Who is sponsoring NCT02286895?

NCT02286895 is sponsored by PATH.

What condition does NCT02286895 study?

NCT02286895 studies Diarrhea Rotavirus.

What drugs are being tested in NCT02286895?

Interventions: pentavalent rotavirus vaccine (PRV), measles vaccine (MV), yellow fever vaccine (YFV), meningitis conjugate vaccine (PsA-TT-5μg).

What is the status of NCT02286895?

NCT02286895 is currently COMPLETED.

Last reviewed 2018-12-10 · How we verify

An Evaluation of the Immune Response to Pentavalent Rotavirus Vaccine After a Supplemental Dose Given at 9 Months of Age With Local EPI Vaccines in Mali

NCT02286895 Phase 4 COMPLETED Results posted

This study is an evaluation of the immune response to pentavalent rotavirus vaccine (PRV) after an additional fourth dose is given at 9 months of age with local World Health Organization (WHO) Expanded Programme on Immunization (EPI) vaccines in Mali.

Details

Lead sponsor	PATH
Phase	Phase 4
Status	COMPLETED
Enrolment	600
Start date	2014-10
Completion	2015-03

Conditions

Diarrhea Rotavirus

Interventions

pentavalent rotavirus vaccine (PRV)
measles vaccine (MV)
yellow fever vaccine (YFV)
meningitis conjugate vaccine (PsA-TT-5μg)

Primary outcomes

Number/Percentage of Subjects With Seroconversion for Anti-measles Immunoglobulin G (IgG) Antibody — 28 days post-vaccination
Measured using a commercially-available Enzyme Linked Immunosorbent Assay (ELISA). Seroconversion was defined as a measurement ≥1.10 geometric mean titer (GMT) at Day 28 among subjects with measurement ≤0.90 at baseline
Number/Percentage of Subjects With Seroresponses for Yellow Fever Neutralizing Antibody — 28 days post-vaccination
Measured by virus neutralization assay, determined using Robert Koch Institute's yellow fever standard of practice and relative to international scientific references for which the level of anti-YF neutralizing IgG protection was known. Seroresponse was defined as a geometric mean titer (GMT) of at least four times baseline value.

Countries

Mali