Safety and Immunogenicity Study of the Tetravalent Rotavirus Vaccine

Rotavirus Gastroenteritis Clinical Trial

Official title:

Phase I/II, Randomized, Double-blind, Placebo-controlled, Dosage Selection (10e5.5 or 10e6.25 FFU of Each Constituent Serotype Per 0.5 mL) 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01061658
• Other study ID #: SBL/BRV-TV/Form1/PhI/2009/0100
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: February 2, 2010
• Last updated: October 1, 2010
• Start date: July 2010
• Est. completion date: December 2010

Study information

• Verified date: October 2010
• Source: Shantha Biotechnics Limited
• Contact: Mandeep S Dhingra, MD
• Phone: +914066301000
• Email: drmandeep[@]shanthabiotech.co.in
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Weeks to 8 Weeks

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Gastroenteritis
• Rotavirus Gastroenteritis

Intervention

Biological:
• Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine
Higher dosage of vaccine
• Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine
Lower dosage of vaccine

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
India	Christian Medical College	Vellore	Tamilnadu

Sponsors (1)

Lead Sponsor	Collaborator
Shantha Biotechnics Limited

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The frequency, severity, and causality of Reactogenicity Events and other Adverse Events.		After each dose and upto 28 days after third dose	Yes
Secondary	The Seroconversion rate, Sero-response rate and the GMT of serum IgA antibody against rotavirus.		After each dose and upto 28 days after third dose	No
Secondary	The frequency and duration of post-vaccination shedding of vaccine rotavirus in stool samples		After each dose and upto 7 days after third dose	No