A multi-centre, post-marketing surveillance study of Vi polysaccharide–tetanus toxoid conjugate vaccine (Typbar TCV®) in India
A typhoid Vi capsular-polysaccharide tetanus toxoid conjugate vaccine (Typbar-TCV®) was recommended by the World Health Organization for use in children >6 months of age. The present post-marketing surveillance study was intended to assess the clinical safety of approximately 11 million doses of...
| Main Authors: | , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Taylor & Francis Group
2022-01-01
|
| Series: | Human Vaccines & Immunotherapeutics |
| Subjects: | |
| Online Access: | http://dx.doi.org/10.1080/21645515.2021.1947761 |
| _version_ | 1797673264424681472 |
|---|---|
| author | Raghu Reddy Bhargav Reddy Vamshi Sarangi Siddharth Reddy Raches Ella Krishna Mohan Vadrevu |
| author_facet | Raghu Reddy Bhargav Reddy Vamshi Sarangi Siddharth Reddy Raches Ella Krishna Mohan Vadrevu |
| author_sort | Raghu Reddy |
| collection | DOAJ |
| description | A typhoid Vi capsular-polysaccharide tetanus toxoid conjugate vaccine (Typbar-TCV®) was recommended by the World Health Organization for use in children >6 months of age. The present post-marketing surveillance study was intended to assess the clinical safety of approximately 11 million doses of TCV sold till 2019 in a diverse age range Indian population. Both active and passive post-marketing surveillance studies were conducted at multiple centers. Active surveillance was performed in two periods, Period-I: February to October 2016, Period-II: April 2017 to October 2018. In Period-II, the Brighton Collaboration Criteria adverse event case definitions were used. Passive surveillance was performed from February 2016 to December 2019 through voluntary reporting by pediatricians across India. During the active surveillance, 1147 adverse events were reported among 4,991 (23.0%) subjects in Period-I, and 596 adverse events among 3898 (21.3%) subjects in Period-II. The most frequent adverse events were fever (9.2% and 12.02%in Periods I and II, respectively), pain at the injection site (8.3% and 7.33%), and swelling (4.0% and 1.93%). No serious adverse events (SAEs) were reported during either Period. Passive surveillance revealed 235 adverse events, including 25 SAEs requiring hospitalization, of which two were due to typhoid fever. All the events mentioned above occurred within one week of vaccination, and all the subjects have recovered from AEs with medications. All reported adverse events resolved with no clinical sequelae. Observations in this study are consistent with the pre-licensure studies with no additional safety signals detected, confirming that Typbar-TCV® is safe. Abbreviations: AE: Adverse event; LMIC: low- and middle-income countries; PMS: Post-marketing surveillance; SAE: Serious adverse event; TCV: Vi-polysaccharide tetanus –toxoid conjugate vaccine (Typbar-TCV®) |
| first_indexed | 2024-03-11T21:43:00Z |
| format | Article |
| id | doaj.art-b96f57f97c4d40f8b80ad0d32a0e4ad6 |
| institution | Directory Open Access Journal |
| issn | 2164-5515 2164-554X |
| language | English |
| last_indexed | 2024-03-11T21:43:00Z |
| publishDate | 2022-01-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj.art-b96f57f97c4d40f8b80ad0d32a0e4ad62023-09-26T12:47:03ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2022-01-0118110.1080/21645515.2021.19477611947761A multi-centre, post-marketing surveillance study of Vi polysaccharide–tetanus toxoid conjugate vaccine (Typbar TCV®) in IndiaRaghu Reddy0Bhargav Reddy1Vamshi Sarangi2Siddharth Reddy3Raches Ella4Krishna Mohan Vadrevu5Bharat Biotech International LtdBharat Biotech International LtdBharat Biotech International LtdBharat Biotech International LtdBharat Biotech International LtdBharat Biotech International LtdA typhoid Vi capsular-polysaccharide tetanus toxoid conjugate vaccine (Typbar-TCV®) was recommended by the World Health Organization for use in children >6 months of age. The present post-marketing surveillance study was intended to assess the clinical safety of approximately 11 million doses of TCV sold till 2019 in a diverse age range Indian population. Both active and passive post-marketing surveillance studies were conducted at multiple centers. Active surveillance was performed in two periods, Period-I: February to October 2016, Period-II: