A randomized controlled trial of two versus three doses of Rotarix¿ vaccine for boosting and longevity of vaccine immune responses in Zambia

Not Applicable

• Conditions: Digestive System; Diarrhoea, Rotavirus

• Registration Number: PACTR201804003096919
• Lead Sponsor: Centre for Infectious Disease Research in Zambia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-16
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Other
• Sex: All
• Target Recruitment: 212

Inclusion Criteria

1. Mother willing to participate voluntarily and able to provide signed informed consent (with witness in the case of illiterate participant)

2. infant is eligible for rotavirus vaccine immunisation as per national policy (male or female, between 6 to 12 weeks old)

3. Mother willing to be physically examined, provide socio-demographic and medical data, blood at enrolment and breastmilk at scheduled visits.

4. Mother willing for infant to receive 2 or 3-dose Rotarix, saliva and stool sampling at enrolment , phlebotomy and enrolment, 14 weeks, 12 and 24 months and pre and 4 days post dose 1, 2 and 3

5. Mother willing to bring child to the clinic on scheduled dates, when infant has diarrhoea for collection of stool samples and plans to remain resident in the area

Exclusion Criteria

1. Contraindication to rotavirus vaccination

2. Previous administration of rotavirus vaccine to the infant

3. recent immunosuppressive therapy in child (including high-dose systemic corticosteroids)

4. History of ever receiving a blood transfusion or blood products, including immunoglobulins within the last 6 months for mother and child

5. Any condition deemed by the study investigator to pose potential harm to the participants or jeopardise the validity of study results

6. any existing congenital anomalies

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Boosting of rotavirus-specific immunoglobulin A antibody responses between infants receiving two versus three doses of Rotarix vaccine post dose 3 until 12 months of infant's age

Secondary Outcome Measures

Name	Time	Method
Safety of the 3-dose Rotarix vaccine regimen ;Longevity of rotavirus-specific immunoglobulin A antibody responses by the second year of life;Profile of infant pre-vaccination and vaccine induced innate and adaptive immune responses;Profile of infant histo-blood group antigen phenotypes and genotypes ;Profile of maternal breastmilk rotavirus specific immunoglobulins and innate anti-viral glycoproteins