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Immunogenicity & Safety Study of GSK Biologicals' Combined Measles-mumps-rubella-varicella Vaccine 208136

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ClinicalTrials.gov Identifier: NCT00751348
Recruitment Status : Completed
First Posted : September 11, 2008
Results First Posted : April 24, 2017
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: Measles
Varicella
Mumps
Rubella
Interventions: Biological: PriorixTM
Biological: VarilrixTM
Biological: Priorix-Tetra®

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Out of 475 subjects enrolled in the study, one did not receive any 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
Priorix-Tetra Group Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
Priorix + Varilrix Group Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.

Participant Flow:   Overall Study
    Priorix-Tetra Group   Priorix + Varilrix Group
STARTED   313   161 
COMPLETED   307   159 
NOT COMPLETED   6   2 
Withdrawal by Subject                5                2 
Migration from study area                1                0 



  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
Priorix-Tetra Group Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
Priorix + Varilrix Group Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
Total Total of all reporting groups

Baseline Measures
   Priorix-Tetra Group   Priorix + Varilrix Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 313   161   474 
Age 
[Units: Months]
Mean (Standard Deviation)
 12.4  (1.4)   12.5  (1.65)   12.43  (1.49) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      128  40.9%      76  47.2%      204  43.0% 
Male      185  59.1%      85  52.8%      270  57.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Asian–East Asian Heritage   313   159   472 
Asian-South East Asian Heritage   0   2   2 


  Outcome Measures

1.  Primary:   Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Zoster Virus (VZV) Antibodies Above the Cut-off Values   [ Time Frame: At 42 days post-vaccination ]

2.  Secondary:   Antibody Concentrations Against Measles   [ Time Frame: At 42-days post-vaccination ]

3.  Secondary:   Antibody Concentrations Against Mumps   [ Time Frame: At 42-days post-vaccination ]

4.  Secondary:   Antibody Concentrations Against Rubella   [ Time Frame: At 42-days post-vaccination ]

5.  Secondary:   Antibody Titers Against Varicela Viruses   [ Time Frame: At 42-days post-vaccination ]

6.  Secondary:   Number of Subjects With Any and Grade 3 Solicited Local Symptoms   [ Time Frame: During the 4-day (Days 0-3) post-vaccination period ]

7.  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 ]

8.  Secondary:   Number of Subjects With Any Unsolicited Adverse Events (AEs)   [ Time Frame: Within the 43-day (Days 0-42) post-vaccination period ]

9.  Secondary:   Number of Subjects With Serious Adverse Events (SAEs)   [ Time Frame: During the entire study period (from Day 0 up to Day 43 or Day 57) ]


  Serious Adverse Events


  Other Adverse Events


  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

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:
Sung-Ho Cha et al. Immunogenicity and safety of a tetravalent measles-mumps-rubella-varicella (MMRV) vaccine: an open-labeled, randomized trial in healthy Korean children. Abstract presented at the Fall Meeting of Korean Vaccine Society (KVS). Seoul, Korea, 31 August 2013.


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00751348     History of Changes
Other Study ID Numbers: 110876
First Submitted: September 10, 2008
First Posted: September 11, 2008
Results First Submitted: March 13, 2017
Results First Posted: April 24, 2017
Last Update Posted: June 8, 2018