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Safety and Immunogenicity Study of the Tetravalent Rotavirus Vaccine

NCT ID: NCT01061658

Last Updated: 2010-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2010-12-31

Brief Summary

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A double blind placebo controlled Phase I/II study to evaluate the safety and immunogenicity of the Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine \[BRV-TV\]in Indian infants. The study would be carried out in 90 healthy infants. Three doses of the rotavirus vaccine or placebo would be administered orally to each infant at 6-8, 10-12 and 14-16 weeks of age. The rotavirus vaccine would be administered at one of the two planned virus concentrations (10e5.5 or 10e6.25 FFU of each constituent serotype per 0.5 ml). Each administration of the vaccine/placebo would be preceded by oral administration of 2.0 mL of antacid.

Detailed Description

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Conditions

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Rotavirus Gastroenteritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Vaccine - High dosage

Group Type EXPERIMENTAL

Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine

Intervention Type BIOLOGICAL

Higher dosage of vaccine

Vaccine - Lower dosage

Group Type EXPERIMENTAL

Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine

Intervention Type BIOLOGICAL

Lower dosage of vaccine

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Interventions

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Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine

Higher dosage of vaccine

Intervention Type BIOLOGICAL

Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine

Lower dosage of vaccine

Intervention Type BIOLOGICAL

Placebo

Placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy infants 6-8 weeks of age at time of enrollment 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). In case of father, mother or other legally acceptable representative (guardian) being unable to read or write, having had the ICF explained to them in the presence of a study independent witness and the witness having signed the 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 axillary temperature ≥38.1oC (≥100.5oF); 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 in the past 30 days (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 suspected to be HIV, HBV or HCV positive from the available clinical history or born to mothers known to be HIV, HBV or HCV positive.
* Prior receipt of a blood transfusion or blood products, including immunoglobulins;
* Any infants who cannot be adequately followed for safety by a home visit;
* Any conditions which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
* Parent/s or guardian of subject unable to maintain diary card
Minimum Eligible Age

6 Weeks

Maximum Eligible Age

8 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shantha Biotechnics Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Shantha Biotechnics Limited, Hyderabad, India

Principal Investigators

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Raman Rao, MD

Role: STUDY_DIRECTOR

Shantha Biotechnics Limited

Locations

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Christian Medical College

Vellore, Tamil Nadu, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Mandeep S Dhingra, MD

Role: CONTACT

[email protected]
+914066301000 ext. 1801

Facility Contacts

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Gagandeep Kang, MD PhD

Role: primary

[email protected]
+914162282052

Other Identifiers

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SBL/BRV-TV/Form1/PhI/2009/0100

Identifier Type: -

Identifier Source: org_study_id