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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02286895
• Date of registration: 01/10/2014
• Prospective Registration: Yes
• Primary sponsor: PATH
• Public title: Immune Response to Rotavirus Vaccine After a Supplemental Dose Given at 9 Months of Age With Local EPI Vaccines in Mali
• Scientific 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
• Date of first enrolment: October 2014
• Target sample size: 600
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02286895
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Mali

Contacts

• Name: Samba O Sow, MD, Msc
• Affiliation: Center for Vaccine Development - Mali

Key inclusion & exclusion criteria

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 to
the administration of study vaccines or planned administration during the vaccine
period.

- Chronic administration (defined as more than 14 days) of immunosuppressants or other
immune-modifying agents since birth (including systemic corticosteroids, this means
prednisone, or equivalent, =0.5 mg/kg/day; topical steroids including inhaled steroids
are allowed).

- A family history of congenital or hereditary immunodeficiency.

- History of intussusception.

- Uncorrected congenital malformation of the gastrointestinal tract that would
predispose for intussusception.

- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal
functional abnormality, as determined by medical history or physical examination,
which in the opinion of the investigator, might interfere with the study objectives.

- Acute illness at the time of enrollment (acute disease is defined as the presence of a
moderate or severe illness with fever [axillary temperature =38°C] or without fever
[severity determined at the discretion of the investigator]. Acute illness is a
temporary exclusion.

- Any condition or criterion that in the opinion of the investigator might compromise
the well-being of the subject or the compliance with study procedures or interfere
with the outcome of the study.



Age minimum: 9 Months
Age maximum: 11 Months
Gender: All

Health Condition(s) or Problem(s) studied

Diarrhea Rotavirus

Intervention(s)

Biological: meningitis conjugate vaccine (PsA-TT-5µg)

Biological: measles vaccine (MV)

Biological: pentavalent rotavirus vaccine (PRV)

Biological: yellow fever vaccine (YFV)

Primary Outcome(s)

Number/Percentage of Subjects With Seroconversion for Anti-measles Immunoglobulin G (IgG) Antibody [Time Frame: 28 days post-vaccination]

Number/Percentage of Subjects With Seroresponses for Yellow Fever Neutralizing Antibody [Time Frame: 28 days post-vaccination]

Secondary Outcome(s)

Number of Solicited Adverse Reactions (AR) Experienced by Participants [Time Frame: 7 days post-vaccination]

Geometric Mean of Anti-rotavirus IgG Among Subjects With <20 Units/mL Concentration at Baseline [Time Frame: 28 days post-vaccination]

Number/Percentage of Subjects With Anti-rotavirus IgA <20 Units/mL at Baseline Visit That Had >=20 Units/mL at Day 28 [Time Frame: 28 days post-vaccination]

Number/Percentage of Subjects With Seroconversion for Anti-measles Immunoglobulin G (IgG) Antibody [Time Frame: 3 months post-vaccination]

Number/Percentage of Subjects With Anti-rotavirus IgA Titer of =20 Units/mL [Time Frame: 28 days post-vaccination]

Number/Percentage of Participants Experiencing Immediate Reactions Post-vaccination [Time Frame: Within 30 minutes post-vaccination]

Number/Percentage of Subjects With Anti-rotavirus IgG Titer at Least 3 Times Baseline Value [Time Frame: 28 days post-vaccination]

Geometric Mean of Anti-rotavirus IgG Concentration [Time Frame: 28 days post-vaccination]

Serum Neutralization Geometric Mean Titers for Yellow Fever Vaccine [Time Frame: 28 days post-vaccination]

Geometric Mean of Anti-rotavirus IgA Concentration [Time Frame: 28 days post-vaccination]

Geometric Mean of Meningitis Serum Bactericidal Antibody Titer [Time Frame: Baseline to Day 28]

Number/Percentage of Participants Experiencing Serious Adverse Events (SAE) [Time Frame: 3 months post-vaccination]

Number/Percentage of Subjects With Anti-rotavirus IgG <20 Units/mL at Baseline Visit That Had >=20 Units/mL at Day 28 [Time Frame: 28 days post-vaccination]

Number/Percentage of Subjects With Seroresponses for Meningitis Conjugate Serum Bactericidal Antibody (SBA) [Time Frame: 28 days post-vaccination]

Number/Percentage of Subjects With Anti-rotavirus Immunoglobulin A (IgA) Titer at Least 3 Times Baseline Value [Time Frame: 28 days post-vaccination]

Geometric Mean of Anti-rotavirus IgA Among Subjects With <20 Units/mL Concentration at Baseline [Time Frame: 28 days post-vaccination]

Number/Percentage of Subjects With Anti-rotavirus IgG Titer of =20 Units/mL [Time Frame: 28 days post-vaccination]

Secondary ID(s)

PATH-RVI-PRV-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Maryland, College Park

Center for Vaccine Development - Mali

Results

• Results available: Yes
• Date Posted: 07/12/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02286895