ClinicalTrials.gov
ClinicalTrials.gov Menu

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Children in Their Second Year of Life

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.
ClinicalTrials.gov Identifier: NCT01681992
Recruitment Status : Completed
First Posted : September 10, 2012
Results First Posted : August 17, 2018
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Measles
Mumps
Rubella
Interventions: Biological: Priorix
Biological: M-M-R II
Biological: Varivax
Biological: Havrix
Biological: Prevnar 13

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
US sub-cohort: Subjects recruited in US and received Inv_MMR_Min or Inv_MMR_Med or Com_MMR (Lot 1 or 2) co-administered with Varivax (VV), Havrix (HAV) and Prevnar 13 (PCV-13) at Day 0. Non-US sub-cohort: Subjects recruited outside US and received Inv_MMR_Min or Inv_MMR_Med or Com_MMR (Lot 1 or 2) co-administered with VV and HAV at Day 0.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
4538 subjects were registered in the study. 3 subjects were excluded because of invalid Informed Consent Forms and 19 subjects received a subject number but were not vaccinated. Therefore, the number of subjects started is 4516.

Reporting Groups
  Description
Inv_MMR_Min Group Subjects received one dose of GlaxoSmithKline (GSK) Biologicals’ measles, mumps, rubella (MMR) vaccine, Priorix (Inv_MMR), from a minimum potency lot (Inv_MMR_Min), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects were also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Inv_MMR_Med Group Subjects received one dose of GlaxoSmithKline (GSK) Biologicals’ measles, mumps, rubella (MMR) vaccine, Priorix (Inv_MMR), from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects were also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Com_MMR Group Subjects received one dose of M-M-R II (Com_MMR) vaccine (Lot 1 or Lot 2), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects were also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.

Participant Flow:   Overall Study
    Inv_MMR_Min Group   Inv_MMR_Med Group   Com_MMR Group
STARTED   1493   1497   1526 
COMPLETED   1427   1427   1443 
NOT COMPLETED   66   70   83 
Adverse Event                3                2                3 
Lost to Follow-up                36                38                53 
As Per Sponsor Decision                0                0                1 
Protocol Violation                0                0                1 
Withdrawal by Subject                27                30                25 



  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
Inv_MMR_Min Group Subjects received one dose of Inv_MMR, from a minimum potency lot (Inv_MMR_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Inv_MMR_Med Group Subjects received one dose of Inv_MMR, from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Com_MMR Group Subjects received one dose of Com_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
Total Total of all reporting groups

Baseline Measures
   Inv_MMR_Min Group   Inv_MMR_Med Group   Com_MMR Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 1493   1497   1526   4516 
Age 
[Units: Months]
Mean (Standard Deviation)
 12.6  (0.9)   12.6  (0.9)   12.6  (0.9)   12.6  (0.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      704  47.2%      718  48.0%      758  49.7%      2180  48.3% 
Male      789  52.8%      779  52.0%      768  50.3%      2336  51.7% 
Race/Ethnicity, Customized 
[Units: Participants]
       
African Heritage / African American   45   53   46   144 
American Indian or Alaskan Native   2   1   1   4 
Asian - Central/South Asian Heritage   1   0   2   3 
Asian - East Asian Heritage   3   0   1   4 
Asian - South East Asian Heritage   362   366   367   1095 
Native Hawaiian or Other Pacific Islander   0   1   0   1 
White - Arabic / North African Heritage   8   8   8   24 
White - Caucasian / European Heritage   1017   1022   1052   3091 
Other   55   46   49   150 


  Outcome Measures

1.  Primary:   Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value (by Enzyme-linked Immunosorbent Assay [ELISA])   [ Time Frame: At Day 42 ]

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

3.  Primary:   Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value (by Plaque Reduction Neutralization Test [PRNT])   [ Time Frame: At Day 42 ]

4.  Primary:   Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)   [ Time Frame: At Day 42 ]

5.  Primary:   Anti-measles Virus Antibody Concentrations (by ELISA)   [ Time Frame: At Day 42 ]

6.  Primary:   Anti-mumps Virus Antibody Concentrations (by ELISA)   [ Time Frame: At Day 42 ]

7.  Primary:   Anti-mumps Virus Antibody Concentrations (by PRNT)   [ Time Frame: At Day 42 ]

8.  Primary:   Anti-rubella Virus Antibody Concentrations (by ELISA)   [ Time Frame: At Day 42 ]

9.  Secondary:   Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)   [ Time Frame: At Day 84 ]

10.  Secondary:   Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)   [ Time Frame: At Day 84 ]

11.  Secondary:   Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)   [ Time Frame: At Day 84 ]

12.  Secondary:   Anti-measles Virus Antibody Concentrations (by ELISA)   [ Time Frame: At Day 84 ]

13.  Secondary:   Anti-mumps Virus Antibody Concentrations (by ELISA)   [ Time Frame: At Day 84 ]

14.  Secondary:   Anti-rubella Virus Antibody Concentrations (by ELISA)   [ Time Frame: At Day 84 ]

15.  Secondary:   Number of Subjects With Any Solicited Local Adverse Events (AEs) Post Dose 1   [ Time Frame: During the 4-day (Days 0-3) post-vaccination period ]

16.  Secondary:   Number of Subjects With Any Solicited Local AEs Post Dose 2   [ Time Frame: During the 4-day (Days 0-3) post-vaccination period ]

17.  Secondary:   Number of Subjects With Any Solicited General AEs Post Dose 1   [ Time Frame: During the 15-day (Days 0-14) post-vaccination period ]

18.  Secondary:   Number of Subjects Reporting Any Fever Post Dose 1   [ Time Frame: During the 43-day (Days 0-42) post-vaccination period ]

19.  Secondary:   Number of Subjects Reporting Any Fever Post Dose 2   [ Time Frame: During the 43-day (Days 0-42) post-vaccination period ]

20.  Secondary:   Number of Subjects Reporting Any Rash Post Dose 1   [ Time Frame: During the 43-day (Days 0-42) post-vaccination period ]

21.  Secondary:   Number of Subjects Reporting Any Rash Post Dose 2   [ Time Frame: During the 43-day (Days 0-42) post-vaccination period ]

22.  Secondary:   Number of Subjects Reporting Any MMR Specific Solicited General AEs Post Dose 1   [ Time Frame: During the 43-day (Days 0-42) post-vaccination period ]

23.  Secondary:   Number of Subjects Reporting Any MMR Specific Solicited General AEs Post Dose 2   [ Time Frame: During the 43-day (Days 0-42) post-vaccination period ]

24.  Secondary:   Number of Subjects Reporting Any Unsolicited AES Post Dose 1   [ Time Frame: During the 43-day (Days 0-42) post-vaccination period ]

25.  Secondary:   Number of Subjects Reporting Any Unsolicited AES Post Dose 2   [ Time Frame: During the 43-day (Days 0-42) post-vaccination period ]

26.  Secondary:   Number of Subjects Reporting Any AEs of Specific Interest   [ Time Frame: From Day 0 through the end of the study (Day 222) ]

27.  Secondary:   Number of Subjects Reporting Any Serious Adverse Events (SAEs)   [ Time Frame: From Day 0 through the end of the study (Day 222) ]


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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01681992     History of Changes
Other Study ID Numbers: 115649
2011-004905-26 ( EudraCT Number )
First Submitted: September 6, 2012
First Posted: September 10, 2012
Results First Submitted: December 30, 2016
Results First Posted: August 17, 2018
Last Update Posted: August 17, 2018