Consistency Lots Vaccine Study (V260-009)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Rotavirus Infections

Treatments: Biological: rotavirus vaccine, live, oral, pentavalent; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00092456

2004_078

V260-009

Details and patient eligibility

About

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

Enrollment: 793 patients

Sex: All

Ages: 6 to 12 weeks old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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793 participants in 4 patient groups, including a placebo group

RotaTeq™ Lot 1

Experimental group

Description:

\~8.81 X 10\^7 IU/Dose of RotaTeq™

Treatment:

Biological: rotavirus vaccine, live, oral, pentavalent

RotaTeq™ Lot 2

Experimental group

Description:

\~8.01 X 10\^7 IU/Dose of RotaTeq™

Treatment:

Biological: rotavirus vaccine, live, oral, pentavalent

RotaTeq™ Lot 3

Experimental group

Description:

\~6.91 X 10\^7 IU/Dose of RotaTeq™

Treatment:

Biological: rotavirus vaccine, live, oral, pentavalent

Placebo

Placebo Comparator group

Treatment:

Biological: Placebo