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Status unknownNCT03367559Updated Mar 25, 2019

Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac® in Healthy Infants Aged Between 6-8 Weeks in Vietnam

A Phase 3 interventional study of ROTAVAC® in Rotavirus Infections, sponsored by Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products. Status unknown at 1 site in Vietnam. Open to participants aged 6 Weeks to 8 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-25.

Sponsored by Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products · Phase 3, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Enrolling by invitation — may be out of date.

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Phase
Phase 3
Study type
Interventional
Enrollment
360
Allocation
Not applicable
Ages
6 Weeks to 8 Weeks
Sex
All
01

Study summary

An open label study to evaluate immunogenicity, safety, and reactogenicity of Rotavac® (live attenuated oral rotavirus vaccine) as a 3-dose series in healthy infants aged between 6 weeks and 8 weeks in Vietnam.

02

Conditions studied

  • Rotavirus Infections

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Keywords

  • Rotavirus
  • ROTAVAC
  • Vaccine
  • Vietnam
03

In context

Rotavirus Infections

104 studies on the registry are indexed under Rotavirus Infections; 3 are open to participants now.

This study's planned enrollment of 360 is below the median of 403 across 69 interventional studies indexed under Rotavirus Infections.

Browse Rotavirus Infections studies →

Lead sponsor

Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Weeks to 8 Weeks
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy infants as established by medical history and clinical examination before entering the study.
  • Age: 6-8 weeks
  • Weight ≥ 2.5kg at birth.
  • Infants received EPI vaccines at birth (i.e., OPV, BCG and/or Hep B)
  • Parental ability and willingness to provide .
  • Parent who intends to remain in the area with the participant during the study period.

Exclusion criteria

Exclusion Criteria:

  • Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment (temporary exclusion).
  • Presence of fever (temperature ≥37.5oC) or hypothermia (temperature ≤35.5oC) on the day of enrollment (temporary exclusion).
  • Concurrent participation in another clinical trial.
  • Presence of significant malnutrition or any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, immunological, dermatological, neurological, cancer or disease) as determined by medical history and/or physical examination which would compromise the infant's health or is likely to result in non-conformance to the protocol.
  • History of congenital abdominal disorders, intussusception, abdominal surgery
  • Known or suspected impairment of immunological function based on medical history and physical examination.
  • Prior receipt of rotavirus vaccine.
  • A known sensitivity or allergy to any components of the study medication.
  • Major congenital or genetic defect.
  • Participant's parents not able, available or willing to accept active follow-up by the study staff.
  • Has received any immunoglobulin therapy and/or blood products since birth or planned administration during the study period.
  • History of chronic administration (defined as more than 14 days) of including . Infants on inhaled or topical steroids may be permitted to participate in the study.
  • History of any neurologic disorders or seizures.
  • Any medical condition in the parents/infants that, in the judgment of the investigator, would interfere with or serves as a to protocol adherence or a participant's parent's/legally acceptable representative's ability to give .
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
360 participants (estimated)

Study arms

  • Experimental
    Rotavirus Vaccine

    3 dose, interval for each dose is 4 weeks. The first dose will be received at 6-8 weeks of age.

    Biological: ROTAVAC®

Interventions

  • BiologicalROTAVAC®

    Rotavac® is in frozen form and is thawed till fully liquid prior to administration.

06

What researchers measure

Primary outcomes

  1. Frequency and rate of the AEs within 30 minutes after vaccination

    Frequency and rate of the adverse effects and severity of immediate adverse events (Local and General) within 30 minutes after vaccination

    Time frame: 30 minutes after vaccination

  2. Frequency and rate of the AEs within 7 days after vaccination

    Frequency and rate of adverse effects and severity of solicited adverse events (Local and General) within 7 days after each vaccination

    Time frame: for 7 days after each vaccination

  3. Frequency and rate of the AEs during 28 days after vaccination

    Frequency and rate of adverse effects and severity of unsolicited adverse events (Local and General) during 28 days after each vaccination

    Time frame: for 28 days after vaccination

  4. Frequency and rate of the SAEs during 28 days after vaccination

    Frequency and rate of adverse effects and severity of Serious Adverse Events (Local and General) during 28 days after each vaccination

    Time frame: for 28 days after vaccination

07

Study locations

1 site
  • Thai Binh Health Center
    Thái Bình, 410000, Vietnam
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2018 (actual). Primary completion is estimated for May 2019, 15 months after the start.

Of 14 phase 3 interventional studies under Rotavirus Infections, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 20. This study's planned 15 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 5, 2017
First posted
Dec 8, 2017
StartActual
Feb 8, 2018
Primary completionEst.
May 2019
CompletionEst.
May 2019
Last update
Mar 25, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03367559
Lead sponsor
Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products
Collaborators
Bharat Biotech International Limited
Responsible party
Pham Ngoc Hung, MD PhD Assoc (Principal Investigator, Vietnam Military Medical University) — Principal investigator
First posted
Dec 8, 2017
Start date
Feb 8, 2018
Primary completion
May 2019 (estimated)
Completion
May 2019 (estimated)
Last update
Mar 25, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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