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Safety and Immunogenicity Study of the Recombinant Human Bovine Reassortant Rotavirus Vaccine in Healthy Indian Infants

Primary Purpose

Rotavirus Infections

Status
Withdrawn
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV]
Placebo
Sponsored by
Shantha Biotechnics Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rotavirus Infections

Eligibility Criteria

6 Weeks - 8 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy infants 6-8 weeks of age of either sex;
  • Born after a gestational period of 36-42 weeks with birth weight >2 kg;
  • Father, mother or other legally acceptable representative (guardian) properly informed about the study and having signed the informed consent form (ICF);
  • Parent or guardian available for the entire period of the study and reachable by study staff for post-vaccination follow-up.

Exclusion Criteria:

  • History of congenital abdominal disorders, intussusception, or abdominal surgery;
  • Known or suspected impairment of immunological function;
  • Known hypersensitivity to any component of the rotavirus vaccine;
  • Prior receipt of any rotavirus vaccine;
  • Fever, with an oral temperature ≥38.1oC (≥100.5oF); presumably measured by study staff?
  • History of known rotavirus disease, chronic diarrhea, or failure to thrive;
  • Baseline level of ALT or AST >2.5 times the upper limit of normal;
  • Clinical evidence of active gastrointestinal illness (infants with GERD can participate in the study so long as this condition is well controlled with or without medication);
  • Receipt of any IM, oral, or IV corticosteroid treatment (infants on inhaled steroids may be permitted to participate in the study);
  • Infants residing in a household with an immuno-compromised person (e.g., individuals with a congenital immunodeficiency, HIV infection, leukemia, lymphoma, Hodgkin's disease, multiple myeloma, generalized malignancy, chronic renal failure, nephrotic syndrome, organ or bone marrow transplantation, or those receiving immunosuppressive chemotherapy including long-term systemic corticosteroids);
  • Infants testing positive for HBV, HCV, or HIV infection;
  • Prior receipt of a blood transfusion or blood products, including immunoglobulins;
  • Any infants who can not be adequately followed for safety by telephone and/or a home visit;
  • Any conditions which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

Sites / Locations

  • Christian Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Safety and tolerability

Secondary Outcome Measures

Immunogenicity
Viral Shedding

Full Information

First Posted
September 22, 2008
Last Updated
February 2, 2010
Sponsor
Shantha Biotechnics Limited
Collaborators
PATH
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1. Study Identification

Unique Protocol Identification Number
NCT00757926
Brief Title
Safety and Immunogenicity Study of the Recombinant Human Bovine Reassortant Rotavirus Vaccine in Healthy Indian Infants
Official Title
Phase I/II, Randomized, Double-blind, Placebo-controlled, Staged Dosage Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 3-dose Series of Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV] Administered to Healthy Indian Infants Concurrently With Other Standard EPI Vaccines
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Withdrawn
Why Stopped
Replaced with an alternate study
Study Start Date
September 2009 (undefined)
Primary Completion Date
August 2010 (Anticipated)
Study Completion Date
September 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Shantha Biotechnics Limited
Collaborators
PATH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A randomized, double-blind, placebo-controlled, staged dosage escalation study to evaluate the safety, tolerability, and immunogenicity of a 3-dose series of Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV] administered to healthy Indian infants concurrently with other standard EPI vaccines would be undertaken to evaluate the study hypothesis that a 3-dose series of BRV-TV (containing the VP7 serotypes G1, G2, G3, and G4) administered orally to healthy Indian infants at 6-8, 10-12, and 14-16 weeks of age concurrently with other standard EPI vaccines would be generally well tolerated and immunogenic.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotavirus Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV]
Intervention Description
Three oral doses of the vaccine (0.5 ml each) following oral administration of antacid.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Three oral doses of the placebo (0.5 ml each)following oral administration of antacid.
Primary Outcome Measure Information:
Title
Safety and tolerability
Time Frame
Upto one month after each of the three doses of vaccine/ placebo
Secondary Outcome Measure Information:
Title
Immunogenicity
Time Frame
At one month after each of the three doses of vaccine/ placebo
Title
Viral Shedding
Time Frame
After each of the three doses of the vaccine/placebo

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
8 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy infants 6-8 weeks of age of either sex; Born after a gestational period of 36-42 weeks with birth weight >2 kg; Father, mother or other legally acceptable representative (guardian) properly informed about the study and having signed the informed consent form (ICF); Parent or guardian available for the entire period of the study and reachable by study staff for post-vaccination follow-up. Exclusion Criteria: History of congenital abdominal disorders, intussusception, or abdominal surgery; Known or suspected impairment of immunological function; Known hypersensitivity to any component of the rotavirus vaccine; Prior receipt of any rotavirus vaccine; Fever, with an oral temperature ≥38.1oC (≥100.5oF); presumably measured by study staff? History of known rotavirus disease, chronic diarrhea, or failure to thrive; Baseline level of ALT or AST >2.5 times the upper limit of normal; Clinical evidence of active gastrointestinal illness (infants with GERD can participate in the study so long as this condition is well controlled with or without medication); Receipt of any IM, oral, or IV corticosteroid treatment (infants on inhaled steroids may be permitted to participate in the study); Infants residing in a household with an immuno-compromised person (e.g., individuals with a congenital immunodeficiency, HIV infection, leukemia, lymphoma, Hodgkin's disease, multiple myeloma, generalized malignancy, chronic renal failure, nephrotic syndrome, organ or bone marrow transplantation, or those receiving immunosuppressive chemotherapy including long-term systemic corticosteroids); Infants testing positive for HBV, HCV, or HIV infection; Prior receipt of a blood transfusion or blood products, including immunoglobulins; Any infants who can not be adequately followed for safety by telephone and/or a home visit; Any conditions which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raman Rao, MD
Organizational Affiliation
Shantha Biotechnics Limited
Official's Role
Study Director
Facility Information:
Facility Name
Christian Medical College
City
Vellore
State/Province
Tamil Nadu
ZIP/Postal Code
632004
Country
India

12. IPD Sharing Statement

Learn more about this trial

Safety and Immunogenicity Study of the Recombinant Human Bovine Reassortant Rotavirus Vaccine in Healthy Indian Infants

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