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: September 5, 2014
Last verified: September 2014

September 22, 2004
September 5, 2014
May 2003
August 2004   (final data collection date for primary outcome measure)
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]
Not Provided
Complete list of historical versions of study NCT00092456 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
  • 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.
Not Provided
 
Consistency Lots Vaccine Study (V260-009)
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Rotavirus Infections
  • 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™
  • 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™
    Intervention: Biological: rotavirus vaccine, live, oral, pentavalent
  • Experimental: RotaTeq™ Lot 2
    ~8.01 X 10^7 IU/Dose of RotaTeq™
    Intervention: Biological: rotavirus vaccine, live, oral, pentavalent
  • Experimental: RotaTeq™ Lot 3
    ~6.91 X 10^7 IU/Dose of RotaTeq™
    Intervention: Biological: rotavirus vaccine, live, oral, pentavalent
  • Placebo Comparator: Placebo
    Intervention: Biological: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
793
September 2004
August 2004   (final data collection date for primary outcome measure)

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.
Both
6 Weeks to 12 Weeks
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00092456
V260-009, 2004_078
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP