Safety and Immunogenicity of Fully Liquid Hexavalent DTaP-IPV-HepB-Hib Vaccine in Healthy Infants in Russian Federation
Relevance/aims: Multivalent vaccines are crucial in the control of diseases including diphtheria (D), tetanus (T), pertussis (P), polio, hepatitis B (HB), and Haemophilus influenzae type b (Hib [PRP~T]). To evaluate the safety and immunogenicity of a fully liquid, hexavalent DTaP-IPV-HB-PRP~Tvaccine...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | Russian |
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Numikom LLC
2019-06-01
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| Series: | Эпидемиология и вакцинопрофилактика |
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| Online Access: | https://www.epidemvac.ru/jour/article/view/739 |
| _version_ | 1826567460944347136 |
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| author | L. S. Namazova-Baranova S. M. Kharit O. A. Perminova V. V. Romanenko I. V. Osipova А. G. Asatryan A. V. Goldstein S. B'Chir O. I. Lyabis |
| author_facet | L. S. Namazova-Baranova S. M. Kharit O. A. Perminova V. V. Romanenko I. V. Osipova А. G. Asatryan A. V. Goldstein S. B'Chir O. I. Lyabis |
| author_sort | L. S. Namazova-Baranova |
| collection | DOAJ |
| description | Relevance/aims: Multivalent vaccines are crucial in the control of diseases including diphtheria (D), tetanus (T), pertussis (P), polio, hepatitis B (HB), and Haemophilus influenzae type b (Hib [PRP~T]). To evaluate the safety and immunogenicity of a fully liquid, hexavalent DTaP-IPV-HB-PRP~Tvaccine in infants in the Russian Federation.Materials & methods. Infants (N=100) who had received a standalone HB vaccine within 24 hours after birth and at 1 month of age and a pentavalent (DTaP-IPV/PRP~T) vaccine at 3 and 4.5 months of age were enrolled and received the hexavalent DTaP-IPV-HB-PRP~T vaccine at 6 months of age. Safety was assessed from parental reports and immunogenicity using validated assays.Results. There were no safety concerns, with 38.0% and 49.0% of participants experiencing ≥ 1 solicited injection site and ≥ 1 solicited systemic reaction within 7 days after vaccination, respectively, and 16.0% reporting an unsolicited adverse event (AE) within 30 days after vaccination. The incidence of each solicited reaction with severity Grade 3 was ≤6.0% and all unsolicited AEs were Grade 1 or 2. Most AEs started ≤ 3 days post-vaccination, were short-lived, and resolved spontaneously. There were no serious AEs. On month post-vaccination 100.0% of participants had antibodies ≥ 10 mIU/ mL for anti-HBs, ≥ 0.01 IU/mL for anti-D and anti-T, ≥8 (1/dil) for anti-polio-1,2, 3, and 97.9% of participants had anti-PRP antibodies ≥ 0.15 gg/ml. For anti-PT and anti-FHA, GMCs were in the expected range.Conclusion. These results support vaccination with the DTaP-IPV-HB-PRP~T vaccine in the Russian Federation following the recommended national immunization schedule. |
| first_indexed | 2024-04-10T02:49:46Z |
| format | Article |
| id | doaj.art-3d8cac9bad5944f0991cb0b9a05e1544 |
| institution | Directory Open Access Journal |
| issn | 2073-3046 2619-0494 |
| language | Russian |
| last_indexed | 2025-03-14T11:07:54Z |
| publishDate | 2019-06-01 |
| publisher | Numikom LLC |
| record_format | Article |
| series | Эпидемиология и вакцинопрофилактика |
