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Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Poliorix™ Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01021293
First received: November 25, 2009
Last updated: April 19, 2017
Last verified: March 2017
Results First Received: March 6, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Prevention
Condition: Poliomyelitis
Interventions: Biological: Poliorix™
Biological: Oral Poliovirus vaccine

  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
Of the 1101 enrolled subjects, one subject was not randomised and administered any vaccine as the parents of the subject refused to vaccinate their child after blood collection at Visit 1 and withdrew their consent.

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 Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix™ (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
Control Group Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.

Participant Flow:   Overall Study
    Poliorix Group   Control Group
STARTED   550   550 
COMPLETED   538   526 
NOT COMPLETED   12   24 
Serious Adverse Event                2                1 
Adverse Event                2                1 
Withdrawal by Subject                1                3 
Migrated/moved from study area                6                18 
Lost to Follow-up                1                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
Poliorix Group Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix™ (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
Control Group Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
Total Total of all reporting groups

Baseline Measures
   Poliorix Group   Control Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 550   550   1100 
Age 
[Units: Weeks]
Mean (Standard Deviation)
 10  (1.16)   10.1  (1.18)   10.05  (1.17) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      268  48.7%      259  47.1%      527  47.9% 
Male      282  51.3%      291  52.9%      573  52.1% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Asian-Chinese heritage   550   550   1100 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3   [ Time Frame: At Month 3, one month after the third vaccine dose ]

2.  Secondary:   Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3   [ Time Frame: At Day 0, prior to the first vaccine dose ]

3.  Secondary:   Anti-poliovirus Types 1, 2 and 3 Antibody Titers   [ Time Frame: Prior to the first vaccine dose (Day 0) and one month after the third vaccine dose (Month 3) ]

4.  Secondary:   Number of Subjects With Any and Grade 3 Solicited Local Symptoms   [ Time Frame: During the 4-day (Days 0–3) post-vaccination period following each vaccine dose and across doses ]

5.  Secondary:   Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms   [ Time Frame: During the 4-day (Days 0–3) post-vaccination period following each vaccine dose and across doses ]

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

7.  Secondary:   Number of Subjects With Serious Adverse Events (SAEs)   [ Time Frame: During the entire study period (from Day 0 to Month 3) ]


  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


Publications:
Li R et al. Immunogenicity and safety of an inactivated poliovirus vaccine in Chinese infants. Abstract presented at the 7th World Congress for World Society for Pediatric Infectious Diseases (WSPID). The Melbourne, The Australia, 16-19 November 2011.

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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01021293     History of Changes
Other Study ID Numbers: 112679
Study First Received: November 25, 2009
Results First Received: March 6, 2017
Last Updated: April 19, 2017