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Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Subjects Four to Six Years of Age

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01621802
First Posted: June 18, 2012
Last Update Posted: October 12, 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: October 18, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Rubella
Mumps
Measles
Interventions: Biological: Priorix
Biological: M-M-R II
Biological: Kinrix
Biological: ProQuad

  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
Subjects were enrolled in 3 sub-cohorts. Sub-cohort 1: Inv_MMR_CO and Com_MMR_CO (Lot 1 or Lot 2), Sub-cohort 2: Inv_MMR_I and Com_MMR_I (Lot 1 or Lot 2) and Sub-cohort 3: Inv_MMR_S and Com_MMR_S (Lot 1 or Lot 2).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
4011 subjects were enrolled in the study with 4007 eligible subjects receiving a study vaccination.

Reporting Groups
  Description
Inv_MMR_CO Group Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Com_MMR_CO Group Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Inv_MMR_I Group Subjects received one dose of Priorix at Visit 1 (Day 0).
Com_MMR_I Group Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Inv_MMR_S Group Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).
Com_MMR_S Group Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).

Participant Flow:   Overall Study
    Inv_MMR_CO Group   Com_MMR_CO Group   Inv_MMR_I Group   Com_MMR_I Group   Inv_MMR_S Group   Com_MMR_S Group
STARTED   802   298   796   303   1319   489 
COMPLETED   755   275   763   292   1284   477 
NOT COMPLETED   47   23   33   11   35   12 
Protocol Violation                0                0                0                0                0                1 
Withdrawal by Subject                8                4                4                2                2                0 
Migrated/moved from study area                0                0                2                0                1                0 
Others                3                3                3                2                1                0 
Lost to Follow-up                36                16                24                7                31                11 



  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
Inv_MMR_CO Group Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Com_MMR_CO Group Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0).
Inv_MMR_I Group Subjects received one dose of Priorix at Visit 1 (Day 0).
Com_MMR_I Group Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Inv_MMR_S Group Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0).
Com_MMR_S Group Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Total Total of all reporting groups

Baseline Measures
   Inv_MMR_CO Group   Com_MMR_CO Group   Inv_MMR_I Group   Com_MMR_I Group   Inv_MMR_S Group   Com_MMR_S Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 802   298   796   303   1319   489   4007 
Age 
[Units: Years]
Mean (Standard Deviation)
 4.1  (0.3)   4.1  (0.3)   4.4  (0.6)   4.3  (0.6)   4.4  (0.6)   4.4  (0.6)   4.3  (0.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
             
Female      398  49.6%      134  45.0%      361  45.4%      153  50.5%      632  47.9%      225  46.0%      1903  47.5% 
Male      404  50.4%      164  55.0%      435  54.6%      150  49.5%      687  52.1%      264  54.0%      2104  52.5% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
             
Race/Ethnicity               
African Heritage / African American      96  12.0%      39  13.1%      48   6.0%      19   6.3%      94   7.1%      32   6.5%      328   8.2% 
American Indian or Alaskan Native      130  16.2%      38  12.8%      15   1.9%      3   1.0%      4   0.3%      0   0.0%      190   4.7% 
Asian - Central/South Asian Heritage      12   1.5%      5   1.7%      7   0.9%      1   0.3%      8   0.6%      0   0.0%      33   0.8% 
Asian - East Asian Heritage      28   3.5%      6   2.0%      384  48.2%      146  48.2%      565  42.8%      209  42.7%      1338  33.4% 
Asian - Japanese Heritage      3   0.4%      0   0.0%      0   0.0%      1   0.3%      1   0.1%      0   0.0%      5   0.1% 
Asian - South East Asian Heritage      49   6.1%      25   8.4%      11   1.4%      4   1.3%      16   1.2%      8   1.6%      113   2.8% 
Native Hawaiian or Other Pacific Islander      4   0.5%      2   0.7%      2   0.3%      0   0.0%      3   0.2%      0   0.0%      11   0.3% 
Other      112  14.0%      45  15.1%      35   4.4%      9   3.0%      52   3.9%      22   4.5%      275   6.9% 
White - Arabic / North African Heritage      5   0.6%      3   1.0%      3   0.4%      3   1.0%      1   0.1%      0   0.0%      15   0.4% 
White - Caucasian / European Heritage      363  45.3%      135  45.3%      291  36.6%      117  38.6%      575  43.6%      218  44.6%      1699  42.4% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value   [ Time Frame: 42 days post vaccination (At Day 42) ]

