Phase 3, Randomized, Multi-Centric, Open-labeled Study to Evaluate Immunogenicity and Safety of BBV154 Booster Dose in Participants Previously Vaccinated With EUA Vaccines
Sponsor study identifier
interventional
875
1 country
9
Study Start
February 26, 2022
Actual (reported)Primary Completion
May 3, 2022
Actual (reported)Study Completion
September 28, 2022
Actual (reported)A total sample size of 875 healthy volunteers ages ≥18 years will be recruited in this study in the ratio of 2:1:2:1:1. Group 1: (BBV154 in COVAXIN recipients): In this group, 250 participants will be recruited and administered with a booster dose of BBV154 vaccine in form of drops (0.5 mL) via intranasal route, in individuals previously vaccinated with COVAXIN. Group 2: (BBV152(COVAXIN) in COVAXIN recipients): In this group, 125 participants will be recruited and administered with a booster dose of BBV152 vaccine, in individuals previously vaccinated with COVAXIN. Group 3: (BBV154 in COVISHIELD recipients) In this group, 250 participants will be recruited and administered with a booster dose of BBV154 vaccine, in individuals previously vaccinated with COVISHIELD. Group 4: (BBV152(COVAXIN) in COVISHIELD recipients) In this group, 125 participants will be recruited and administered with a booster dose of BBV152 (COVAXIN) vaccine, in individuals previously vaccinated with COVISHIELD. Group 5: (COVISHIELD in COVISHIELD recipients) In this group, 125 participants will be recruited and administered with a booster dose of Covishield vaccine, in individuals previously vaccinated with COVISHIELD.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 28, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 26, 2022
Actual (reported)May 3, 2022
Actual (reported)September 28, 2022
Actual (reported)September 29, 2022
Actual (reported)October 5, 2022
Actual (reported)Geometric mean titres 1
Serum neutralising antibody titer (NAb"s) by neutralizing antibody assays.
baseline
Geometric mean titres 2
Serum neutralising antibody titer (NAb"s) by neutralizing antibody assays.
Day 28+2
Geometric mean titres 3
Serum neutralising antibody titer (NAb"s) by neutralizing antibody assays.
Day 56 ± 7
Geometric mean titres 4
Day 28+2
Geometric mean titres 5
Day 56 ± 7
Cell mediated immune response
Day 28+2
Cell mediated immune response
Day 56 ± 7
Geometric mean titres
Day 28+2
250 participants will be recruited and administered with a booster dose of BBV154 vaccine in form of drops (0.5 mL) via intranasal route, in individuals previously vaccinated with COVAXIN.
125 participants will be recruited and administered with a booster dose of BBV152 vaccine, in individuals previously vaccinated with COVAXIN.
Administered BBV154 vaccine in form of drops (0.5 mL) via intranasal route
Administered BBV152 vaccine via intramuscular route
All India Institute of Medical Sciences
Patna, Bihar, 801507, India
ESIC Medical College and Hospital
Faridabad, Haryana, 121001, India
Vagus Super Specilaity Hospitals
Bangalore, Karnataka, 560003, India
Jeevan Rekha Hospital
Belagavi, Karnataka, 590002, India
Gillurkar Multispeciality Hopistal
Nagpur, Maharashtra, 440009, India
St. Theresa Hospital
Hyderabad, Telangana, 500018, India
Rana Hospital Pvt Ltd
Gorakhpur, Uttar Pradesh, 273001, India
Dr. Sanjay Rai, MBBS,MD
All India Institute of Medical Sciences
Dr Chandramani Singh, MBBS,MD
All India Institute of Medical Sciences
Dr Anil Kumar Pandey, MBBS,MD
ESIC Medical College and Hospital Faridabad
Dr Chandrashekhar S Gillurkar, MBBS,MD
Gillurkar Multispeciality Hopistal
875 participants (actual enrollment reported by the registry).
First Submitted
September 29, 2022
First Posted
October 5, 2022
Study Start
February 26, 2022
Actual (reported)ALACOVID Study for Vaccinated Subjects
Evaluation of Home Use COVID-19 Frequent Antigen Testing and Data Reporting
250 participants will be recruited and administered with a booster dose of BBV154 vaccine, in individuals previously vaccinated with COVISHIELD.
125 participants will be recruited and administered with a booster dose of BBV152 (COVAXIN) vaccine, in individuals previously vaccinated with COVISHIELD.
125 participants will be recruited and administered with a booster dose of Covishield vaccine, in individuals previously vaccinated with COVISHIELD.
Administered vaccine via intramuscular route
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Prakhar Hospital Pvt Ltd
Kanpur, Uttar Pradesh, 208002, India
AIIMS, New Delhi
New Delhi, 110029, India
Dr Amit Suresh Bhate, MBBS,MD
Jeevan Rekha Hospital
Dr Jitendra Singh Kushwaha, MBBS,MD
Prakhar Hospital Pvt Ltd
Dr Shivaraj K K, MBBS,MD
Vagus Super Specilaity Hospitals
Dr A Venkateshwar Rao, MBBS,MD
St. Theresa Hospital
Dr Ajeet Pratap Singh, MBBS,MD
Rana Hospital Pvt Ltd
Primary Completion
May 3, 2022
Actual (reported)Study Completion
September 28, 2022
Actual (reported)Last Updated
October 5, 2022
Record last verified: 2022-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: