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Consistency Lots Vaccine Study (V260-009)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092456
First received: September 22, 2004
Last updated: October 30, 2014
Last verified: October 2014
  Purpose

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


Condition Intervention Phase
Rotavirus Infections
Biological: rotavirus vaccine, live, oral, pentavalent
Biological: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Comparison of the Immunogenicity and Safety of Three Consistency Lots of V260 in Healthy Infants

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8] [ Time Frame: 42 days following the 3rd vaccination ] [ Designated as safety issue: No ]
    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]


Other Outcome Measures:
  • Geometric Mean Antibody Titer(s) (GMT) to Serum Anti-rotavirus Immunoglobulin A (IgA). [ Time Frame: 42 days following the 3rd vaccination ] [ Designated as safety issue: No ]
    Post Dose 3 serum samples were assayed for serum anti-rotavirus IgA

  • 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 ] [ Designated as safety issue: Yes ]
    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

  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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

  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 793
Study Start Date: May 2003
Study Completion Date: September 2004
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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™
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


  Eligibility

Ages Eligible for Study:   6 Weeks to 12 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092456

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092456     History of Changes
Other Study ID Numbers: V260-009, 2004_078
Study First Received: September 22, 2004
Results First Received: June 19, 2009
Last Updated: October 30, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rotavirus Infections
RNA Virus Infections
Reoviridae Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014