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0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z"></path></svg></button></li></ul></li></ul></div> <script src="//a.academia-assets.com/assets/webpack_bundles/fast_loswp-bundle-5a6217ebba1e3e193cb1032ca4e3bea5eb426dd3928dd536d7bf14b642b1cd3a.js" defer="defer"></script><script>window.loswp = {}; window.loswp.author = 154784666; window.loswp.bulkDownloadFilterCounts = {}; window.loswp.hasDownloadableAttachment = true; window.loswp.hasViewableAttachments = true; // TODO: just use routes for this window.loswp.loginUrl = "https://www.academia.edu/login?post_login_redirect_url=https%3A%2F%2Fwww.academia.edu%2F49725247%2FA_phase_III_randomized_controlled_study_to_assess_the_immunogenicity_and_tolerability_of_DTPw_HBV_Hib_a_liquid_pentavalent_vaccine_in_Indian_infants%3Fauto%3Ddownload"; window.loswp.translateUrl = 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To avoid such reactions which occur from foreign compounds, WHO suggested manufacture of DTwP vaccine using semi-synthetic medium. The phase III trial reported here was conducted to assess the immunogenicity, tolerability and safety of a new DTwP vaccine manufactured using semi-synthetic medium for both tetanus and diphtheria toxoids in comparison with the routinely manufactured DTwP vaccine. Methods: In all, 331 infants aged 6-8 weeks were enrolled, out of which 308 completed the study. The vaccination was done at 6-10-14 weeks following EPI/WHO recommended immunization schedule. Blood samples were collected prior to the administration of first dose and one month after the third dose. Results: Postvaccination, geometric mean titres for each component did not differ significantly amongst the two study groups. Though, the immunogenicity results were comparable between the two vaccines, the incidence of adverse events was comparatively low in semi-synthetic vaccine as against the routine vaccine group for all the three doses. Conclusions: The semi-synthetic DTwP vaccine was immunogenic and showed a significant lower incidence of local adverse events in comparison to the routine vaccine. This vaccine is now being used in the routine vaccination programme both as a triple antigen (DTwP alone) as well as a combination with Hepatitis B and/or Haemophilus influenzae type b vaccine.","publication_date":"2011,,","publication_name":"Vaccine","grobid_abstract_attachment_id":"67987438"},"document_type":"paper","pre_hit_view_count_baseline":null,"quality":"high","language":"en","title":"A phase III randomized, controlled study to assess the immunogenicity and tolerability of DTPw-HBV-Hib, a liquid pentavalent vaccine in Indian infants","broadcastable":true,"draft":null,"has_indexable_attachment":true,"indexable":true}}["work"]; window.loswp.workCoauthors = [154784666]; window.loswp.locale = "en"; window.loswp.countryCode = "SG"; window.loswp.cwvAbTestBucket = ""; window.loswp.designVariant = "ds_vanilla"; window.loswp.fullPageMobileSutdModalVariant = "full_page_mobile_sutd_modal"; window.loswp.useOptimizedScribd4genScript = false; window.loswp.appleClientId = 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data-collection-position="1" data-entity-id="5981921" data-sort-order="default"><a class="ds-related-work--title js-wsj-grid-card-title ds2-5-body-md ds2-5-body-link" href="https://www.academia.edu/5981921/A_phase_III_randomized_controlled_study_to_assess_and_compare_the_immunogenicity_and_tolerability_of_single_and_multi_dose_vials_of_DTwP_Hib_a_fully_liquid_quadravalent_vaccine_and_their_comparison_with_TETRAct_Hib_vaccine_in_Indian_infants_aged_6_14_weeks">A phase III randomized, controlled study to assess and compare the immunogenicity and tolerability of single and multi-dose vials of DTwP-Hib, a fully liquid quadravalent vaccine and their comparison with TETRAct-Hib vaccine in Indian infants aged 6–14 weeks</a><div class="ds-related-work--metadata"><a class="js-wsj-grid-card-author ds2-5-body-sm ds2-5-body-link" data-author-id="8928516" href="https://independent.academia.edu/arunprasath10">arun prasath</a></div><p class="ds-related-work--metadata ds2-5-body-xs">Vaccine, 2011</p><div class="ds-related-work--ctas"><button