Phase III Placebo-controlled Study of V260 (RotaTeq™) in Japanese Healthy Infants (V260-029)(COMPLETED)

NCT00718237 | Completed Phase 3 Results

• 2 other identifiers: V260-0292008_014
• Study Type: interventional
• Target: 762
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to evaluate whether V260 is effective and well tolerated in Japanese healthy infants.

Conditions

Rotavirus; Gastroenteritis

Keywords

Gastroenteritis; Rotavirus

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Rotavirus Gastroenteritis of Any Severity Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A

  Any severity cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1A occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition

  At least 14 days following the 3rd vaccination

Secondary Outcomes (2)

• Number of Participants With Moderate to Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A

  At least 14 days following the 3rd vaccination

• Number of Participants With Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A

  At least 14 days following the 3rd vaccination

Study Arms (2)

1

EXPERIMENTAL

RotaTeq™

Biological: Rotavirus Vaccine, Live, Oral, Pentavalent (V260, RotaTeq™)

2

PLACEBO COMPARATOR

Placebo

Biological: Comparator: Comparator: Placebo (unspecified)

Interventions

Rotavirus Vaccine, Live, Oral, Pentavalent (V260, RotaTeq™) BIOLOGICAL

Rotateq orally administered 3 times

Also known as: RotaTeq™, V260

1

Comparator: Comparator: Placebo (unspecified) BIOLOGICAL

Placebo orally administered 3 times

2

Eligibility Criteria

• Age: 6 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy Japanese Infants, 6 Weeks Through 12 Weeks Of Age

You may not qualify if:

• History Of Known Prior Rotavirus Gastroenteritis
• Subjects Who Are Concurrently Participating In Or Are Anticipated To Participate In Other Studies Of Investigational Products At Any Time During The Study Period

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Iwata S, Nakata S, Ukae S, Koizumi Y, Morita Y, Kuroki H, Tanaka Y, Shizuya T, Schodel F, Brown ML, Lawrence J. Efficacy and safety of pentavalent rotavirus vaccine in Japan: a randomized, double-blind, placebo-controlled, multicenter trial. Hum Vaccin Immunother. 2013 Aug;9(8):1626-33. doi: 10.4161/hv.24846. Epub 2013 May 31.

  PMID: 23732903 RESULT

MeSH Terms

Conditions

Gastroenteritis

Interventions

Rotavirus Vaccines; RotaTeq

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2008
• First Posted: July 18, 2008
• Study Start: August 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: April 13, 2017
• Results First Posted: July 23, 2010

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share