Consistency Lots Vaccine Study (V260-009)

Rotavirus Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00092456
• Other study ID #: V260-009
• Secondary ID: 2004_078
• Status: Completed
• Phase: Phase 3
• First received: September 22, 2004
• Last updated: September 18, 2015
• Start date: May 2003
• Est. completion date: August 2004

Study information

• Verified date: September 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 793
• Est. completion date: August 2004
• Est. primary completion date: August 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Weeks to 12 Weeks

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Rotavirus Infections

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Geometric Mean Antibody Titer(s) (GMT) to Serum Anti-rotavirus Immunoglobulin A (IgA).	Post Dose 3 serum samples were assayed for serum anti-rotavirus IgA	42 days following the 3rd vaccination	No
Other	Number of Subjects With Clinical Adverse Experiences (CAEs)	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	Yes
Other	Number of Subjects With Serious Clinical Adverse Experiences (SCAEs)	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	Yes
Other	Number of Subjects With Vaccine-Related Clinical AEs (CAEs)	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	Yes
Other	Number of Subjects With Serious Vaccine-Related Clinical AEs (CAEs)	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	Yes
Other	Number of Subjects Discontinued Due to Clinical Adverse Experiences	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	Yes
Other	Number of Subjects Discontinued Due to Vaccine-Related Clinical Adverse Experiences (CAEs)	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	Yes
Other	Number of Subjects Discontinued Due to Serious Clinical Adverse Experiences (SCAEs)	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	No
Other	Number of Subjects Discontinued Due to Serious Vaccine-related Clinical Adverse Experiences (CAEs)	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	No
Primary	Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8]	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	No