2.  Primary:   Number of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value   [ Time Frame: 42 days post vaccination (At Day 42) ]

3.  Primary:   Number of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value   [ Time Frame: 42 days post vaccination (At Day 42) ]

4.  Primary:   Evaluation of Immunogenicity in Terms of Anti-measles Virus Antibody Concentrations   [ Time Frame: 42 days after vaccination (At Day 42) ]

5.  Primary:   Evaluation of Immunogenicity in Terms of Anti-mumps Virus Antibody Concentrations   [ Time Frame: 42 days post vaccination (At Day 42) ]

6.  Primary:   Evaluation of Immunogenicity in Terms of Anti-rubella Virus Antibody Concentrations   [ Time Frame: 42 days post vaccination (At Day 42) ]

7.  Secondary:   Number of Subjects With Anti-varicella Zoster Virus (VZV) Antibody Concentration Equal to or Above the Cut-off-value   [ Time Frame: 42 days post vaccination (At Day 42) ]

8.  Secondary:   Evaluation of Immunogenicity in Terms of Anti-VZV Antibody Concentrations   [ Time Frame: 42 days post vaccination (At Day 42) ]

9.  Secondary:   Number of Subjects With Antibody Booster Response to Diphtheria Toxin (Anti-D) and Tetanus Toxin (Anti-T)   [ Time Frame: 42 days post vaccination (At Day 42) ]

10.  Secondary:   Number of Subjects With Antibody Booster Response to Pertussis Toxin (PT)   [ Time Frame: 42 days post vaccination (At Day 42) ]

11.  Secondary:   Number of Subjects With Antibody Booster Response to Filamentous Hemagglutinin (FHA)   [ Time Frame: 42 days post vaccination (At Day 42) ]

12.  Secondary:   Number of Subjects With Antibody Booster Response to Pertactin (PRN)   [ Time Frame: 42 days post vaccination (At Day 42) ]

13.  Secondary:   Evaluation of Immunogenicity in Terms of Anti-D and Anti-T Antibody Concentrations   [ Time Frame: 42 days post vaccination (At Day 42) ]

14.  Secondary:   Evaluation of Immunogenicity in Terms of Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations   [ Time Frame: 42 days post vaccination (At Day 42) ]

15.  Secondary:   Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL   [ Time Frame: 42 days post vaccination (At Day 42) ]

16.  Secondary:   Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 1.0 IU/mL   [ Time Frame: 42 days post vaccination (At Day 42) ]

17.  Secondary:   Evaluation of Immunogenicity in Terms of Anti-polio Virus Types 1, 2 and 3 Antibody Titers   [ Time Frame: 42 days post vaccination (At Day 42) ]

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

19.  Secondary:   Number of Subjects With Solicited General Symptoms   [ Time Frame: During the 4-day (Days 0-3) post-vaccination period ]

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

21.  Secondary:   Number of Subjects Reporting MMR Specific Solicited General Symptoms   [ Time Frame: During the 43-day (Days 0-42) post-vaccination period ]

22.  Secondary:   Number of Subjects Reporting Investigator-confirmed Rash   [ Time Frame: During the 43-day (Days 0-42) post-vaccination period ]

23.  Secondary:   Number of Subjects With New Onset Chronic Diseases (NOCDs)   [ Time Frame: During the entire study period (from Day 0 up to Day 180) ]

24.  Secondary:   Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits   [ Time Frame: During the entire study period (from Day 0 up to Day 180) ]

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

26.  Secondary:   Number of Subjects With Serious Adverse Events (SAEs)   [ Time Frame: During the entire study period (from Day 0 up to Day 180) ]


  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



Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01621802     History of Changes
Other Study ID Numbers: 115158
2011-004638-32 ( EudraCT Number )
First Submitted: June 14, 2012
First Posted: June 18, 2012
Results First Submitted: October 18, 2016
Results First Posted: September 13, 2017
Last Update Posted: October 12, 2017