NCT00092456

Brief Summary

This study was designed to evaluate consistency in the antibody response to three manufactured lots of an investigational Rotavirus Vaccine.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
793

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2003

Shorter than P25 for phase_3

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

May 1, 2003

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
2 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
6.5 years until next milestone

Results Posted

Study results publicly available

April 12, 2011

Completed
Last Updated

October 5, 2015

Status Verified

September 1, 2015

Enrollment Period

1.3 years

First QC Date

September 22, 2004

Results QC Date

June 19, 2009

Last Update Submit

September 18, 2015

Conditions

Rotavirus Infections

Outcome Measures

Primary Outcomes (1)

  • Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8]

    Antibody response to 3 manufactured lots of RotaTeq™ and placebo groups, based on the SNA PostDose 3 geometric mean titers (GMTs) (expressed in dilution units) against rotavirus serotypes G1, G2, G3, G4 and P1A\[8\]

    42 days following the 3rd vaccination

Other Outcomes (9)

  • Geometric Mean Antibody Titer(s) (GMT) to Serum Anti-rotavirus Immunoglobulin A (IgA).

    42 days following the 3rd vaccination

  • Number of Subjects With Clinical Adverse Experiences (CAEs)

    Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first

  • Number of Subjects With Serious Clinical Adverse Experiences (SCAEs)

    Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first

  • +6 more other outcomes

Study Arms (4)

RotaTeq™ Lot 1

EXPERIMENTAL

\~8.81 X 10\^7 IU/Dose of RotaTeq™

Biological: rotavirus vaccine, live, oral, pentavalent

RotaTeq™ Lot 2

EXPERIMENTAL

\~8.01 X 10\^7 IU/Dose of RotaTeq™

Biological: rotavirus vaccine, live, oral, pentavalent

RotaTeq™ Lot 3

EXPERIMENTAL

\~6.91 X 10\^7 IU/Dose of RotaTeq™

Biological: rotavirus vaccine, live, oral, pentavalent

Placebo

PLACEBO COMPARATOR
Biological: Placebo

Interventions

rotavirus vaccine, live, oral, pentavalentBIOLOGICAL

Three oral doses (\~8.81 X 10\^7 IU/Dose for Lot 1; \~8.01 X 10\^7 IU/Dose for Lot 2; and \~6.91 X 10\^7 IU/Dose for Lot 3) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination

Also known as: V260, RotaTeq™
RotaTeq™ Lot 1RotaTeq™ Lot 2RotaTeq™ Lot 3
PlaceboBIOLOGICAL

Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination

Placebo

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 the 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

MeSH Terms

Conditions

Rotavirus Infections

Interventions

Rotavirus VaccinesRotaTeq

Condition Hierarchy (Ancestors)

Reoviridae InfectionsRNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex 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

September 22, 2004

First Posted

September 27, 2004

Study Start

May 1, 2003

Primary Completion

August 1, 2004

Study Completion

August 1, 2004

Last Updated

October 5, 2015

Results First Posted

April 12, 2011

Record last verified: 2015-09