ROTATEQ Reexamination Study (V260-037 AM3)
This study is currently recruiting participants.
Verified March 2013 by Merck
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01074242
First received: February 22, 2010
Last updated: March 22, 2013
Last verified: March 2013
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | February 22, 2010 | ||||
| Last Updated Date | March 22, 2013 | ||||
| Start Date ICMJE | September 2007 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Percentage of participants with any adverse experience [ Time Frame: During or within 42 days following the first vaccination and from the time of any subsequent vaccination through 42 days thereafter ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
Percent of subjects with clinical and/or laboratory adverse events [ Time Frame: Day 0-42 after each vaccination ] [ Designated as safety issue: Yes ] | ||||
| Change History | Complete list of historical versions of study NCT01074242 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | ROTATEQ Reexamination Study (V260-037 AM3) | ||||
| Official Title ICMJE | Re-examination Study for General Vaccine Use to Assess the Safety Profile of ROTATEQ in Usual Practice | ||||
| Brief Summary | This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of Rotateq through collecting the safety information according to the Re-examination Regulation for New Drugs. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | 6-32 week old Korean Infants who are vaccinated with Rotateq in usual practice |
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| Condition ICMJE | Gastroenteritis Rotavirus | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Korean Infants vaccinated with Rotateq | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 3600 | ||||
| Estimated Completion Date | June 2013 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 6 Weeks to 32 Weeks | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Korea, Republic of | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01074242 | ||||
| Other Study ID Numbers ICMJE | V260-037, 2010_012 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Merck | ||||
| Study Sponsor ICMJE | Merck | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Merck | ||||
| Verification Date | March 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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