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Consistency Lots Vaccine Study (V260-009)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00092456
First received: September 22, 2004
Last updated: March 11, 2011
Last verified: March 2011
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Merck:

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]


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

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Vice President of Late Stage Development, 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: March 11, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on June 17, 2013