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Immunogenicity and Safety Study of PriorixTetra™ When Co-administered With Conjugated MenC Vaccine in Healthy Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01506193
First received: January 5, 2012
Last updated: February 10, 2017
Last verified: February 2017
Results First Received: November 8, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Prevention
Conditions: Rubella
Varicella
Measles
Mumps
Interventions: Biological: PriorixTetra™
Biological: Meningitec

  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
Priorix-Tetra + Meningitec Group Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
Priorix-Tetra Group Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
Meningitec Group Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.

Participant Flow:   Overall Study
    Priorix-Tetra + Meningitec Group   Priorix-Tetra Group   Meningitec Group
STARTED   351   183   182 
COMPLETED   337   179   168 
NOT COMPLETED   14   4   14 
Protocol Violation                1                0                1 
Migrated/moved from study area                0                0                1 
Adverse event, non-fatal                0                0                1 
Withdrawal by Subject                5                1                8 
Lost to Follow-up                8                3                3 



  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
Priorix-Tetra + Meningitec Group Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
Priorix-Tetra Group Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
Meningitec Group Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
Total Total of all reporting groups

Baseline Measures
   Priorix-Tetra + Meningitec Group   Priorix-Tetra Group   Meningitec Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 351   183   182   716 
Age 
[Units: Months]
Mean (Standard Deviation)
 13.4  (0.6)   13.4  (0.6)   13.4  (0.7)   13.4  (0.63) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      167  47.6%      85  46.4%      88  48.4%      340  47.5% 
Male      184  52.4%      98  53.6%      94  51.6%      376  52.5% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Seroconverted Subjects for Measles, Mumps, Rubella, and Varicella Virus   [ Time Frame: At 42 days after vaccination ]

2.  Primary:   Number of Seroprotected Subjects for rSBA-MenC Antibodies   [ Time Frame: At 42 days after vaccination ]

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

4.  Secondary:   Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms   [ Time Frame: During the 15-day (Days 0-14) post-vaccination period ]

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

6.  Secondary:   Number of Subjects Reporting Fever Per Half Degree   [ Time Frame: During the 43-day (Days 0-42) post-vaccination period ]

7.  Secondary:   Number of Subjects Reporting Any, Localised and Generalised Rashes   [ Time Frame: Within the 43-day (Days 0-42) post-vaccination period ]

8.  Secondary:   Number of Subjects With Any Unsolicited Adverse Events (AEs)   [ Time Frame: Within 43 days (Days 0-42) after each vaccination ]

9.  Secondary:   Number of Subjects With Serious Adverse Events (SAEs)   [ Time Frame: Throughout study period (from Day 0 to approximately Month 4) ]

10.  Secondary:   Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses   [ Time Frame: At Day 42 after vaccination ]


  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: NCT01506193     History of Changes
Other Study ID Numbers: 115555
2011-001608-37 ( EudraCT Number )
Study First Received: January 5, 2012
Results First Received: November 8, 2016
Last Updated: February 10, 2017