Clinical trial NCT00092456: Consistency Lots Vaccine Study (V260-009)
Official title: Comparison of the Immunogenicity and Safety of Three Consistency Lots of V260 in Healthy Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rotavirus Infections
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2004-09-27
Enrollment: 793
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility 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.

Primary outcomes:
measure: Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8]
timeFrame: 42 days following the 3rd vaccination
Secondary outcomes:
Other outcomes:
measure: Geometric Mean Antibody Titer(s) (GMT) to Serum Anti-rotavirus Immunoglobulin A (IgA).
timeFrame: 42 days following the 3rd vaccination
measure: Number of Subjects With Clinical Adverse Experiences (CAEs)
timeFrame: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first
measure: Number of Subjects With Serious Clinical Adverse Experiences (SCAEs)
timeFrame: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first
measure: Number of Subjects With Vaccine-Related Clinical AEs (CAEs)
timeFrame: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first
measure: Number of Subjects With Serious Vaccine-Related Clinical AEs (CAEs)
timeFrame: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first
measure: Number of Subjects Discontinued Due to Clinical Adverse Experiences
timeFrame: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first
measure: Number of Subjects Discontinued Due to Vaccine-Related Clinical Adverse Experiences (CAEs)
timeFrame: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first
measure: Number of Subjects Discontinued Due to Serious Clinical Adverse Experiences (SCAEs)
timeFrame: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first
measure: Number of Subjects Discontinued Due to Serious Vaccine-related Clinical Adverse Experiences (CAEs)
timeFrame: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: