Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in INDIA (PROVIDE)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

372 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-01

Study Completion Date

2016-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Oral polio and rotavirus vaccines are significantly less effective in children living in the developing world. Tropical enteropathy, which is associated with intestinal inflammation, decreased absorption and increased permeability, may contribute substantially to oral vaccine failure in developing country settings. Other possible causes of oral vaccine underperformance include malnutrition, interference with maternal or breast milk antibodies, changes in gut microbiota, and genetic susceptibility.The primary Objective of this study is to determine whether decreased vaccine responsiveness to oral poliovirus or rotavirus vaccines is associated with the presence of tropical enteropathy.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in Bangladesh

NCT01375647

Rotavirus Diarrhea Vaccine Virus Shedding Tropical Enteropathy

COMPLETED PHASE3

Improving Rotavirus Vaccine Immune Response

NCT01825109

Healthy Infants Mothers

COMPLETED PHASE3

Fractional Inactivated Poliovirus Vaccine Booster and Rotavirus Study

NCT02847026

Poliomyelitis

COMPLETED PHASE4

Pilot Study of the Rotavirus Vaccine in Infants With Intestinal Failure

NCT00995813

Intestinal Failure Rotavirus Vaccines

COMPLETED PHASE4

Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants (V260-014)(COMPLETED)

NCT00130832

Rotavirus Infections Gastroenteritis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Intervention of this study is to vaccinate oral poliovirus vaccine and oral rotavirus vaccine to the child with two group; with inactivated poliovirus vaccine and without inactivated poliovirus vaccine. Rotavirus vaccines give to the child at 10 weeks of age and 17 weeks of age.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Poliomyelitis Tropical Enteropathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

IPV vaccination

Randomized IPV vaccination to children at the age of 39 weeks.

Group Type EXPERIMENTAL

IPV vaccination

Intervention Type BIOLOGICAL

Randomized IPV or OPV to children aged at 39weeks.

OPV vaccination

Randomized OPV vaccination to children at the age of 39 weeks.

Group Type PLACEBO_COMPARATOR

IPV vaccination

Intervention Type BIOLOGICAL

Randomized IPV or OPV to children aged at 39weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IPV vaccination

Randomized IPV or OPV to children aged at 39weeks.

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Rotavirus vaccination to children at 10 and 17 weeks of age.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Mother willing to sign informed consent form.
2. Infant aged 0 to 49 days old.
3. No obvious congenital abnormalities or birth defects.

Exclusion Criteria

1. Parents are not willing to have child's blood drawn.
2. Parents are planning to enroll child into another clinical study during the time period of this trial.
3. Mother not willing to have blood drawn and breast milk extracted.
4. Parents not willing to have field research assistant in home.
5. History of seizures or other apparent neurologic disorders.
6. Infant does not have proof of BCG and OPV since birth by immunization card.
7. History of acute illness and/or immunocompromised state of the child.
8. Immunocompromised or chronically ill mother

Minimum Eligible Age

42 Days

Maximum Eligible Age

49 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes