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OpenTrials
Completed

NCT Number: NCT00166517

V260 Registration Study (V260-013)(COMPLETED)

Immunogenicity and Safety of V260 in Healthy Infants in Korea

Completed

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Key information

Conditions

Rotavirus

Age range

6 week–12 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rotavirus Vaccine, Live, Oral, Pentavalent

Biological

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

Biological

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

Primary outcomes

  1. Serum Anti-Rotavirus IgA Response

    Time frame: Baseline and 14 days Postdose 3

    Number of subjects with ≥ 3-fold rise from baseline (Predose 1) in

    Serum IgA 14 days Postdose 3

Secondary outcomes

  1. Serum Neutralizing Antibody (SNA) Response to Serotypes G1, G2, G3, G4 and P1A

    Time frame: Baseline and 14 days Postdose 3

    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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Immunogenicity and Safety of V260 in Healthy Infants in Korea

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 14, 2005
Registry last updated
Apr 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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