Rotavirus Infections Clinical Trial
Official title:
Study of the Efficacy, Safety, and Immunogenicity of V260 at Expiry
Verified date | September 2015 |
Source | Merck Sharp & Dohme Corp. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This study was designed to evaluate the safety of the investigational Rotavirus Vaccine and the efficacy to prevent Rotavirus Gastroenteritis.
Status | Completed |
Enrollment | 1312 |
Est. completion date | June 2004 |
Est. primary completion date | June 2004 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 6 Weeks to 12 Weeks |
Eligibility |
Inclusion Criteria: - Healthy infants Exclusion Criteria: - History of abdominal disorders from a birth defect, intussusception, or abdominal surgery - Known or suspected problems with immune system - Fever at time of immunization - Prior administration of a rotavirus vaccine - History of known prior rotavirus disease - Chronic diarrhea, or failure to thrive |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Merck Sharp & Dohme Corp. |
Block SL, Vesikari T, Goveia MG, Rivers SB, Adeyi BA, Dallas MJ, Bauder J, Boslego JW, Heaton PM; Pentavalent Rotavirus Vaccine Dose Confirmation Efficacy Study Group. Efficacy, immunogenicity, and safety of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine at the end of shelf life. Pediatrics. 2007 Jan;119(1):11-8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurence of Clinical Rotavirus Disease Caused by the Composite of the Serotypes Contained Within the Vaccine More Than 14 Days Following the Third Dose. | G1, G2, G3, and G4 Serotype Rotavirus Gastroenteritis Cases Occurring at Least 14 Days Postdose 3 Through the First Rotavirus Season Postvaccination in the Per-Protocol Population Using Per-Protocol Case Definition | At least 14 days following the 3rd vaccination | No |
Secondary | Number of Subjects With =3 Fold Rise in Antibody Titer | Induction of postdose 3 rotavirus Serum neutralizing antibody (SNA) response (Number of subjects with =3 fold rise in antibody titer) | 14 days following the 3rd vaccination | No |
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