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Immunogenicity and Safety of Booster Dose of PoliorixTM Vaccine in Previously Vaccinated Toddlers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01323647
First received: March 24, 2011
Last updated: October 13, 2016
Last verified: October 2016
Results First Received: October 13, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Poliomyelitis
Interventions: Biological: PoliorixTM
Biological: Infanrix+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
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
Poliorix Group Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
Control Group Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.

Participant Flow:   Overall Study
    Poliorix Group   Control Group
STARTED   470   487 
COMPLETED   461   487 
NOT COMPLETED   9   0 
Migrated/moved from study area                2                0 
Withdrawal by Subject                5                0 
Lost to Follow-up                2                0 



  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
Poliorix Group Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
Control Group Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.
Total Total of all reporting groups

Baseline Measures
   Poliorix Group   Control Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 470   487   957 
Age 
[Units: Months]
Mean (Standard Deviation)
 18.7  (0.93)   18.8  (1.01)   18.75  (0.97) 
Gender 
[Units: Participants]
     
Female   234   227   461 
Male   236   260   496 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value   [ Time Frame: One month after Poliorix™ booster vaccination. ]

2.  Primary:   Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value   [ Time Frame: Before booster vaccination. ]

3.  Primary:   Antibody Titres Against Poliovirus Type 1, 2 and 3   [ Time Frame: One month after Poliorix™ booster vaccination. ]

4.  Primary:   Antibody Titres Against Poliovirus Type 1, 2 and 3.   [ Time Frame: Before booster vaccination. ]

5.  Secondary:   Number of Subjects With Any and Grade 3 Solicited Local Symptoms   [ Time Frame: Within 4-days (Days 0-3) post Poliorix™ booster vaccination. ]

6.  Secondary:   Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.   [ Time Frame: Within 4-days (Days 0-3) post Poliorix™ booster vaccination. ]

7.  Secondary:   Number of Subjects Reporting Any Unsolicited Adverse Event (AE)   [ Time Frame: Within the 31-day follow-up period after the Poliorix™ booster vaccination. ]

8.  Secondary:   Number of Subjects With Serious Adverse Events (SAEs)   [ Time Frame: During the entire study period (Day 0 to Month 01). ]


  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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01323647     History of Changes
Other Study ID Numbers: 114306
Study First Received: March 24, 2011
Results First Received: October 13, 2016
Last Updated: October 13, 2016
Health Authority: China: Food and Drug Administration