Consistency Lots Vaccine Study (V260-009)

September 18, 2015 updated by: Merck Sharp & Dohme LLC

Comparison of the Immunogenicity and Safety of Three Consistency Lots of V260 in Healthy Infants

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

793

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 2 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy infants

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Biological: Placebo

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
Experimental: RotaTeq™ Lot 1
~8.81 X 10^7 IU/Dose of RotaTeq™
Biological: rotavirus vaccine, live, oral, pentavalent
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
Other Names:
  • V260
  • RotaTeq™
Experimental: RotaTeq™ Lot 2
~8.01 X 10^7 IU/Dose of RotaTeq™
Biological: rotavirus vaccine, live, oral, pentavalent
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
Other Names:
  • V260
  • RotaTeq™
Experimental: RotaTeq™ Lot 3
~6.91 X 10^7 IU/Dose of RotaTeq™
Biological: rotavirus vaccine, live, oral, pentavalent
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
Other Names:
  • V260
  • RotaTeq™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8]
Time Frame: 42 days following the 3rd vaccination
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Geometric Mean Antibody Titer(s) (GMT) to Serum Anti-rotavirus Immunoglobulin A (IgA).
Time Frame: 42 days following the 3rd vaccination
Post Dose 3 serum samples were assayed for serum anti-rotavirus IgA
42 days following the 3rd vaccination
Number of Subjects With Clinical Adverse Experiences (CAEs)
Time Frame: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first
Subjects in this study were followed for all CAEs, including intussusception. A CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
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)
Time Frame: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first
Subjects were followed for all SCAEs. SCAEs are any CAEs occurring at any dose that: results in death; or is life threatening; or results in persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose.
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 Vaccine-Related Clinical AEs (CAEs)
Time Frame: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first
CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product. Vaccine-related CAEs are CAEs that are assessed by an investigator, who is a qualified physician, as being related to the vaccine according to his/her best clinical judgment.
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 Vaccine-Related Clinical AEs (CAEs)
Time Frame: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first
Serious vaccine-related CAEs are CAEs assessed by an investigator as being related to the vaccine that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose
Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first
Number of Subjects Discontinued Due to Clinical Adverse Experiences
Time Frame: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first
A CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.
Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first
Number of Subjects Discontinued Due to Vaccine-Related Clinical Adverse Experiences (CAEs)
Time Frame: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first
CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product. Vaccine-related CAEs are CAEs that are assessed by an investigator who is a qualified physician as being related to the vaccine according to his/her best clinical judgment.
Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first
Number of Subjects Discontinued Due to Serious Clinical Adverse Experiences (SCAEs)
Time Frame: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first
SCAEs are any CAEs that: results in death; or is life threatening; or results in persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose.
Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first
Number of Subjects Discontinued Due to Serious Vaccine-related Clinical Adverse Experiences (CAEs)
Time Frame: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first
Serious vaccine-related CAEs are CAEs assessed by an investigator as being related to the vaccine that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose.
Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Primary Completion (Actual)

August 1, 2004

Study Completion (Actual)

August 1, 2004

Study Registration Dates

First Submitted

September 22, 2004

First Submitted That Met QC Criteria

September 24, 2004

First Posted (Estimate)

September 27, 2004

Study Record Updates

Last Update Posted (Estimate)

October 5, 2015

Last Update Submitted That Met QC Criteria

September 18, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V260-009
  • 2004_078

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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