NCT Number: NCT00092456
This study was designed to evaluate consistency in the antibody response to three manufactured lots of an investigational Rotavirus Vaccine.
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All sexes
Interventional
Phase 3
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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-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
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]
Time frame: 42 days following the 3rd vaccination
Post Dose 3 serum samples were assayed for serum anti-rotavirus IgA
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
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.
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.
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
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.
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.
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.
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.
Merck Sharp & Dohme LLC
Industry
Comparison of the Immunogenicity and Safety of Three Consistency Lots of V260 in Healthy Infants
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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