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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03367559
• Date of registration: 05/12/2017
• Prospective Registration: Yes
• Primary sponsor: Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products
• Public title: Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac® in Healthy Infants Aged Between 6-8 Weeks in Vietnam
• Scientific title: An Open Label Study to Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac® (Live Attenuated Rotavirus Vaccine) as a 3-dose Series in Healthy Infants Aged Between 6 Weeks and 8 Weeks in Vietnam
• Date of first enrolment: February 8, 2018
• Target sample size: 360
• Recruitment status: Enrolling by invitation
• URL: https://clinicaltrials.gov/show/NCT03367559
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Vietnam

Key inclusion & exclusion criteria

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 informed consent.

- Parent who intends to remain in the area with the participant during the study period.

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 autoimmune 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 immunosuppressants
including corticosteroids. 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 contraindication to protocol
adherence or a participant's parent's/legally acceptable representative's ability to
give informed consent.



Age minimum: 6 Weeks
Age maximum: 8 Weeks
Gender: All

Health Condition(s) or Problem(s) studied

Rotavirus Infections

Intervention(s)

Biological: ROTAVAC®

Primary Outcome(s)

Frequency and rate of the AEs within 7 days after vaccination [Time Frame: for 7 days after each vaccination]

Frequency and rate of the SAEs during 28 days after vaccination [Time Frame: for 28 days after vaccination]

Frequency and rate of the AEs during 28 days after vaccination [Time Frame: for 28 days after vaccination]

Frequency and rate of the AEs within 30 minutes after vaccination [Time Frame: 30 minutes after vaccination]

Secondary ID(s)

VX-2017.01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bharat Biotech International Limited