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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00109343
First Posted: April 27, 2005
Last Update Posted: April 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):
Merck Sharp & Dohme Corp.
Results First Submitted: September 23, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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 
Other                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 
Overall Participants Analyzed 
[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) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      230  45.1%      120  46.5%      117  45.2%      467  45.5% 
Male      280  54.9%      138  53.5%      142  54.8%      560  54.5% 
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
  Show All Outcome Measures

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: Senior Vice President, Global Clinical Development
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
First Submitted: April 27, 2005
First Posted: April 27, 2005
Results First Submitted: September 23, 2009
Results First Posted: February 10, 2010
Last Update Posted: April 12, 2017