Phase 3 Completed N=178 Randomized Double-blind Prevention

V260 Registration Study (V260-013)(COMPLETED)

rotavirus

Source: ClinicalTrials.gov NCT00166517 ↗

Enrolled (actual)

178

Serious AEs

7.3%

Results posted

Sep 2009

Primary outcomePrimary: Serum Anti-Rotavirus IgA Response — 89; 7 Participants — p=0.003

Summary

Immunogenicity and Safety of V260 in Healthy Infants in Korea

Outcome Measures

Outcome	Result	p-value
PRIMARY Serum Anti-Rotavirus IgA Response	89; 7	0.003 sig
SECONDARY Serum Neutralizing Antibody (SNA) Response to Serotypes G1, G2, G3, G4 and P1A	67; 2; 34; 1; 42; 1	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00166517). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.