We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Evaluate the Immunogenicity and Reactogenicity of a Booster Dose of GSK2036874A Vaccine in Healthy Toddlers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01106092
First Posted: April 19, 2010
Last Update Posted: May 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
Results First Submitted: March 1, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions: Haemophilus Influenzae Type b
Tetanus
Hepatitis B
Whole Cell Pertussis
Diphtheria
Interventions: Biological: GSK2036874A vaccine
Biological: Zilbrix™/Hib vaccine
Biological: Poliorix™

  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
GSK2036874A Group 1 Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
GSK2036874A Group 2 Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
GSK2036874A Group 3 Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Zilbrix/Hib/Poliorix Group Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.

Participant Flow:   Overall Study
    GSK2036874A Group 1   GSK2036874A Group 2   GSK2036874A Group 3   Zilbrix/Hib/Poliorix Group
STARTED   78   78   78   78 
COMPLETED   78   78   78   77 
NOT COMPLETED   0   0   0   1 
Withdrawal by Subject                0                0                0                1 



  Baseline Characteristics
  Hide Baseline Characteristics

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
GSK2036874A Group 1 Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
GSK2036874A Group 2 Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
GSK2036874A Group 3 Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Zilbrix/Hib/Poliorix Group Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Total Total of all reporting groups

Baseline Measures
   GSK2036874A Group 1   GSK2036874A Group 2   GSK2036874A Group 3   Zilbrix/Hib/Poliorix Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 78   78   78   78   312 
Age 
[Units: Months]
Mean (Standard Deviation)
 17.4  (3.81)   18  (2.96)   17.7  (3.38)   17.5  (3.59)   17.65  (3.44) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      37  47.4%      31  39.7%      35  44.9%      40  51.3%      143  45.8% 
Male      41  52.6%      47  60.3%      43  55.1%      38  48.7%      169  54.2% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
         
Asian-South East Asian heritage   78   78   78   78   312 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3   [ Time Frame: One month after booster vaccination (At Month 1) ]

2.  Primary:   Anti-polio Types 1, 2 and 3   [ Time Frame: Prior to booster vaccination (At Month 0) ]

3.  Primary:   Anti-polio Types 1, 2 and 3   [ Time Frame: One month after booster vaccination (At Month 1) ]

4.  Secondary:   Number of Seroconverted Subjects for Anti-polio Types 1, 2 and 3   [ Time Frame: One month after booster vaccination (At Month 1) ]

5.  Secondary:   Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3   [ Time Frame: Prior to booster vaccination (At Month 0) ]

6.  Secondary:   Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T)   [ Time Frame: Prior to (At Month 0) and one month after booster vaccination (At Month 1) ]

7.  Secondary:   Anti-D and Anti-T Antibody Concentrations   [ Time Frame: Prior to (At Month 0) and one month after booster vaccination (At Month 1) ]

8.  Secondary:   Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B (Anti-HBs)   [ Time Frame: Prior to (At Month 0) and one month after the booster vaccination (At Month 1) ]

9.  Secondary:   Anti-HBs Antibody Concentrations   [ Time Frame: Prior to (At Month 0) and one month after the booster vaccination (At Month 1) ]

10.  Secondary:   Number of Seroprotected Subjects Against Polyribosil-ribitol-phosphate (PRP)   [ Time Frame: Prior to (At Month 0) and one month after booster vaccination (At Month 1) ]

11.  Secondary:   Anti-PRP Antibody Concentrations   [ Time Frame: Prior to (At Month 0) and one month after booster vaccination (At Month 1) ]

12.  Secondary:   Number of Seropositive Subjects for Anti-Bordetella Pertussis (Anti-BPT)   [ Time Frame: Prior to (At Month 0) and one month after the booster vaccination (At Month 1) ]

13.  Secondary:   Anti-BPT Antibody Concentrations   [ Time Frame: Prior to (At Month 0) and one month after booster vaccination (At Month 1) ]

14.  Secondary:   Number of Subjects With a Booster Response for Anti-BPT   [ Time Frame: One month after booster vaccination (At Month 1) ]

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

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

17.  Secondary:   Number of Subjects With Any Unsolicited Adverse Events (AEs)   [ Time Frame: During the 31-day (Day 0-Day 30) post-vaccination period ]

18.  Secondary:   Number of Subjects With Serious Adverse Events (SAEs)   [ Time Frame: During the entire study period (from Month 0 to Month 1) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
  Hide More Information

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: NCT01106092     History of Changes
Other Study ID Numbers: 113264
First Submitted: April 1, 2010
First Posted: April 19, 2010
Results First Submitted: March 1, 2017
Results First Posted: April 12, 2017
Last Update Posted: May 17, 2017