Track topics on Twitter Track topics that are important to you
This study will be a Phase I, randomized, double blind, safety and immunogenicity trial of the Vero cell based 116E neonatal rotavirus vaccine candidate strain in healthy non-malnourished infants aged 8-20 weeks at three different dosage levels i.e.10^4.0, 10^5.0 and 10^6.0 FFU and for three administrations of each of these dosages given to infants at 4-week intervals. 180 infants (90 vaccinees/90 placebo) will be enrolled for each of the three dosage levels. The progression from the lower to the next higher dosage will be based on approval by the Data Safety Monitoring Board (DSMB) to be constituted by the Department of Biotechnology, New Delhi.
Infants will be identified through a community survey in urban neighborhoods in the city of Delhi, India and screened at 6 weeks of age if parental consent is available. They will be given the first dose of EPI vaccines at this age. Of those screened, eligible infants will be given the first administration of the test vaccine/placebo at 8 weeks of age if they meet the enrollment inclusion criteria, and consent is available. The safety profile will be studied through daily home visits for 14 days post administration. Stool specimens will be collected before vaccination (day 0) and on days 3, 7 and 28 post administration of vaccine/placebo. Subsequently, two contacts will be made; a home visit on day 21 and a clinic visit on day 28. On the day 28 visit, a stool and blood specimen will be collected. Prior to each administration of vaccine/placebo the infants will be assessed for any contraindications.
All screened infants will be offered EPI vaccines as scheduled. The second and third administration of study vaccine/placebo will be at 12 and 16 weeks of age and the same strategy will be followed for each of the three dosages The study vaccine/placebo are not being administered with the EPI vaccines even though in the future rotavirus vaccine and the EPI vaccines may be coadministered. For the purpose of this study this schedule is being adopted, as no data are available on the interaction of EPI vaccines with this rotavirus vaccine candidate.
Baseline sera will be collected at 6 weeks (at the time of screening) and again 4 weeks after administration of the vaccine/placebo in a randomly selected subsample after the first (60 infants), second (60 infants) and third (60 infants) administration of each dosage.
Clinical adverse events will be monitored and relatedness to vaccine/placebo administration assessed for 14 days after each administration of the dosage under study, whereas monitoring for symptoms of intussusception will be assessed throughout the 28 day follow up period. Laboratory adverse events will be monitored for upto 28 days after first administration of each dosage. After the 4 week follow up of the third administration of the vaccine/placebo of the lowest dosage (10^4.0) is completed for all enrolled infants and the data safety monitoring board (DSMB) meeting will be convened and the data from the study will be analyzed, the code broken. If the DSMB declares the dosage safe, guided by the apriori criteria, the team will move on to screening infants for the next higher dosage (10^5.0) and the strategy listed above will be repeated for a total of 180 enrolled infants (90 vaccinees/90 placebo). The DSMB will again meet to review the data available from this cohort (i.e. 10^5.0) and the team will proceed to screen infants for the next higher dosage (10^6.0) only if the former is declared safe.
At the end of the study i.e. after the last visit of the last participant, based on reactogenicity and immunogenicity profile of each dosage, the appropriate dosage will be selected for further clinical evaluation.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Oral Rotavirus Vaccine 116E Live Attenuated
Society for Applied Studies (SAS)
Active, not recruiting
Bharat Biotech International Limited
Published on BioPortfolio: 2014-07-23T21:30:05-0400
It has been observed that in children who get a severe rotavirus infection, subsequent infections cause either no symptoms or generally only mild or moderate diarrhea. This evidence is t...
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]i...
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...
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 ...
The main objectives of this study is to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until one year of...
A Phase 4, multicentre, randomized, single-blind clinical trial to evaluate the immunogenicity of the live, attenuated, oral rotavirus vaccine (116E), ROTAVAC®, administered simultaneously with or without the buffering agent in healthy infants in India.
The World Health Organization recommends that rotavirus vaccines should be included in all national immunization programs. Some currently licensed oral rotavirus vaccines contain a buffering agent (ei...
Rotavirus vaccination was introduced in the United States in 2006. Our objectives were to examine reductions in diarrhea-associated health care utilization after rotavirus vaccine implementation and t...
Low efficacy of rotavirus (RV) vaccines in developing African and Asian countries, where malnutrition is prevalent, remains a major concern and a challenge for global health.
Monovalent rotavirus vaccine (RV1) was introduced in Tanzania in January 2013 under the Reach Every Child initiative, to be given at ages 6 and 10 weeks. We used the sentinel hospital rotavirus surv...
Rotavirus is the most common nonseasonal vaccine preventable illness. Despite increased severity of rotaviral illness in early infancy, most neonatal intensive care units (NICU) do not administer rota...
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)
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 varicella virus vaccine used for immunization against chickenpox. It is recommended for children between the ages of 12 months and 13 years.
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)
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...
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...