9.15  ± 1.16  
Gender  
[units: Subjects]
     
Female     108     111     219  
Male     130     131     261  



  Outcome Measures
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1.  Primary:   Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Above the Cut-offs.   [ Time Frame: At Month 3, Month 10 and Month 11. ]

2.  Primary:   Number of Subjects With Neisseria Meningitidis Using Baby Rabbit Complement (rSBA-MenC) Antibodies Above the Cut-offs.   [ Time Frame: At Month 3, Month 10 and Month 11. ]

3.  Secondary:   Concentrations for Anti-PRP.   [ Time Frame: At Month 3, Month 10 and Month 11. ]

4.  Secondary:   Titers for rSBA-MenC.   [ Time Frame: At Month 3, Month 10 and Month 11. ]

5.  Secondary:   Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Above the Cut-off.   [ Time Frame: At Month 3, Month 10 and Month 11. ]

6.  Secondary:   Concentrations for Anti-T and Anti-D.   [ Time Frame: At Month 3, Month 10 and Month 11. ]

7.  Secondary:   Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL)   [ Time Frame: At Month 3, Month 10 and Month 11. ]

8.  Secondary:   Concentrations for Anti-HBs.   [ Time Frame: At Month 3, Month 10 and Month 11. ]

9.  Secondary:   Number of Subjects With Anti-poliovirus (Anti-polio) Types 1, 2 and 3 Above the Cut-off.   [ Time Frame: At Month 3, Month 10 and Month 11. ]

10.  Secondary:   Titers for Anti-polio 1, 2 and 3.   [ Time Frame: At Month 3, Month 10 and Month 11. ]

11.  Secondary:   Number Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Above the Cut-off.   [ Time Frame: At Month 3, Month 10 and Month 11. ]

12.  Secondary:   Concentrations for Anti-PT, Anti-FHA and Anti-PRN.   [ Time Frame: At Month 3, Month 10 and Month 11. ]

13.  Secondary:   Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN.   [ Time Frame: At Month 11. ]

14.  Secondary:   Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs.   [ Time Frame: At Month 3 and Month 11 ]

15.  Secondary:   Concentrations for Anti-PNE Serotypes.   [ Time Frame: At Month 3 and Month 11 ]

16.  Secondary:   Anti-PRP and rSBA-MenC Fold Increase Distribution.   [ Time Frame: At Month 11. ]

17.  Secondary:   Number of Subjects Reporting Any Solicited Local Symptoms.   [ Time Frame: During the 8-day (Days 0-7) post-vaccination period ]

18.  Secondary:   Number of Subjects Reporting Any Solicited General Symptoms.   [ Time Frame: During the 8-day (Days 0-7) post-vaccination period ]

19.  Secondary:   Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).   [ Time Frame: Within the 31-day (Days 0-30) follow up period after vaccination ]

20.  Secondary:   Number of Subjects Reporting Any Serious Adverse Events (SAEs).   [ Time Frame: During the entire study period (Month 0 to Month 11) ]


  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: NCT01090453     History of Changes
Other Study ID Numbers: 113615
Study First Received: March 18, 2010
Results First Received: June 19, 2014
Last Updated: July 24, 2014
Health Authority: Canada: Biologics and Genetic Therapies Directorate (BGTD)
France: Agence Française de Sécurité Sanitaire des Produits de Santé
Germany: Paul-Ehrlich-Institut