V260 Registration Study (V260-013)(COMPLETED)

Rotavirus Clinical Trial

Official title:

Immunogenicity and Safety of V260 in Healthy Infants in Korea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00166517
• Other study ID #: V260-013
• Secondary ID: 2005_071
• Status: Completed
• Phase: Phase 3
• First received: September 9, 2005
• Last updated: March 12, 2015
• Start date: August 2005
• Est. completion date: July 2006

Study information

• Verified date: March 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

Immunogenicity and Safety of V260 in Healthy Infants in Korea

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Weeks to 12 Weeks

Eligibility

Inclusion Criteria:

• At first study vaccination, age 6 weeks through exactly 12 weeks

Exclusion Criteria:

• History of congenital abdominal disorders, intussusception, or abdominal surgery

• History of known prior rotavirus disease

• Ongoing chronic diarrhea or failure to thrive

• Clinical evidence of active gastrointestinal illness

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Rotavirus

Intervention

Biological:
• Rotavirus Vaccine, Live, Oral, Pentavalent
3 doses of rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 70 days post Dose 1, and 28 to 70 days post Dose 2
• Comparator: Placebo
3 doses of placebo to rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 70 days post Dose 1, and 28 to 70 days post Dose 2

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Kim DS, Lee TJ, Kang JH, Kim JH, Lee JH, Ma SH, Kim SY, Kim HM, Shin SM. Immunogenicity and safety of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine in healthy infants in Korea. Pediatr Infect Dis J. 2008 Feb;27(2):177-8. doi: 10.1097/INF. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Anti-Rotavirus IgA Response	Number of subjects with = 3-fold rise from baseline (Predose 1) in; Serum IgA 14 days Postdose 3	Baseline and 14 days Postdose 3	No
Secondary	Serum Neutralizing Antibody (SNA) Response to Serotypes G1, G2, G3, G4 and P1A	Number of subjects with = 3-fold rise from baseline (Predose 1) in; SNA response to G1, G2, G3, G4 and P1A 14 days Postdose 3	Baseline and 14 days Postdose 3	No

External Links

•   MedWatch - FDA maintained medical product safety Information
•   Merck: Patient & Caregiver U.S. Product Web Site