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Safety Study of ProQuad® rHA in Infants (V221-037)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00560755
First Posted: November 20, 2007
Last Update Posted: October 17, 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 18, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: Measles
Mumps
Rubella
Varicella
Intervention: Biological: ProQuad®

  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
Healthy pediatric participants were enrolled at 84 study centers in 7 European countries.

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
ProQuad® Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.

Participant Flow:   Overall Study
    ProQuad®
STARTED   3388 [1] 
ProQuad® Dose 1 and Dose 2   3346 
COMPLETED   3328 
NOT COMPLETED   60 
Protocol Violation                15 
Withdrawal by Subject                26 
Lost to Follow-up                9 
Adverse Event                8 
Physician Decision                2 
[1] Vaccinated (at least one ProQuad® dose)



  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
ProQuad® Healthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.

Baseline Measures
   ProQuad® 
Overall Participants Analyzed 
[Units: Participants]
 3388 
Age 
[Units: Months]
Mean (Standard Deviation)
 14.6  (2.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      1650  48.7% 
Male      1738  51.3% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Experiencing an Adverse Event (AE) After ProQuad® Dose 2   [ Time Frame: Up to Day 70 (up to 28 days after ProQuad® Dose 2) ]

2.  Primary:   Percentage of Participants Experiencing a Vaccine-related AE After ProQuad® Dose 2   [ Time Frame: Up to Day 70 (up to 28 days after ProQuad® Dose 2) ]

3.  Primary:   Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 2   [ Time Frame: Up to Day 46 (for 4 days following ProQuad® Dose 2) ]

4.  Primary:   Percentage of Participants Experiencing a Unsolicited Injection-site AE After ProQuad® Dose 2   [ Time Frame: Up to Day 70 (up to 28 days after ProQuad® Dose 2) ]

5.  Primary:   Percentage of Participants Experiencing a Injection-site Rash of Interest AE After ProQuad® Dose 2   [ Time Frame: Up to Day 70 (up to 28 days after ProQuad® Dose 2) ]

6.  Primary:   Percentage of Participants Experiencing a Systemic AE After ProQuad® Dose 2   [ Time Frame: Up to Day 70 (up to 28 days after ProQuad® Dose 2) ]

7.  Primary:   Percentage of Participants Experiencing a Vaccine-related Systemic AE After ProQuad® Dose 2   [ Time Frame: Up to Day 70 (up to 28 days after ProQuad® Dose 2) ]

8.  Primary:   Percentage of Participants Experiencing a Non-injection-site Rash of Interest AE After ProQuad® Dose 2   [ Time Frame: Up to Day 70 (up to 28 days after ProQuad® Dose 2) ]

9.  Primary:   Percentage of Participants Experiencing a Mumps-like Illness After ProQuad® Dose 2   [ Time Frame: Up to Day 70 (up to 28 days after ProQuad® Dose 2) ]

10.  Primary:   Percentage of Participants Experiencing a Serious AE (SAE) After ProQuad® Dose 2   [ Time Frame: Up to Day 84 (up to 42 days after ProQuad® Dose 2) ]

11.  Primary:   Percentage of Participants Experiencing a Vaccine-related SAE After ProQuad® Dose 2   [ Time Frame: Up to Day 84 (up to 42 days after ProQuad® Dose 2) ]

12.  Secondary:   Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 1   [ Time Frame: From Day 1 to Day 4 (for 4 days following ProQuad® Dose 1) ]

13.  Secondary:   Percentage of Participants Experiencing a Unsolicited Injection-site AE After ProQuad® Dose 1   [ Time Frame: Up to Day 28 (28 days after ProQuad® Dose 1) ]

14.  Secondary:   Percentage of Participants With ≥ 1 Rectal Temperature Reading ≥ 38.0° C After ProQuad® Dose 1   [ Time Frame: Up to Day 28 (28 days after ProQuad® Dose 1) ]

15.  Secondary:   Percentage of Participants Experiencing a Systemic AE After ProQuad® Dose 1   [ Time Frame: Up to Day 28 (28 days after ProQuad® Dose 1) ]


  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
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  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
e-mail: ClinicalTrialsDisclosure@merck.com


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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00560755     History of Changes
Other Study ID Numbers: V221-037
MRV01C ( Other Identifier: Sanofi Pasteur MSD Protocol Number )
2007-002438-12 ( EudraCT Number )
First Submitted: November 19, 2007
First Posted: November 20, 2007
Results First Submitted: September 18, 2017
Results First Posted: October 17, 2017
Last Update Posted: October 17, 2017