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Immunogenicity and Safety of GSK Biologicals' Boostrix Polio Vaccine in 3 and 4-year-old Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01245049
First Posted: November 22, 2010
Last Update Posted: July 5, 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: February 24, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: Acellular Pertussis
Poliomyelitis
Tetanus
Diphtheria
Interventions: Biological: Boostrix PolioTM
Biological: RepevaxTM
Biological: PriorixTM

  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
2 subjects did not receive vaccination.

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
Boostrix Polio Group Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
Repevax Group Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.

Participant Flow:   Overall Study
    Boostrix Polio Group   Repevax Group
STARTED   255   130 
COMPLETED   254   126 
NOT COMPLETED   1   4 
Migrated/moved from study area                0                1 
Withdrawal by Subject                0                1 
Lost to Follow-up                1                2 



  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
Boostrix Polio Group Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
Repevax Group Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
Total Total of all reporting groups

Baseline Measures
   Boostrix Polio Group   Repevax Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 255   130   385 
Age 
[Units: Years]
Mean (Standard Deviation)
 3.1  (0.2)   3.1  (0.2)   3.1  (0.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      123  48.2%      65  50.0%      188  48.8% 
Male      132  51.8%      65  50.0%      197  51.2% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
African heritage/African American   2   4   6 
Asian-Central/South Asian heritage   4   4   8 
Asian-South East Asian heritage   3   1   4 
White-Arabic/North African heritage   2   1   3 
White-Caucasian/European heritage   226   111   337 
Not specified   18   9   27 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects With a Booster Response to Diphtheria (D) and Tetanus (T) Antigens   [ Time Frame: At Month 1, one month after the booster vaccination ]

2.  Primary:   Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations   [ Time Frame: At Month 1, one month after the booster vaccination ]

3.  Primary:   Anti-Polio Virus Type 1, 2 and 3 Antibody Titers   [ Time Frame: At Month 1, one month after the booster vaccination ]

4.  Secondary:   Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T)   [ Time Frame: Before (Month 0) and one month after (Month 1) the booster vaccination ]

5.  Secondary:   Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN   [ Time Frame: Before (Month 0) and one month after (Month 1) the booster vaccination ]

6.  Secondary:   Number of Seroprotected Subjects Against Polio Type 1, 2 and 3   [ Time Frame: Before (Month 0) and one month after (Month 1) the booster vaccination ]

7.  Secondary:   Number of Seropositive Subjects for Anti-measles Antibody   [ Time Frame: Before (Month 0) and one month after (Month 1) the booster vaccination ]

8.  Secondary:   Number of Seropositive Subjects for Anti-mumps Antibody   [ Time Frame: Before (Month 0) and one month after (Month 1) the booster vaccination ]

9.  Secondary:   Number of Seropositive Subjects for Anti-rubella Antibody   [ Time Frame: Before (Month 0) and one month after (Month 1) the booster vaccination ]

10.  Secondary:   Anti-D and Anti-T Antibody Concentrations   [ Time Frame: Before (Month 0) and one month after (Month 1) the booster vaccination ]

11.  Secondary:   Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations   [ Time Frame: At Month 0, before the booster vaccination ]

12.  Secondary:   Anti-mumps Antibody Concentrations   [ Time Frame: Before (Month 0) and one month after (Month 1) the booster vaccination ]

13.  Secondary:   Anti-measles Antibody Concentrations   [ Time Frame: Before (Month 0) and one month after (Month 1) the booster vaccination ]

14.  Secondary:   Anti-rubella Antibody Concentrations   [ Time Frame: Before (Month 0) and one month after (Month 1) the booster vaccination ]

15.  Secondary:   Anti-Polio Type 1, 2 and 3 Antibody Titers   [ Time Frame: At Month 0, before the booster vaccination ]

16.  Secondary:   Number of Subjects With a Booster Response to PT, FHA and PRN Antigens   [ Time Frame: At Month 1, one month after the booster vaccination ]

17.  Secondary:   Number of Subjects With Booster Response for Polio Type 1, 2 and 3 Antigens   [ Time Frame: At Month 1, one month after the booster vaccination ]

18.  Secondary:   Number of Seroconverted Subjects for Anti-measles   [ Time Frame: Before (Month 0) and one month after (Month 1) the booster vaccination ]

19.  Secondary:   Number of Seroconverted Subjects for Anti-mumps   [ Time Frame: Before (Month 0) and one month after (Month 1) the booster vaccination ]

20.  Secondary:   Number of Subjects With Any Solicited Local Symptoms   [ Time Frame: During the 4-day (Days 0–3) follow-up period after booster vaccination ]

21.  Secondary:   Number of Subjects With Any Solicited General Symptoms   [ Time Frame: During the 4-day (Days 0-3) follow-up period after booster vaccination ]

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

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


  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



Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01245049     History of Changes
Other Study ID Numbers: 111763
First Submitted: November 18, 2010
First Posted: November 22, 2010
Results First Submitted: February 24, 2017
Results First Posted: July 5, 2017
Last Update Posted: July 5, 2017