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

Rotavirus Infections Clinical Trial

Official 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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03367559
• Other study ID #: VX-2017.01
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: February 8, 2018
• Est. completion date: May 2019

Study information

• Verified date: March 2019
• Source: Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 360
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks to 8 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Rotavirus Infections

Intervention

Biological:
• ROTAVAC®
Rotavac® is in frozen form and is thawed till fully liquid prior to administration.

Locations

Country	Name	City	State
Vietnam	Thai Binh Health Center	Thái Bình

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products	Bharat Biotech International Limited

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 minutes after vaccination
Primary	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	for 7 days after each vaccination
Primary	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	for 28 days after vaccination
Primary	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	for 28 days after vaccination