| spelling | doaj.art-3d8cac9bad5944f0991cb0b9a05e15442025-03-02T10:40:31ZrusNumikom LLCЭпидемиология и вакцинопрофилактика2073-30462619-04942019-06-01183283910.31631/2073-3046-2019-18-3-28-39537Safety and Immunogenicity of Fully Liquid Hexavalent DTaP-IPV-HepB-Hib Vaccine in Healthy Infants in Russian FederationL. S. Namazova-Baranova0S. M. Kharit1O. A. Perminova2V. V. Romanenko3I. V. Osipova4А. G. Asatryan5A. V. Goldstein6S. B'Chir7O. I. Lyabis8Pirogov Russian National Research Medical UniversityChildren’s Scientific and Clinical Center for Infectious DiseasesChildren’s Outpatient Clinic No. 5Ural State Medical UniversityAltay State Medical UniversityPasteur Institute of Epidemiology and MicrobiologySanofi PasteurSanofi PasteurSanofi PasteurRelevance/aims: Multivalent vaccines are crucial in the control of diseases including diphtheria (D), tetanus (T), pertussis (P), polio, hepatitis B (HB), and Haemophilus influenzae type b (Hib [PRP~T]). To evaluate the safety and immunogenicity of a fully liquid, hexavalent DTaP-IPV-HB-PRP~Tvaccine in infants in the Russian Federation.Materials & methods. Infants (N=100) who had received a standalone HB vaccine within 24 hours after birth and at 1 month of age and a pentavalent (DTaP-IPV/PRP~T) vaccine at 3 and 4.5 months of age were enrolled and received the hexavalent DTaP-IPV-HB-PRP~T vaccine at 6 months of age. Safety was assessed from parental reports and immunogenicity using validated assays.Results. There were no safety concerns, with 38.0% and 49.0% of participants experiencing ≥ 1 solicited injection site and ≥ 1 solicited systemic reaction within 7 days after vaccination, respectively, and 16.0% reporting an unsolicited adverse event (AE) within 30 days after vaccination. The incidence of each solicited reaction with severity Grade 3 was ≤6.0% and all unsolicited AEs were Grade 1 or 2. Most AEs started ≤ 3 days post-vaccination, were short-lived, and resolved spontaneously. There were no serious AEs. On month post-vaccination 100.0% of participants had antibodies ≥ 10 mIU/ mL for anti-HBs, ≥ 0.01 IU/mL for anti-D and anti-T, ≥8 (1/dil) for anti-polio-1,2, 3, and 97.9% of participants had anti-PRP antibodies ≥ 0.15 gg/ml. For anti-PT and anti-FHA, GMCs were in the expected range.Conclusion. These results support vaccination with the DTaP-IPV-HB-PRP~T vaccine in the Russian Federation following the recommended national immunization schedule.https://www.epidemvac.ru/jour/article/view/739childrencombination vaccinehexavalentvaccinefully liquidprimary immunizationsafetyreactogenicityimmunogenicity |
| spellingShingle | L. S. Namazova-Baranova S. M. Kharit O. A. Perminova V. V. Romanenko I. V. Osipova А. G. Asatryan A. V. Goldstein S. B'Chir O. I. Lyabis Safety and Immunogenicity of Fully Liquid Hexavalent DTaP-IPV-HepB-Hib Vaccine in Healthy Infants in Russian Federation Эпидемиология и вакцинопрофилактика children combination vaccine hexavalent vaccine fully liquid primary immunization safety reactogenicity immunogenicity |
| title | Safety and Immunogenicity of Fully Liquid Hexavalent DTaP-IPV-HepB-Hib Vaccine in Healthy Infants in Russian Federation |
| title_full | Safety and Immunogenicity of Fully Liquid Hexavalent DTaP-IPV-HepB-Hib Vaccine in Healthy Infants in Russian Federation |
| title_fullStr | Safety and Immunogenicity of Fully Liquid Hexavalent DTaP-IPV-HepB-Hib Vaccine in Healthy Infants in Russian Federation |
| title_full_unstemmed | Safety and Immunogenicity of Fully Liquid Hexavalent DTaP-IPV-HepB-Hib Vaccine in Healthy Infants in Russian Federation |
| title_short | Safety and Immunogenicity of Fully Liquid Hexavalent DTaP-IPV-HepB-Hib Vaccine in Healthy Infants in Russian Federation |
| title_sort | safety and immunogenicity of fully liquid hexavalent dtap ipv hepb hib vaccine in healthy infants in russian federation |
| topic | children combination vaccine hexavalent vaccine fully liquid primary immunization safety reactogenicity immunogenicity |
| url | https://www.epidemvac.ru/jour/article/view/739 |
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