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Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 3, 5 and 11 Months of Age.

This study has been terminated.
(Study stopped due to non-approval of IEC to proposed change in locations. Study discontinuation not due to safety/efficacy reasons related to the vaccine.)
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00871741
First received: March 26, 2009
Last updated: April 5, 2017
Last verified: April 2017
Results First Received: February 16, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Prevention
Conditions: Tetanus
Poliomyelitis
Neisseria Meningitidis
Haemophilus Influenzae Type b
Diphtheria
Acellular Pertussis
Hepatitis B
Interventions: Biological: GSK2202083A vaccine
Biological: Infanrix hexa
Biological: Menjugate

  Participant Flow
  Hide Participant Flow

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
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

Reporting Groups
  Description
GSK2202083A Group Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
Infanrix + Menjugate Group Subjects in this group were to receive three doses of Infanrix™ hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate® vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.

Participant Flow:   Overall Study
    GSK2202083A Group   Infanrix + Menjugate Group
STARTED   9   7 
COMPLETED   0   0 
NOT COMPLETED   9   7 
Premature study termination                9                7 



  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 in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
Infanrix + Menjugate Group Subjects in this group were to receive three doses of Infanrix™ hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate® vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
Total Total of all reporting groups

Baseline Measures
   GSK2202083A Group   Infanrix + Menjugate Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 9   7   16 
Age 
[Units: Weeks]
Mean (Standard Deviation)
     
Weeks   12.8  (2.28)   13.9  (1.57)   13.28  (2.02) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      2  22.2%      5  71.4%      7  43.8% 
Male      7  77.8%      2  28.6%      9  56.3% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
White-Caucasian/European   9   7   16 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Anti-PRP Antibody Concentrations ≥ 0.15 mg/mL   [ Time Frame: At Month 3 ]

2.  Secondary:   Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms   [ Time Frame: During the 8-day (Days 0-7) post-vaccination period following each dose and across doses ]

3.  Secondary:   Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms   [ Time Frame: During the 8-day (Days 0-7) post-vaccination period following each dose and across doses ]

4.  Secondary:   Number of Subjects With Unsolicited Adverse Events AE(s)   [ Time Frame: During the 31-day (Days 0-30) post-vaccination period ]

5.  Secondary:   Number of Subjects With Serious Adverse Events (SAEs)   [ Time Frame: During the entire study period (from Month 0 to Month 9) ]


  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



Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00871741     History of Changes
Other Study ID Numbers: 111761
Study First Received: March 26, 2009
Results First Received: February 16, 2017
Last Updated: April 5, 2017