Evaluation of the Human Rotavirus Vaccine at Varying Schedules and Doses in Rural Ghana

PATH

Status and phase: Completed; Phase 4

Conditions: Rotavirus Gastroenteritis

Treatments: Biological: Human Rotavirus Vaccine

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01575197

GHANA-HRV-01

OPP1017334 (Other Grant/Funding Number)

Details and patient eligibility

About

The purpose of this study is to determine whether giving the Human Rotavirus Vaccine on alternate dosing schedules will enhance the immune response to the vaccine in a low-resource, high-burden country in Africa. Alternate dosing schedules studied include giving the 2-dose vaccine schedule at a slightly older age and giving an additional dose of the vaccine.

Enrollment: 456 patients

Sex: All

Ages: 42 to 55 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Between 42 and 55 days of age at the time of enrollment.
• Healthy infant free of chronic or serious medical condition as determined by history and physical examination at the time of study enrollment.
• Parents/guardians of each subject are able to understand and follow study procedures and agree to participate in the study by providing parental/guardian permission.

Exclusion criteria

• If child has previously had intussusception or abdominal surgery.
• Use of any immunosuppressive drugs or immunoglobulin and/or blood product use since birth or anticipated during study period.
• Current enrollment in any other intervention trial or use of any investigational drug or vaccine throughout the study period.
• Birthweight less than 2000 grams or gestation < 36 weeks, if this information is available.
• Any subject who reports plan to leave the study area before the completion of the study (i.e., relocation, migration, etc.).
• Another child living in the same compound is already enrolled in the trial (i.e., only one participant can be enrolled per compound).
• After the rotavirus vaccine is introduced into the routine EPI system in Navrongo: Another child in the compound is less than 16 weeks of age.
• The child has received rotavirus vaccine outside of this study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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456 participants in 3 patient groups

Rotavirus Vaccine at age 6 & 10 weeks

Active Comparator group

Description:

Participants are provided with the Human Rotavirus Vaccine (HRV) at 6 \& 10 weeks of age.

Treatment:

Biological: Human Rotavirus Vaccine

Rotavirus vaccine at age 10 & 14 weeks

Experimental group

Description:

Participants are provided with the Human Rotavirus Vaccine (HRV) at 10 \& 14 weeks of age.

Treatment:

Biological: Human Rotavirus Vaccine

Rotavirus vaccine at age 6,10,&14 weeks

Experimental group

Description:

Participants are provided with the Human Rotavirus Vaccine (HRV) at 6, 10, \& 14 weeks of age.

Treatment:

Biological: Human Rotavirus Vaccine