Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00439660
Status:
COMPLETED
Last Update Posted:
2021-02-23
First Post:
2007-02-23
Brief Title:
Dose Escalation Study to Evaluate Oral Rotavirus Vaccine 116E Live Attenuated in Healthy Infants 8 to 20 Weeks Old
Sponsor:
Bharat Biotech International Limited
Organization:
Bharat Biotech International Limited
Study Overview
Official Title:
Double-Blind Randomized Placebo-Controlled Dose Escalating Phase IbIIa Study to Evaluate the Safety and Immunogenicity of Live Attenuated Oral Rotavirus Vaccine 116E in Healthy Non-Malnourished Infants 8 to 20 Weeks of Age
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 ie1040 1050 and 1060 FFU and for three administrations of each of these dosages given to infants at 4-week intervals 180 infants 90 vaccinees90 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
Detailed Description:
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 vaccineplacebo 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 vaccineplacebo 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 vaccineplacebo 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 vaccineplacebo will be at 12 and 16 weeks of age and the same strategy will be followed for each of the three dosages The study vaccineplacebo 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 vaccineplacebo 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 vaccineplacebo 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 vaccineplacebo of the lowest dosage 1040 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 1050 and the strategy listed above will be repeated for a total of 180 enrolled infants 90 vaccinees90 placebo The DSMB will again meet to review the data available from this cohort ie 1050 and the team will proceed to screen infants for the next higher dosage 1060 only if the former is declared safe
At the end of the study ie 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
All screened infants will be offered EPI vaccines as scheduled The second and third administration of study vaccineplacebo will be at 12 and 16 weeks of age and the same strategy will be followed for each of the three dosages The study vaccineplacebo 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 vaccineplacebo 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 vaccineplacebo 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 vaccineplacebo of the lowest dosage 1040 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 1050 and the strategy listed above will be repeated for a total of 180 enrolled infants 90 vaccinees90 placebo The DSMB will again meet to review the data available from this cohort ie 1050 and the team will proceed to screen infants for the next higher dosage 1060 only if the former is declared safe
At the end of the study ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISRCTN57452882 | REGISTRY | ISRCTN | None |