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

NCT ID: NCT01575197

Last Updated: 2015-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 456 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2013-02-28

Brief Summary

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.

Conditions

Rotavirus Gastroenteritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Rotavirus Vaccine at age 6 & 10 weeks

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

Group Type: ACTIVE_COMPARATOR

Human Rotavirus Vaccine

Intervention Type: BIOLOGICAL

Rotavirus vaccine will be administered concomitantly with other routine Expanded Programme on Immunization (EPI) vaccinations at 6 \& 10 weeks of age, 10 \& 14 weeks of age, or 6, 10, \& 14 weeks of age, depending on study arm assignment.

Rotavirus vaccine at age 10 & 14 weeks

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

Group Type: EXPERIMENTAL

Human Rotavirus Vaccine

Intervention Type: BIOLOGICAL

Rotavirus vaccine will be administered concomitantly with other routine Expanded Programme on Immunization (EPI) vaccinations at 6 \& 10 weeks of age, 10 \& 14 weeks of age, or 6, 10, \& 14 weeks of age, depending on study arm assignment.

Rotavirus vaccine at age 6,10,&14 weeks

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

Group Type: EXPERIMENTAL

Human Rotavirus Vaccine

Intervention Type: BIOLOGICAL

Rotavirus vaccine will be administered concomitantly with other routine Expanded Programme on Immunization (EPI) vaccinations at 6 \& 10 weeks of age, 10 \& 14 weeks of age, or 6, 10, \& 14 weeks of age, depending on study arm assignment.

Interventions

Human Rotavirus Vaccine

Rotavirus vaccine will be administered concomitantly with other routine Expanded Programme on Immunization (EPI) vaccinations at 6 \& 10 weeks of age, 10 \& 14 weeks of age, or 6, 10, \& 14 weeks of age, depending on study arm assignment.

Intervention Type: BIOLOGICAL

Other Intervention Names

Rotarix

Eligibility Criteria

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.

• Minimum Eligible Age: 42 Days
• Maximum Eligible Age: 55 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Noguchi Memorial Institute for Medical Research

OTHER

Sponsor Role: collaborator

Navrongo Health Research Center

UNKNOWN

Sponsor Role: collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

PATH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

George Armah, PhD

Role: PRINCIPAL_INVESTIGATOR

Noguchi Memorial Institute for Medical Research

Locations

Navrongo Health Research Center

Navrongo, Upper East Region, Ghana

Countries

Ghana

References

Armah G, Lewis KD, Cortese MM, Parashar UD, Ansah A, Gazley L, Victor JC, McNeal MM, Binka F, Steele AD. A Randomized, Controlled Trial of the Impact of Alternative Dosing Schedules on the Immune Response to Human Rotavirus Vaccine in Rural Ghanaian Infants. J Infect Dis. 2016 Jun 1;213(11):1678-85. doi: 10.1093/infdis/jiw023. Epub 2016 Jan 27.

Reference Type: DERIVED

PMID: 26823335 (View on PubMed)

Other Identifiers

OPP1017334

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

GHANA-HRV-01

Identifier Type: -

Identifier Source: org_study_id