UnknownPhase 1

Safety and Preliminary Immunogenicity Study of Inactivated Vaccine for Prevention of Rotavirus Infection

China32 participantsStarted 2020-12-03

Plain-language summary

This study is a randomized, double-blinded, placebo-controlled, Phase 1, dose-escalation study to evaluate the safety, reactogenicity and immunogenicity of Inactivated Rotavirus Vaccine (IRV) performed in healthy adult (aged 18-49 years), adolescent (aged 6-17 years) and infant subjects (aged 2-71 months). Primary objectives of the clinical trial include assessing the safety and tolerability of IRV given at two and three dose levels and comparing the safety and tolerability of IRV after each vaccination, between dosage groups, and by pre-vaccination rotavirus immune status. Secondary objective of the clinical trial is immunogenicity evaluation after each vaccination, between dosage groups, and by pre-vaccination rotavirus immune status.

Who can participate

Age range2 Months – 49 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 2 months old to 49 years old, healthy resident, excluding the following:
✓. I and/or my guardian voluntarily participate and sign an informed consent form, and can follow the requirements of the clinical trial protocol;
✓. Have never received oral rotavirus live attenuated vaccine.

Exclusion criteria

✕. Armpit temperature \>37.0℃ before vaccination；
✕. Subjects with history of intussusception or suffering from intussusception；
✕. Subjects with history of convulsions and convulsions; history of epilepsy, mental illness and their family history；
✕. Subjects with history of allergy to vaccination；
✕. Acute attacks of various acute diseases (fever) or chronic diseases within 3 days before receiving the study vaccine；
✕. Subjects receiving immune enhancement or immunosuppressive therapy within 3 months (continuous oral or infusion for more than 14 days)；

What they're measuring

Safety index-incidence of adverse reactions/events

Timeframe: 0-30 minutes after the first dose vaccination

Safety index-incidence of adverse reactions/events

Timeframe: 0-30 minutes after the second dose vaccination

Safety index-incidence of adverse reactions/events

Timeframe: 0-30 minutes after the third dose vaccination

Safety index-incidence of abnormal blood biochemistry assessment

Timeframe: Day 4 after the first dose vaccination

Safety index-incidence of abnormal blood routine assessment

Timeframe: Day 4 after the first dose vaccination

Safety index-incidence of abnormal urine routine assessment

Timeframe: Day 4 after the first dose vaccination

Safety index-incidence of abnormal blood biochemistry assessment

Timeframe: Day 4 after the second dose vaccination

Safety index-incidence of abnormal blood routine assessment

Trial details

NCT IDNCT04626856

SponsorChinese Academy of Medical Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-06

View on ClinicalTrials.gov More Rotavirus Infection trials

Plain-language summary

Who can participate

Age range2 Months – 49 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 2 months old to 49 years old, healthy resident, excluding the following:
✓. I and/or my guardian voluntarily participate and sign an informed consent form, and can follow the requirements of the clinical trial protocol;
✓. Have never received oral rotavirus live attenuated vaccine.

Exclusion criteria

✕. Armpit temperature \>37.0℃ before vaccination；
✕. Subjects with history of intussusception or suffering from intussusception；
✕. Subjects with history of convulsions and convulsions; history of epilepsy, mental illness and their family history；
✕. Subjects with history of allergy to vaccination；
✕. Acute attacks of various acute diseases (fever) or chronic diseases within 3 days before receiving the study vaccine；
✕. Subjects receiving immune enhancement or immunosuppressive therapy within 3 months (continuous oral or infusion for more than 14 days)；

What they're measuring

Safety index-incidence of adverse reactions/events

Timeframe: 0-30 minutes after the first dose vaccination

Safety index-incidence of adverse reactions/events

Timeframe: 0-30 minutes after the second dose vaccination

Safety index-incidence of adverse reactions/events

Timeframe: 0-30 minutes after the third dose vaccination

Safety index-incidence of abnormal blood biochemistry assessment

Timeframe: Day 4 after the first dose vaccination

Safety index-incidence of abnormal blood routine assessment

Timeframe: Day 4 after the first dose vaccination

Safety index-incidence of abnormal urine routine assessment

Timeframe: Day 4 after the first dose vaccination

Safety index-incidence of abnormal blood biochemistry assessment

Timeframe: Day 4 after the second dose vaccination

Safety index-incidence of abnormal blood routine assessment