Safety and Immunogenicity of Rotavirus (Bio Farma) Vaccine in Adults, Children & Neonates

Phase 1

Completed

• Conditions: Safety Issues

• Registration Number: NCT03462108
• Lead Sponsor: PT Bio Farma

Brief Summary

This study is to assess the safety of Rotavirus (Bio Farma) vaccine in adults, children and neonates.

Detailed Description

To describe the safety of this vaccine after each immunization. To assess preliminary information of immunogenicity following Rotavirus (Bio Farma) vaccine immunization.

Study Timeline

• Study First Submitted: 2017-09-29
• Study First Submitted QC: 2018-03-08
• Study First Posted: 2018-03-12
• Status Verified: 2018-04
• Study Start: 2018-04-09
• Primary Completion: 2019-02-18
• Study Completion: 2019-03-30
• Last Update Submitted: 2019-04-01
• Last Update Posted: 2019-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Solicited symptoms after each immunization	0-7 days	Number of subjects with solicited systemic and gastrointestinal symptoms in the day 0-7 following each dose of investigational product

Secondary Outcome Measures

Name	Time	Method
Serious adverse events of Rotavirus (Bio Farma) vaccine	28 days	Number and percentage of subjects with Serious Adverse Events (SAE) within 28 days after each dose of investigational product
Adverse events of Rotavirus (Bio Farma) vaccine compare to placebo in neonates group	28 days	Number and percentage of subject with adverse event (AE) within 28 days after each dose of investigational product compare to placebo (in neonates group)
Serious adverse events of Rotavirus (Bio Farma) vaccine compare to placebo in neonates group	28 days	Number and percentage of subject with Serious Adverse Events (SAE) within 28 days after each dose of investigational product compare to placebo (in neonates group)
Serum neutralizing antibody (SNA) following immunization	4-6 weeks after last immunization	Serum neutralizing antibody (SNA) before and after last immunization
Adverse events of Rotavirus (Bio Farma) vaccine	28 days	Number and percentage of subjects with unsolicited Adverse Events (AE) in the day 0-28 following each dose of investigational product
Number of subject who has abnormality value of routine hematology and biochemical evaluation that probably related to the vaccination	7 days	Deviation in routine hematology and biochemical evaluation
Excretion of rotavirus in stools in neonates group	3-7 days	Number of neonates with rotavirus excretion in stools
Number of subjects with >=3 times increasing antibody from baseline to post investigational product dosing	4-6 weeks after last immunization	Subjects with \>=3 times increasing antibody from baseline to post investigational product dosing
Serum anti-rotavirus immunoglobulin (Ig)A following immunization	4-6 weeks after last immunization	Serum anti-rotavirus immunoglobulin (Ig)A before and after last immunization
Geometric Mean Titer (GMT) following immunization	4-6 weeks after last immunization	Geometric mean titer (GMT) before and after last immunization

Trial Locations

Locations (4)

Gantiwarno Primary Health Center; 🇮🇩 Klaten, Central Java, Indonesia

Klaten Selatan Primary Health Center; 🇮🇩 Klaten, Central Java, Indonesia

Ngawen Primary Health Center; 🇮🇩 Klaten, Central Java, Indonesia

RS Soeradji Tritonegoro; 🇮🇩 Klaten, Central Java, Indonesia