Immune Response to Rotavirus Vaccine After a Supplemental Dose Given at 9 Months of Age With Loca… (NCT02286895) | Clinical Trial Compass
CompletedPhase 4
Immune Response to Rotavirus Vaccine After a Supplemental Dose Given at 9 Months of Age With Local EPI Vaccines in Mali
Mali600 participantsStarted 2014-10
Plain-language summary
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.
Who can participate
Age range9 Months – 11 Months
SexALL
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Inclusion Criteria:
* At least 9 months of age through 11 months of age (has not yet reached 1st birthday) at the time of administration of study vaccines.
* Residence in the study area.
* At least one parent or guardian who is at least 18 years of age and is willing to provide written informed consent.
* Generally healthy and free of obvious health problems as established by medical history including physical examination and clinical judgment of the investigator.
* A child who is fully vaccinated according to the local EPI schedule (exclusive of oral polio vaccine birth dose).
* A parent or guardian is willing to attend all planned study visits or allow home visits and mobile phone contacts, as required by the protocol.
Exclusion Criteria:
* Previous receipt any measles-containing vaccine.
* Previous receipt of any yellow fever vaccine.
* Previous receipt of any meningitis vaccine.
* Receipt of rotavirus vaccine within the past 90 days.
* Administration of any other vaccine within 8 weeks prior to administration of study vaccines or planned vaccination during the 4 weeks after study vaccination.
* History of allergic disease or known hypersensitivity to any component of the study vaccines and/or following administration of vaccines included in the local program of immunization
* Use of any investigational or non-registered drug within 90 days prior to the administration of study vaccines.
* Administration of immunoglobulins and/or any blood products within 90 days prior t…
What they're measuring
1
Number/Percentage of Subjects With Seroconversion for Anti-measles Immunoglobulin G (IgG) Antibody
Timeframe: 28 days post-vaccination
2
Number/Percentage of Subjects With Seroresponses for Yellow Fever Neutralizing Antibody