Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella Virus Vaccine Live Safety Study (V251-066)(COMPLETED)
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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: NCT00326183 |
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Recruitment Status :
Completed
First Posted : May 16, 2006
Results First Posted : November 20, 2008
Last Update Posted : February 4, 2019
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Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention |
| Conditions |
Hepatitis A Measles Mumps Rubella Chickenpox |
| Interventions |
Biological: VAQTA® Biological: ProQuad |
| Enrollment | 1800 |
Participant Flow
| Recruitment Details |
18 investigators in the United States; Date of first subject visit: 26-Mar-2007. Date of last subject visit: 14-Nov-2007. |
| Pre-assignment Details |
| Arm/Group Title | Arm 1: VAQTA™ | Arm 2: VAQTA™ +ProQuad™ |
|---|---|---|
 Arm/Group Description |
Hepatitis A vaccine, inactivated | Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live |
| Period Title: Overall Study | ||
| Started | 1453 | 347 |
| Vaccination 1 + Safety Follow-up | 1453 | 347 |
| Postvaccination 1 Post-safety Follow-up | 1393 | 325 |
| Vaccination 2 + Safety Follow-up | 1301 | 292 |
| Postvaccination 2 Post-safety Follow-up | 1265 | 271 |
| Completed | 1253 | 264 |
| Not Completed | 200 | 83 |
| Reason Not Completed | ||
| Lost to Follow-up | 104 | 56 |
| Protocol Violation | 6 | 3 |
| Withdrawal by Subject | 35 | 7 |
| Subject Moved | 7 | 4 |
| Other | 47 | 13 |
| Adverse Event | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | Arm 1: VAQTA™ | Arm 2: VAQTA™ +ProQuad™ | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Hepatitis A vaccine, inactivated | Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live | Total of all reporting groups | |
| Overall Number of Baseline Participants | 1453 | 347 | 1800 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Months |
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| Number Analyzed | 1453 participants | 347 participants | 1800 participants | |
| 13.3 (1.49) | 12.5 (0.90) | 13.2 (1.43) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 1453 participants | 347 participants | 1800 participants | |
| Female |
703 48.4%
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176 50.7%
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879 48.8%
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| Male |
750 51.6%
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171 49.3%
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921 51.2%
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Outcome Measures
Adverse Events
No Adverse Events Reported
Limitations and Caveats
[Not Specified]
More Information
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.
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
| Name/Title: | Senior Vice President, Clinical and Quantitative Sciences |
| Organization: | Merck Sharp & Dohme Corp |
| Phone: | 1-800-672-6372 |
| Responsible Party: | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT00326183 |
| Other Study ID Numbers: |
V251-066 2006_023 |
| First Submitted: | May 12, 2006 |
| First Posted: | May 16, 2006 |
| Results First Submitted: | October 21, 2008 |
| Results First Posted: | November 20, 2008 |
| Last Update Posted: | February 4, 2019 |