Safety of the 15-valent pneumococcal conjugate vaccine: A phase I clinical trial
To evaluate the safety of the 15-valent pneumococcal conjugate vaccine (PCV15 (by LvZhu & Co. Ltd)) in healthy infants aged 2 months (minimum to 6 weeks) and 3 months old. This phase I clinical trial enrolled 80 subjects in Laishui County, Hebei Province, China. The total population was divided...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2022-11-01
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| Series: | Human Vaccines & Immunotherapeutics |
| Subjects: | |
| Online Access: | http://dx.doi.org/10.1080/21645515.2022.2116881 |
| _version_ | 1827806442272325632 |
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| author | Lu-Lu Pan Zhao Gao Wei-Wei Zhou Min-Jie Li Wen-Jian Fang Wen-Juan Ji Ying Zhao Lin Du Yu-Liang Zhao |
| author_facet | Lu-Lu Pan Zhao Gao Wei-Wei Zhou Min-Jie Li Wen-Jian Fang Wen-Juan Ji Ying Zhao Lin Du Yu-Liang Zhao |
| author_sort | Lu-Lu Pan |
| collection | DOAJ |
| description | To evaluate the safety of the 15-valent pneumococcal conjugate vaccine (PCV15 (by LvZhu & Co. Ltd)) in healthy infants aged 2 months (minimum to 6 weeks) and 3 months old. This phase I clinical trial enrolled 80 subjects in Laishui County, Hebei Province, China. The total population was divided into 4 age groups on average: 20 adults (≥18 years) and 20 children (1–5 years) all received one vaccine dose; 20 infants (3 months) received the vaccine according to a 3-dose schedule at 0, 1, and 2 months. Twenty infants (2 months, minimum of 6 weeks old) received the vaccine according to a 3-dose schedule of 0, 2, and 4 months. The adverse events (AEs) until 30 days after each dose and serious adverse events (SAEs) until 6 months after the whole dose were reported. The solicited and unsolicited AE frequencies and laboratory indices were similar among the treatment groups. No vaccine-related SAEs were reported. Most vaccine-related adverse events consisting of systemic and local reactions were fever and pain. One hypersensitivity manifested as systemic urticaria that occurred on the third day after the second dose in the 2-month group. The 15-valent pneumococcal conjugate vaccine was generally well tolerated in infants. |
| first_indexed | 2024-03-11T21:41:13Z |
| format | Article |
| id | doaj.art-ec0aa0e8d4f044098f941fd4d710c507 |
| institution | Directory Open Access Journal |
| issn | 2164-5515 2164-554X |
| language | English |
| last_indexed | 2024-03-11T21:41:13Z |
| publishDate | 2022-11-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj.art-ec0aa0e8d4f044098f941fd4d710c5072023-09-26T13:19:09ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2022-11-0118610.1080/21645515.2022.21168812116881Safety of the 15-valent pneumococcal conjugate vaccine: A phase I clinical trialLu-Lu Pan0Zhao Gao1Wei-Wei Zhou2Min-Jie Li3Wen-Jian Fang4Wen-Juan Ji5Ying Zhao6Lin Du7Yu-Liang Zhao8Hebei Province Centre for Disease Control and PreventionHebei Province Centre for Disease Control and PreventionLaishui County Center for Disease Control and PreventionHebei Province Centre for Disease Control and PreventionBeijing Zhifei Lvzhu Biopharmaceutical Co. LtdLaishui County Center for Disease Control and PreventionBeijing Zhifei Lvzhu Biopharmaceutical Co. LtdBeijing Zhifei Lvzhu Biopharmaceutical Co. LtdHebei Province Centre for Disease Control and PreventionTo evaluate the safety of the 15-valent pneumococcal conjugate vaccine (PCV15 (by LvZhu & Co. Ltd)) in healthy infants aged 2 months (minimum to 6 weeks) and 3 months old. This phase I clinical trial enrolled 80 subjects in Laishui County, Hebei Province, China. The total population was divided into 4 age groups on average: 20 adults (≥18 years) and 20 children (1–5 years) all received one vaccine dose; 20 infants (3 months) received the vaccine according to a 3-dose schedule at 0, 1, and 2 months. Twenty infants (2 months, minimum of 6 weeks old) received the vaccine according to a 3-dose schedule of 0, 2, and 4 months. The adverse events (AEs) until 30 days after each dose and serious adverse events (SAEs) until 6 months after the whole dose were reported. The solicited and unsolicited AE frequencies and laboratory indices were similar among the treatment groups. No vaccine-related SAEs were reported. Most vaccine-related adverse events consisting of systemic and local reactions were fever and pain. One hypersensitivity manifested as systemic urticaria that occurred on the third day after the second dose in the 2-month group. The 15-valent pneumococcal conjugate vaccine was generally well tolerated in infants.http://dx.doi.org/10.1080/21645515.2022.2116881pneumococcal15-valent conjugate vaccinesafetyphase i clinical trial |
| spellingShingle | Lu-Lu Pan Zhao Gao Wei-Wei Zhou Min-Jie Li Wen-Jian Fang Wen-Juan Ji Ying Zhao Lin Du Yu-Liang Zhao Safety of the 15-valent pneumococcal conjugate vaccine: A phase I clinical trial Human Vaccines & Immunotherapeutics pneumococcal 15-valent conjugate vaccine safety phase i clinical trial |
| title | Safety of the 15-valent pneumococcal conjugate vaccine: A phase I clinical trial |
| title_full | Safety of the 15-valent pneumococcal conjugate vaccine: A phase I clinical trial |
| title_fullStr | Safety of the 15-valent pneumococcal conjugate vaccine: A phase I clinical trial |
| title_full_unstemmed | Safety of the 15-valent pneumococcal conjugate vaccine: A phase I clinical trial |
| title_short | Safety of the 15-valent pneumococcal conjugate vaccine: A phase I clinical trial |
| title_sort | safety of the 15 valent pneumococcal conjugate vaccine a phase i clinical trial |
| topic | pneumococcal 15-valent conjugate vaccine safety phase i clinical trial |
| url | http://dx.doi.org/10.1080/21645515.2022.2116881 |
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