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Study of Two Formulations of GSK Biologicals' Varicella Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00568334
First received: December 5, 2007
Last updated: April 13, 2017
Last verified: April 2017
Results First Received: April 13, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition: Varicella
Intervention: Biological: Varilrix (inactivated varicella 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
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
Varilrix HSA-Free Group Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
Varilrix Group Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).

Participant Flow:   Overall Study
    Varilrix HSA-Free Group   Varilrix Group
STARTED   122   122 
COMPLETED   121   121 
NOT COMPLETED   1   1 
Withdrawal by Subject                0                1 
Lost to Follow-up                1                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
Varilrix HSA-Free Group Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
Varilrix Group Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6).
Total Total of all reporting groups

Baseline Measures
   Varilrix HSA-Free Group   Varilrix Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 122   122   244 
Age 
[Units: Months]
Mean (Standard Deviation)
 15.6  (3.34)   14.8  (3.08)   15.20  (3.23) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      59  48.4%      60  49.2%      119  48.8% 
Male      63  51.6%      62  50.8%      125  51.2% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
White-Caucasian/European heritage   122   122   244 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Antibody Titers Against Varicella Zoster Virus (VZV)   [ Time Frame: At 43-57 days after the first vaccine dose (Week 6) ]

2.  Primary:   Antibody Concentrations Against Varicella Zoster Virus (VZV)   [ Time Frame: At 43-57 days after the first vaccine dose (Week 6) ]

3.  Secondary:   Number of Seroconverted Subjects for Varicella Antibodies   [ Time Frame: At 43-57 days post-Dose 1 (Week 6) and 86-114 days post-Dose 2 (Week 12) ]

4.  Secondary:   Number of Subjects With Anti-VZV Antibody Concentrations Above Cut-off Values   [ Time Frame: At 43-57 days post-Dose 1 (Week 6) and 86-114 days post-Dose 2 (Week 12) ]

5.  Secondary:   Antibody Titers Against Varicella Zoster Virus (VZV)   [ Time Frame: At 86-114 days after the second vaccine dose (Week 12) ]

6.  Secondary:   Antibody Concentrations Against Varicella Zoster Virus (VZV)   [ Time Frame: At 86-114 days after the second vaccine dose (Week 12) ]

7.  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 dose ]

8.  Secondary:   Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms   [ Time Frame: During the 43-day (Days 0-42) post-vaccination period following each dose ]

9.  Secondary:   Number of Subjects With Any Unsolicited Adverse Event (AE)   [ Time Frame: Within the 43-day (Days 0-42) post-vaccination period following each dose ]

10.  Secondary:   Number of Subjects With Serious Adverse Events (SAEs)   [ Time Frame: From Day 0 up to study end (Day 86-114) ]


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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00568334     History of Changes
Other Study ID Numbers: 109705
Study First Received: December 5, 2007
Results First Received: April 13, 2017
Last Updated: April 13, 2017