class="ds2-5-text-link ds2-5-text-link--inline js-swp-download-button" data-signup-modal="{"location":"wsj-grid-card-download-pdf-modal","work_title":"A phase III randomized, controlled study to assess and compare the immunogenicity and tolerability of single and multi-dose vials of DTwP-Hib, a fully liquid quadravalent vaccine and their comparison with TETRAct-Hib vaccine in Indian infants aged 6–14 weeks","attachmentId":49068386,"attachmentType":"pdf","work_url":"https://www.academia.edu/5981921/A_phase_III_randomized_controlled_study_to_assess_and_compare_the_immunogenicity_and_tolerability_of_single_and_multi_dose_vials_of_DTwP_Hib_a_fully_liquid_quadravalent_vaccine_and_their_comparison_with_TETRAct_Hib_vaccine_in_Indian_infants_aged_6_14_weeks","alternativeTracking":true}"><span class="material-symbols-outlined" style="font-size: 18px" translate="no">download</span><span class="ds2-5-text-link__content">Download free 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href="https://www.academia.edu/97724322/Immunogenicity_and_safety_of_an_indigenously_manufactured_reconstituted_pentavalent_DTwP_HBV_Hib_vaccine_in_comparison_with_a_foreign_competitor_following_primary_and_booster_immunization_in_Indian_children">Immunogenicity and safety of an indigenously manufactured reconstituted pentavalent (DTwP-HBV+Hib) vaccine in comparison with a foreign competitor following primary and booster immunization in Indian children</a><div class="ds-related-work--metadata"><a class="js-wsj-grid-card-author ds2-5-body-sm ds2-5-body-link" data-author-id="259596214" href="https://independent.academia.edu/vikasverma408">vikas verma</a></div><p class="ds-related-work--metadata ds2-5-body-xs">Human Vaccines, 2011</p><div class="ds-related-work--ctas"><button class="ds2-5-text-link ds2-5-text-link--inline js-swp-download-button" data-signup-modal="{"location":"wsj-grid-card-download-pdf-modal","work_title":"Immunogenicity and safety of an indigenously manufactured 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class="ds2-5-text-link__content">View PDF</span><span class="material-symbols-outlined" style="font-size: 18px" translate="no">chevron_right</span></a></div></div><div class="ds-related-work--container js-wsj-grid-card" data-collection-position="3" data-entity-id="125179240" data-sort-order="default"><a class="ds-related-work--title js-wsj-grid-card-title ds2-5-body-md ds2-5-body-link" href="https://www.academia.edu/125179240/Immunogenicity_and_safety_of_DTPW_HEPB_HIB_PRP_T_vaccine_Pentavac_in_infants_aged_2_7_months_a_post_marketing_phase_4_clinical_trial_study">Immunogenicity and safety of DTPW-HEPB-HIB (PRP-T) vaccine (Pentavac) in infants aged 2–7 months: a post marketing phase 4 clinical trial study</a><div class="ds-related-work--metadata"><a class="js-wsj-grid-card-author ds2-5-body-sm ds2-5-body-link" data-author-id="304551463" href="https://tums.academia.edu/ErfanehJafari">Erfaneh Jafari</a><span>, </span><a class="js-wsj-grid-card-author ds2-5-body-sm ds2-5-body-link" data-author-id="11135871" href="https://tums.academia.edu/RezaAzizian">Reza Azizian, PhD</a></div><p class="ds-related-work--metadata ds2-5-body-xs">Russian Journal of Infection and Immunity, 2024</p><p class="ds-related-work--abstract ds2-5-body-sm">Background. Vaccines play a critical role in safeguarding public health, particularly for children. It is imperative to proactively address safety concerns to uphold trust in their effectiveness and safety. Skepticism surrounding vaccines can have significant adverse effects on the overall well-being of the entire population, potentially leading to individuals opting out of vital vaccinations, thereby posing risks to public health. Thus, ensuring confidence in vaccine safety remains paramount. Materials and methods. This phase four clinical trial was conducted as a post-marketing study (PMS) on 2 to 7 month old healthy infants (N = 539) to evaluate immunity and safety of Indian pentavalent vaccine containing Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus influenza type b [DTPW-HEP B-HIB (PRP-T)/PENTAVAC] in four different centers at Tehran province. Blood samples were collected from eligible infants before receiving