Clinical trial NCT03367559: Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac® in Healthy Infants Aged Between 6-8 Weeks in Vietnam
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Rotavirus Infections
Keywords: Rotavirus
ROTAVAC
Vaccine
Vietnam
Lead sponsor: Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products
Sponsor class: OTHER
Collaborators: name: Bharat Biotech International Limited
First posted: 2017-12-08
Enrollment: 360
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Frequency and rate of the AEs within 30 minutes after vaccination
timeFrame: 30 minutes after vaccination
measure: Frequency and rate of the AEs within 7 days after vaccination
timeFrame: for 7 days after each vaccination
measure: Frequency and rate of the AEs during 28 days after vaccination
timeFrame: for 28 days after vaccination
measure: Frequency and rate of the SAEs during 28 days after vaccination
timeFrame: for 28 days after vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Thái Bình
country: Vietnam
facility: Thai Binh Health Center
Study officials:
References: