Immunogenicity, reactogenicity and safety of human rotavirus vaccine (RIX4414) in Indian infants
| Autor: | Htay Htay Han, Sanjoy K Datta, Hans L. Bock, Andrée Delem, Sujit K. Bhattacharya, Dutta P, Gagandeep Kang, Anand Pandit, P.V. Suryakiran, Anil Narang, Anuradha Bose |
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| Rok vydání: | 2009 |
| Předmět: |
Male
Pediatrics medicine.medical_specialty Drug-Related Side Effects and Adverse Reactions Immunology Immunization Secondary Administration Oral India Antibodies Viral Vaccines Attenuated Placebo Rotavirus Infections law.invention Placebos Randomized controlled trial law medicine Humans General Pharmacology Toxicology and Pharmaceutics Seroconversion Reactogenicity biology business.industry Immunogenicity Rotavirus Vaccines Infant Vaccination Immunization biology.protein Female Antibody business |
| Zdroj: | Human Vaccines. 5:414-419 |
| ISSN: | 1554-8619 1554-8600 |
| DOI: | 10.4161/hv.5.6.8176 |
| Popis: | This study was undertaken to assess the immunogenicity, reactogenicity and safety of two doses of an oral live-attenuated human rotavirus vaccine, strain RIX4414 (Rotarix()) in an Indian setting.The seroconversion rate observed one month post-dose 2 in the RIX4414 group 58.3% [95% CI: 48.7; 67.4] was significantly higher when compared to the placebo group 6.3%; [95% CI: 2.5; 12.5]. The reactogenicity and safety profile was similar for both groups.Healthy infants (N = 363), approximately eight weeks of age were enrolled to receive two doses of RIX4414 vaccine (n = 182) or placebo (n = 181) separated by one month. To assess the immune response, blood samples were taken before vaccination and one month post-dose 2 of RIX4414/placebo. Solicited symptoms were collected for eight-days post each dose and safety data was collected throughout the study.Two doses of RIX4414 (Rotarix()) were immunogenic, had a good safety profile and were well-tolerated when administered to healthy Indian infants.ClinicalTrials.gov; NCT00289172; eTrack 103792. |
| Databáze: | OpenAIRE |
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