OTHER NCT03462108.

Trial name or title	"Safety and Immunogenicity of Rotavirus (Bio Farma) Vaccine in Adults, Children & Neonates"
Methods	Phase 1, mixed methods study; double‐blind, randomized study (neonates); open‐label study (adults and children)
Participants	Number: 100 Description: Adults, children and neonates
Interventions	1. Rotavirus (Bio Farma) Vaccine 2. Placebo
Outcomes	1. Solicited symptoms 2. Adverse events 3. Serious adverse events 4. Number of infants who have abnormality value of routine haematology and biochemical evaluation that probably related to the vaccination 5. Excretion of rotavirus in stools in neonates group 6. Number of infants with ≥ 3 times increasing antibody from baseline to post‐investigational product dosing 7. Serum anti‐rotavirus immunoglobulin (Ig)A 8. Serum neutralizing antibody 9. Geometric mean titre
Starting date	April 2018 Completion: December 2018 (estimated)
Contact information	Novilia Sjafri Bachtiar; novilia@biofarma.co.id
Notes	Location: Indonesia Registration number: NCT03462108 Source of funding: PT Bio Farma