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Clinical Trials/CTRI/2019/02/017774
CTRI/2019/02/017774CompletedPhase 3

A Phase 3, Multicenter, Open-Label, Randomized Clinical Trial to evaluate Safety and Immunogenicity of ROTAVAC® -20�C and Rotavac 5CM administered at Birth (Neonatal Schedule) and Additional Dose versus Infant Schedule against Rotavirus Gastroenteritis

Bharat Biotech International Limited0 sites408 target enrollmentStarted: TBDLast updated:
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Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
408
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Inclusion Criteria

  • •1 Healthy male or female full term (>=36 weeks gestation) babies weighing at least 2500g
  • •at birth. Healthiness established by medical history and clinical examination
  • •2 Resident of a state in India where ROTAVAC® is not introduced as a part of UIP
  • •3 Subjects whose either of parent or guardian is able to understand planned study
  • •procedures and demonstrate comprehension of the protocol procedures prior to
  • •vaccination.
  • •4 Subjects whose parent or guardian, in the opinion of the investigator, can and will
  • •comply with the requirements of the protocol (eg completion of the diary cards, return
  • •for follow-up visits).
  • •5 Written informed consent obtained from the subjects parent or guardian prior to
  • •performance of any study specific procedure.
  • •6 Generally healthy subjects without acute or chronic, clinically significant pulmonary,
  • •cardiovascular, hepatic or renal functional abnormality, as determined by physical
  • •examination.
  • •7 Infants receiving vaccines as per Universal Immunization Program of India
  • •8 Subjects with no history of rotavirus vaccination prior to study enrolment and whose
  • •parent or guardian is willing to forego any outside rotavirus vaccination during the
  • •entire study period.
  • •9 Subjects with a minor illness [such as low-grade fever between 36.5°C (97.7°F) and
  • •37.5°C (99.5°F) and mild upper respiratory infection] may be enrolled at the discretion
  • •of the investigator.

Exclusion Criteria

  • •1 Use of any investigational or non-registered product (drug or vaccine) other than the
  • •study vaccines during the study period
  • •2 Concurrently participating in another clinical study, at any time during the study
  • •period, in which the subject has been or will be exposed to an investigational or a
  • •non-investigational vaccine/product (pharmaceutical product or device).
  • •3 Administration of long-acting immune-modifying drugs (e.g. infliximab, rituximab)
  • •since birth or planned administration any time during the study period.
  • •4 Any confirmed or suspected immunosuppressive or immunodeficient condition,
  • •based on medical history and physical examination (e.g. Severe Combined
  • •Immunodeficiency Disease).
  • •5 Neonates born to mother Infected with Human Immunodeficiency Virus (HIV)
  • •regardless of clinical stage of immunodeficiency.
  • •6 History of or current autoimmune disease.
  • •7 Administration of immunoglobulins and/or any blood products since birth or planned
  • •administration during the study period
  • •8 History of uncorrected congenital malformation of the gastrointestinal tract.
  • •9 History of intussusception.
  • •10 History of any reaction or hypersensitivity likely to be exacerbated by any component
  • •of the vaccines.
  • •11 Hypersensitivity to latex.
  • •12 Presence of significant malnutrition or any systemic disorder (cardiovascular,
  • •pulmonary, hepatic, renal, gastrointestinal, haematological, endocrine,
  • •immunological, dermatological, neurological, cancer or autoimmune disease) as
  • •determined by medical history and/or physical examination which would compromise
  • •the childâ??s health or is likely to result in non-conformance to the protocol.
  • •13 Acute disease and/or fever at the time of enrolment.
  • •a Fever is defined as temperature >=38.0°C/100.4°F. The preferred location for
  • •measuring temperature in this study will be underarm (axillary) temperature
  • •first. If that reading is >99ï?°F, take rectal temperature for a more precise and
  • •accurate result
  • •b Subjects with acute diarrhea and/or vomiting within last 24 hours
  • •14 Have signs or symptoms that could confound or confuse assessment of study
  • •vaccine reactogenicity
  • •15 Any medical condition in the parents/ infant which, in the judgment of the
  • •Investigator, would interfere with or serves as a contraindication to protocol

Investigators

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Rotavac@Birth Phase 3 clinical trial | Clinical Trial