April 2017 to October 2018. In Period-II, the Brighton Collaboration Criteria adverse event case definitions were used. Passive surveillance was performed from February 2016 to December 2019 through voluntary reporting by pediatricians across India. During the active surveillance, 1147 adverse events were reported among 4,991 (23.0%) subjects in Period-I, and 596 adverse events among 3898 (21.3%) subjects in Period-II. The most frequent adverse events were fever (9.2% and 12.02%in Periods I and II, respectively), pain at the injection site (8.3% and 7.33%), and swelling (4.0% and 1.93%). No serious adverse events (SAEs) were reported during either Period. Passive surveillance revealed 235 adverse events, including 25 SAEs requiring hospitalization, of which two were due to typhoid fever. All the events mentioned above occurred within one week of vaccination, and all the subjects have recovered from AEs with medications. All reported adverse events resolved with no clinical sequelae. Observations in this study are consistent with the pre-licensure studies with no additional safety signals detected, confirming that Typbar-TCV® is safe. Abbreviations: AE: Adverse event; LMIC: low- and middle-income countries; PMS: Post-marketing surveillance; SAE: Serious adverse event; TCV: Vi-polysaccharide tetanus –toxoid conjugate vaccine (Typbar-TCV®)http://dx.doi.org/10.1080/21645515.2021.1947761typhoid feverconjugate vaccinesafetypost-marketing surveillanceadverse events |
| spellingShingle | Raghu Reddy Bhargav Reddy Vamshi Sarangi Siddharth Reddy Raches Ella Krishna Mohan Vadrevu A multi-centre, post-marketing surveillance study of Vi polysaccharide–tetanus toxoid conjugate vaccine (Typbar TCV®) in India Human Vaccines & Immunotherapeutics typhoid fever conjugate vaccine safety post-marketing surveillance adverse events |
| title | A multi-centre, post-marketing surveillance study of Vi polysaccharide–tetanus toxoid conjugate vaccine (Typbar TCV®) in India |
| title_full | A multi-centre, post-marketing surveillance study of Vi polysaccharide–tetanus toxoid conjugate vaccine (Typbar TCV®) in India |
| title_fullStr | A multi-centre, post-marketing surveillance study of Vi polysaccharide–tetanus toxoid conjugate vaccine (Typbar TCV®) in India |
| title_full_unstemmed | A multi-centre, post-marketing surveillance study of Vi polysaccharide–tetanus toxoid conjugate vaccine (Typbar TCV®) in India |
| title_short | A multi-centre, post-marketing surveillance study of Vi polysaccharide–tetanus toxoid conjugate vaccine (Typbar TCV®) in India |
| title_sort | multi centre post marketing surveillance study of vi polysaccharide tetanus toxoid conjugate vaccine typbar tcv r in india |
| topic | typhoid fever conjugate vaccine safety post-marketing surveillance adverse events |
| url | http://dx.doi.org/10.1080/21645515.2021.1947761 |
| work_keys_str_mv | AT raghureddy amulticentrepostmarketingsurveillancestudyofvipolysaccharidetetanustoxoidconjugatevaccinetypbartcvinindia AT bhargavreddy amulticentrepostmarketingsurveillancestudyofvipolysaccharidetetanustoxoidconjugatevaccinetypbartcvinindia AT vamshisarangi amulticentrepostmarketingsurveillancestudyofvipolysaccharidetetanustoxoidconjugatevaccinetypbartcvinindia AT siddharthreddy amulticentrepostmarketingsurveillancestudyofvipolysaccharidetetanustoxoidconjugatevaccinetypbartcvinindia AT rachesella amulticentrepostmarketingsurveillancestudyofvipolysaccharidetetanustoxoidconjugatevaccinetypbartcvinindia AT krishnamohanvadrevu amulticentrepostmarketingsurveillancestudyofvipolysaccharidetetanustoxoidconjugatevaccinetypbartcvinindia AT raghureddy multicentrepostmarketingsurveillancestudyofvipolysaccharidetetanustoxoidconjugatevaccinetypbartcvinindia AT bhargavreddy multicentrepostmarketingsurveillancestudyofvipolysaccharidetetanustoxoidconjugatevaccinetypbartcvinindia AT vamshisarangi multicentrepostmarketingsurveillancestudyofvipolysaccharidetetanustoxoidconjugatevaccinetypbartcvinindia AT siddharthreddy multicentrepostmarketingsurveillancestudyofvipolysaccharidetetanustoxoidconjugatevaccinetypbartcvinindia AT rachesella multicentrepostmarketingsurveillancestudyofvipolysaccharidetetanustoxoidconjugatevaccinetypbartcvinindia AT krishnamohanvadrevu multicentrepostmarketingsurveillancestudyofvipolysaccharidetetanustoxoidconjugatevaccinetypbartcvinindia |