NCT00092443

Brief Summary

This study was designed to evaluate the safety of the investigational Rotavirus Vaccine and the efficacy to prevent Rotavirus Gastroenteritis.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,312

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2002

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2004

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 27, 2004

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

July 10, 2009

Completed
Last Updated

September 14, 2015

Status Verified

September 1, 2015

Enrollment Period

1.8 years

First QC Date

September 22, 2004

Results QC Date

May 19, 2009

Last Update Submit

September 11, 2015

Conditions

Rotavirus Infections

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Number of Subjects With ≥3 Fold Rise in Antibody Titer

    14 days following the 3rd vaccination

Study Arms (2)

RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose)

EXPERIMENTAL

Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart.

Biological: RotaTeq™, rotavirus vaccine, live, oral, pentavalent

Placebo matching RotaTeq™

PLACEBO COMPARATOR

Placebo matching RotaTeq™ administered 28 to 70 days apart.

Biological: Comparator: Placebo matching RotaTeq™

Interventions

RotaTeq™, rotavirus vaccine, live, oral, pentavalentBIOLOGICAL

Three doses of RotaTeq™ administered 28 to 70 days apart.

Also known as: V260
RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose)
Comparator: Placebo matching RotaTeq™BIOLOGICAL

Placebo matching RotaTeq™ administered 28 to 70 days apart.

Placebo matching RotaTeq™

Eligibility Criteria

Age6 Weeks - 12 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy infants

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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. doi: 10.1542/peds.2006-2058.

    PMID: 17200266BACKGROUND

MeSH Terms

Conditions

Rotavirus Infections

Interventions

RotaTeqRotavirus Vaccines

Condition Hierarchy (Ancestors)

Reoviridae InfectionsRNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Limitations and Caveats

Safety has been reported in the literature.

Results Point of Contact

Title
Vice President, Late Stage Development Group Leader
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

September 22, 2004

First Posted

September 27, 2004

Study Start

September 1, 2002

Primary Completion

June 1, 2004

Study Completion

June 1, 2004

Last Updated

September 14, 2015

Results First Posted

July 10, 2009

Record last verified: 2015-09