the vaccine (2 months of age) and 1 month after the third dose (7 months of age) to determine antibodies against all antigens in the pentavalent vaccine using ELISA. Results. The results indicated that the immune responses demonstrated seroprotection and protective antibody levels after three doses of the vaccine for Haemophilus influenza b, diphtheria, tetanus, hepatitis B virus and Bordetella pertussis were 99.1%, 98.7%, 99.8%, 99.4% and 69.6%, respectively. Statistical analysis showed that the P-value for all vaccine components was similar (P < 0.001). The five most common side effects reported were mild fever (10%), erythema at the vaccination site (9.1%), inflammation (4.3%), pain at the vaccination site (3.3%), and restlessness (2.6%). Conclusion. This study's findings demonstrated a significant increase in antibody levels against all five vaccine components. In light of these results, it can be concluded that the Pentavalent vaccine is not only effective in enhancing immunity against multiple diseases but also presents minimal risk of side effects in the study population. These findings contribute to the body of evidence supporting the safety and efficacy of vaccines, underscoring their crucial role in protecting public health.</p><div class="ds-related-work--ctas"><button class="ds2-5-text-link ds2-5-text-link--inline js-swp-download-button" data-signup-modal="{"location":"wsj-grid-card-download-pdf-modal","work_title":"Immunogenicity and safety of DTPW-HEPB-HIB (PRP-T) vaccine (Pentavac) in infants aged 2–7 months: a post marketing phase 4 clinical trial study","attachmentId":119268245,"attachmentType":"pdf","work_url":"https://www.academia.edu/125179240/Immunogenicity_and_safety_of_DTPW_HEPB_HIB_PRP_T_vaccine_Pentavac_in_infants_aged_2_7_months_a_post_marketing_phase_4_clinical_trial_study","alternativeTracking":true}"><span class="material-symbols-outlined" style="font-size: 18px" translate="no">download</span><span class="ds2-5-text-link__content">Download free PDF</span></button><a class="ds2-5-text-link ds2-5-text-link--inline js-wsj-grid-card-view-pdf" href="https://www.academia.edu/125179240/Immunogenicity_and_safety_of_DTPW_HEPB_HIB_PRP_T_vaccine_Pentavac_in_infants_aged_2_7_months_a_post_marketing_phase_4_clinical_trial_study"><span class="ds2-5-text-link__content">View PDF</span><span class="material-symbols-outlined" style="font-size: 18px" translate="no">chevron_right</span></a></div></div><div class="ds-related-work--container js-wsj-grid-card" data-collection-position="4" data-entity-id="78382381" data-sort-order="default"><a class="ds-related-work--title js-wsj-grid-card-title ds2-5-body-md ds2-5-body-link" href="https://www.academia.edu/78382381/Safety_immune_lot_to_lot_consistency_and_non_inferiority_of_a_fully_liquid_pentavalent_DTwP_HepB_Hib_vaccine_in_Healthy_Indian_Toddlers_and_Infants">Safety, immune lot-to-lot consistency and non-inferiority of a fully liquid pentavalent DTwP-HepB-Hib vaccine in Healthy Indian Toddlers and Infants</a><div class="ds-related-work--metadata"><a class="js-wsj-grid-card-author ds2-5-body-sm ds2-5-body-link" data-author-id="42264162" href="https://independent.academia.edu/jugeshchhatwal">jugesh chhatwal</a></div><p class="ds-related-work--metadata ds2-5-body-xs">Human vaccines & immunotherapeutics, 2015</p><p class="ds-related-work--abstract ds2-5-body-sm">Pentavalent combination vaccines are important tools to strengthen the immunization programs in numerous countries throughout the world. A large number of countries have recognized the value of combination vaccines and have introduced whole cell pentavalent vaccines into their immunization programs. A phase III, multi-center, randomized, single blinded study of a fully liquid pentavalent DTwP-HepB-Hib investigational vaccine (Shan5™) was conducted across India in two cohorts: 15 toddlers were evaluated for safety and immunogenicity following a single booster dose (Cohort 1) followed by 1085 infants (Cohort 2) evaluated for immunogenicity and safety following three-dose primary immunization of the investigational vaccine or a locally licensed comparator vaccine (Pentavac SD). 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