V221 Concomitant Use Study With Pneumococcal Conjugate Vaccine (V221-019)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00109343
First received: April 27, 2005
Last updated: March 4, 2014
Last verified: March 2014
Results First Received: September 23, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Measles
Mumps
Rubella
Varicella
Interventions: Biological: Comparator: ProQuad™ (V221)
Biological: Comparator: PREVNAR™ (pneumococcal 7-valent conjugate 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

24 clinical sites in the United States

Date first participant visit: 06-Mar-2006

Date last participant visit: 14-Sep-2007


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Group 1 - ProQuad™ + PREVNAR™ Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
Group 2 - PREVNAR™ Followed by ProQuad™ Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
Group 3 - ProQuad™ Followed by PREVNAR™ Group 3 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.

Participant Flow:   Overall Study
    Group 1 - ProQuad™ + PREVNAR™     Group 2 - PREVNAR™ Followed by ProQuad™     Group 3 - ProQuad™ Followed by PREVNAR™  
STARTED     510     258     259  
Vaccinated at Visit 1     510     258     259  
Vaccinated at Visit 2     0 [1]   246     246  
Vaccinated at Visit 4     466     235     240  
COMPLETED     446     221     229  
NOT COMPLETED     64     37     30  
Adverse Event                 1                 0                 2  
Lack of Efficacy                 1                 0                 0  
Lost to Follow-up                 35                 20                 14  
Protocol Violation                 1                 2                 2  
Withdrawal by Subject                 15                 11                 10  
Subject Moved                 6                 2                 1  
Unspecified                 5                 2                 1  
[1] Per-protocol, subjects in Group 1 were not vaccinated at Visit 2



  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
Group 1 - ProQuad™ + PREVNAR™ Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
Group 2 - PREVNAR™ Followed by ProQuad™ Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
Group 3 - ProQuad™ Followed by PREVNAR™ Group 3 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
Total Total of all reporting groups

Baseline Measures
    Group 1 - ProQuad™ + PREVNAR™     Group 2 - PREVNAR™ Followed by ProQuad™     Group 3 - ProQuad™ Followed by PREVNAR™     Total  
Number of Participants  
[units: participants]
  510     258     259     1027  
Age  
[units: Months]
Mean ± Standard Deviation
  12.6  ± 0.96     12.5  ± 0.93     12.6  ± 0.98     12.6  ± 0.96  
Gender  
[units: participants]
       
Female     230     120     117     467  
Male     280     138     142     560  
Race/Ethnicity, Customized  
[units: participants]
       
Asian     18     5     8     31  
Black     83     36     36     155  
Hispanic     46     31     26     103  
White     335     161     174     670  
Other     28     25     15     68  



  Outcome Measures
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1.  Primary:   Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥255 mIU/mL   [ Time Frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone ]

2.  Primary:   Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL   [ Time Frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone ]

3.  Primary:   Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL   [ Time Frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone ]

4.  Primary:   Number of Participants With Postvaccination Varicella Antibody Titer ≥1.25 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL and ≥5 gpELISA Units/mL   [ Time Frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone ]

5.  Primary:   Antibody Response to S. Pneumoniae Serotype 4 – Geometric Mean Titer   [ Time Frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone ]

6.  Primary:   Antibody Response to S. Pneumoniae Serotype 6B – Geometric Mean Titer   [ Time Frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone. ]

7.  Primary:   Antibody Response to S. Pneumoniae Serotype 9V – Geometric Mean Titer   [ Time Frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone ]

8.  Primary:   Antibody Response to S. Pneumoniae Serotype 14 – Geometric Mean Titer   [ Time Frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone ]

9.  Primary:   Antibody Response to S. Pneumoniae Serotype 18C – Geometric Mean Titer   [ Time Frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone ]

10.  Primary:   Antibody Response to S. Pneumoniae Serotype 19F – Geometric Mean Titer   [ Time Frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone ]

11.  Primary:   Antibody Response to S. Pneumoniae Serotype 23F – Geometric Mean Titer   [ Time Frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone ]

12.  Other Pre-specified:   Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 4   [ Time Frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone ]

13.  Other Pre-specified:   Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 6B   [ Time Frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone ]

14.  Other Pre-specified:   Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 9V   [ Time Frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone ]

15.  Other Pre-specified:   Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 14   [ Time Frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone ]

16.  Other Pre-specified:   Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 18C   [ Time Frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone ]

17.  Other Pre-specified:   Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 19F   [ Time Frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone ]

18.  Other Pre-specified:   Number of Participants With Postvaccination Pneumococcal Polysaccharide ELISA Titer ≥0.2 mcg/mL for S. Pneumoniae Serotype 23F   [ Time Frame: 6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving a fourth dose of Prevnar™ alone ]


  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
One subject (Group 3-ProQuad™ followed by PREVNAR™) was diagnosed (Day 8) with Stage IV neuroblastoma (considered not related to study vaccine by investigator) and discontinued from the study. Subject died (Day 218) due to neuroblastoma.


  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: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00109343     History of Changes
Other Study ID Numbers: V221-019, 2005_027
Study First Received: April 27, 2005
Results First Received: September 23, 2009
Last Updated: March 4, 2014
Health Authority: United States: Food and Drug Administration