Advertisement

Topics

Safety and Immunogenicity Study of the Tetravalent Rotavirus Vaccine

2014-07-24 14:10:07 | BioPortfolio

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.

Study Design

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

Conditions

Rotavirus Gastroenteritis

Intervention

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

Location

Christian Medical College
Vellore
Tamilnadu
India
632002

Status

Not yet recruiting

Source

Shantha Biotechnics Limited

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:10:07-0400

Clinical Trials [2348 Associated Clinical Trials listed on BioPortfolio]

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

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 (G...

Study of 2 Doses of Oral Live Attenuated Human Rotavirus (HRV) Vaccine for the Prophylaxis of Rotavirus Gastroenteritis

Rotavirus (RV) is the most important cause of acute gastroenteritis (GE) requiring the hospitalization of infants and young children in developed and developing countries and can be a freq...

Study of Immunogenicity & Safety of 2 Different Formulations of Human Rotavirus (HRV) Vaccine for the Prophylaxis of Rotavirus Gastroenteritis

Rotavirus (RV) is the most important cause of acute gastroenteritis (GE) requiring the hospitalization of infants and young children in developed and developing countries and can be a freq...

A Study to Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants.

The main objectives of this study are to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until two years ...

A Phase II Trial of a WRAIR Live Attenuated Virus Tetravalent Dengue Vaccine in Healthy US Adults

This descriptive study will evaluate the safety and immunogenicity of 3 different formulations of the WRAIR dengue vaccine compared to a placebo.

PubMed Articles [13683 Associated PubMed Articles listed on BioPortfolio]

Replication and Excretion of the Live Attenuated Tetravalent Dengue Vaccine CYD-TDV in a Flavivirus-Naive Adult Population: Assessment of Vaccine Viremia and Virus Shedding.

We assessed replication and excretion of the live attenuated tetravalent dengue vaccine (CYD-TDV) into biological fluids following vaccination in dengue-naive adults in Australia.

Dependency of Vaccine Efficacy on Pre-Exposure and Age: A Closer Look at a Tetravalent Dengue Vaccine.

A recombinant, live-attenuated, tetravalent dengue vaccine (CYD-TDV) was licensed for children of 9 years old or older in a few countries, but the dependence of vaccine efficacy on baseline immunity s...

Effectiveness of a live oral human rotavirus vaccine after programmatic introduction in Bangladesh: A cluster-randomized trial.

Rotavirus vaccines are now globally recommended by the World Health Organization (WHO), but in early 2009 WHO's Strategic Advisory Group of Experts on Immunization reviewed available data and conclude...

Five-year antibody persistence in children after one dose of inactivated or live attenuated hepatitis A vaccine.

In China, both inactivated hepatitis A (HA) vaccine and live attenuated HA vaccine are available. We conducted a trial to evaluate 5-year immune persistence induced by one dose of inactivated or live ...

Revaccination of Guinea Pigs With the Live Attenuated Mycobacterium tuberculosis Vaccine MTBVAC Improves BCG's Protection Against Tuberculosis.

The need for an effective vaccine against human tuberculosis has driven the development of different candidates and vaccination strategies. Novel live attenuated vaccines are being developed that prom...

Medical and Biotech [MESH] Definitions

A live attenuated virus vaccine of chick embryo origin, used for routine immunization of children and for immunization of adolescents and adults who have not had mumps or been immunized with live mumps vaccine. Children are usually immunized with measles-mumps-rubella combination vaccine.

A live attenuated virus vaccine of chick embryo origin, used for routine immunization of children and for immunization of adolescents and adults who have not had measles or been immunized with live measles vaccine and have no serum antibodies against measles. Children are usually immunized with measles-mumps-rubella combination vaccine. (From Dorland, 28th ed)

A live attenuated virus vaccine of duck embryo or human diploid cell tissue culture origin, used for routine immunization of children and for immunization of nonpregnant adolescent and adult females of childbearing age who are unimmunized and do not have serum antibodies to rubella. Children are usually immunized with measles-mumps-rubella combination vaccine. (Dorland, 28th ed)

A live, attenuated varicella virus vaccine used for immunization against chickenpox. It is recommended for children between the ages of 12 months and 13 years.

A live vaccine containing attenuated poliovirus, types I, II, and III, grown in monkey kidney cell tissue culture, used for routine immunization of children against polio. This vaccine induces long-lasting intestinal and humoral immunity. Killed vaccine induces only humoral immunity. Oral poliovirus vaccine should not be administered to immunocompromised individuals or their household contacts. (Dorland, 28th ed)

More From BioPortfolio on "Safety and Immunogenicity Study of the Tetravalent Rotavirus Vaccine"

Quick Search
Advertisement
 

Relevant Topic

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...


Searches Linking to this Trial