Diarrhea Rotavirus Clinical Trial
Official title:
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
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.
Vaccination is the best way to prevent severe rotavirus disease and the deadly, dehydrating
diarrhea that it causes. However, given only moderate efficacy in the first year of life and
a possible further decline in immunity, it is considered a top priority by public health
experts to evaluate the possible value of a "booster" dose of rotavirus vaccine in low income
countries to confer longer duration of protection into the second year of life when disease
burden continues to be high.
This study is an open-label, individual-randomized, parallel-group, comparative
immunogenicity trial. Participating infants randomized to Group A will receive one dose each
of measles vaccine (MV), yellow fever vaccine (YFV), and meningitis conjugate vaccine
(PsA-TT-5μg) at 9 months of age, and infants randomized to Group B will receive one dose each
of MV, YFV, PsA-TT-5μg, and PRV at 9 months of age.
The study will simultaneously evaluate two primary objectives, one for noninferiority of the
response to MV given with PRV (co-primary objective 1) and one for noninferiority of the
response to YFV given with PRV (co-primary objective 2).
Secondary objectives of the study were the following:
1. To evaluate the non-inferiority of the immune response 3 months post-vaccination (as
sero-conversion) to MV given with PRV (Group B) to that given without PRV (Group A).
2. To compare the immune response (as geometric mean titers [GMTs]) to YFV given with PRV
(Group B) to that given without PRV (Group A).
3. To evaluate the non-inferiority of the immune response (as sero-response) to PsA-TT-5μg
given with PRV (Group B) compared to that given without PRV (Group A).
4. To compare the immune response (as GMTs) to PsA-TT-5μg given with PRV (Group B) to that
given without PRV (Group A).
5. To evaluate the superiority of the immune response (as sero-response and geometric mean
concentrations [GMCs]) to a supplemental dose of PRV given at 9 months of age with local
EPI vaccines (Group B) compared no supplemental dose (Group A).
6. To describe the safety profile of study vaccination with PRV.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03703336 -
Phase III Study of Liquid Formulation of ROTAVIN
|
Phase 3 | |
Completed |
NCT03602053 -
Study of BBIL's ROTAVAC® and ROTAVAC 5CM Vaccines in Zambia
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT04658914 -
Human Challenge With Live-attenuated Rotavirus to Assess Next-generation Rotavirus Vaccines in Africa
|
Phase 2 |