A phase III randomized, controlled study to assess the immunogenicity and tolerability of DTPw–HBV–Hib, a liquid pentavalent vaccine in Indian infants

Sharma, Hitt; Yadav, Sangita; Lalwani, Sanjay; Gupta, Vijay; Kapre, Subhash V.; Jadhav, Suresh; Chakravarty, Anita; Parekh, Sameer; Palkar, Sonali

doi:10.1016/j.vaccine.2011.01.054

Cited by 21 publications

(23 citation statements)

References 15 publications

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“…Safety data from these studies showed pain, swelling and erythema as the most commonly reported solicited local reactions, and most frequently reported solicited systemic reactions were fever and irritability comparable with our observations. [12][13][14][15][16][17] For several decades, inactivated whole-cell pertussis vaccines (wP) have been part of national childhood vaccination programs, dramatically reducing the considerable public health impact of pertussis. 18 In most emerging and developing countries, DTP vaccination in infants.…”

Section: Discussionmentioning

confidence: 99%

“…Although direct comparisons are not possible due to differences in data collection and analysis methods, seroprotection/seroconversion rates and reactogenicity profile were found to be similar to other pentavalent vaccines studied in Indian infants. [12][13][14][15][16][17] This study was designed to assess immunogenicity in terms of accepted seroprotection or seroconversion criteria against all five vaccine antigens one month after the third vaccination, and safety and tolerability after each vaccine dose. The study was conducted according to Good Clinical Practice and in accordance with the Ethical Guidelines for Biomedical Research on Human Subjects and Declaration of Helsinki.…”

Section: Discussionmentioning

confidence: 99%

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A phase III single arm, multicenter, open-label study to assess the immunogenicity and tolerability of a pentavalent DTwP–HepB–Hib vaccine in indian infants

Eregowda

Lalwani

Chatterjee

et al. 2013

Human Vaccines & Immunotherapeutics

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

A phase III single arm, multicenter, open-label study to assess the immunogenicity and tolerability of a pentavalent DTwP–HepB–Hib vaccine in indian infants

Eregowda

Lalwani

Chatterjee

et al. 2013

Human Vaccines & Immunotherapeutics

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“…In addition, the results of different studies show that pentavalent vaccine was safe and tolerable and possessed a high level of immunizing for all molecular antigens and some biological reactions (21)(22)(23)(24).…”

Section: 2%) But a Closer Look At The Results Revealed That Most Omentioning

confidence: 99%

The Comparison of the adverse events of Pentavalent and DPT vaccines in 2-6 months infants in Iran: A national study

Moradi

Khazaei

Zahraei

et al. 2019

Preprint

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Background Vaccination is the most remarkable intervention in public health and is an effective strategy in order to control infectious diseases among infants. This study attempted to compare the adverse events of Pentavalent and DPT vaccines together. Methods This is a cross sectional (analytical-descriptive) study in which the 2-6 months healthy infants, having received DPT in 2013 and Pentavalent in 2015, were studied for their experienced adverse events related to these vaccines. Percentage, mean, standard deviation and chi-square tests were used to describe and analyze the data. Results The results showed that 10464 and 17561 adverse events, which are associated with DPT and Pentavalent respectively, were recorded in the infants who received these vaccines throughout Iran. Mazandaran, Qazvin and Golestan provinces reported the highest number of adverse events, respectively (15.74%, 11.25%, and 9.12%). Moreover, Pentavalent seemed to have more recorded adverse events compared to DPT, high fever had the highest record rate for DPT (47.4%) and mild localized complications was the highest for Pentavalent (31.68%). There was a significant relationship between the kind of vaccine and the type of reaction, adverse event categorization, the country produced the vaccine and the infants' place of residence (p<0.05). Conclusion Severe localized adverse events including high fever, vomiting, diarrhea and restlessness seemed to be less in Pentavalent compared to DPT vaccine. Therefore, substituting Pentavalent for DPT in infants seems to reduce the adverse events among them.

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“…DTwP-HB-Hib vaccine is a suitable for immunization program in developing countries. [ 9 , 11 , 19 , 25 , 26 ].…”

Section: Discussionmentioning

confidence: 99%

“…In India, DTwP-HB-Hib pentavalent vaccine trial showed low reactogenicity, minimal adverse events (AEs), and high level of seroprotective rates [ 8 , 9 ]. A randomized trial in Latin American children has also shown that primary and booster vaccination with a DTwP-HB-Hib combination vaccine showed good seroprotection rate and good persistence of antibodies against all vaccine antigens.…”

Section: Introductionmentioning

confidence: 99%

DTwP-HB-Hib: antibody persistence after a primary series, immune response and safety after a booster dose in children 18–24 months old

et al. 2018

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BackgroundThe new combination of DTwP-HB-Hib vaccines has been developed in Indonesia following World Health Organization (WHO) recommendation and integrated into national immunization program. The aims of the study were to measure 1) antibody persistence 12–18 months after a primary series, 2) immune response and safety after a booster dose of DTwP-HB-Hib.MethodsThis was a multi-center, open-labeled, prospective, interventional study. Subjects who had received complete primary dose of DTwP-HB-Hib vaccine from the previous phase III trial were recruited in this trial. Subjects were given one dose of DTwP-HB-Hib (Pentabio®) booster at age 18–24 months old. Diphtheria, tetanus, pertussis, hepatitis B, Hemophilus influenza type B antibodies were measured before and after booster to determine antibody persistence and immune response. Vaccine adverse events were assessed immediately and monitored until 28 days after the booster recorded with parent’s diary cards.ResultsThere were 396 subjects who completed the study. Increased proportion of seroprotected subjects from pre-booster to post-booster were noted in all vaccine antigens: 74.5 to 99.7% for diphtheria; 100 to 100% for tetanus; 40.4 to 95.5% for pertussis; 90.2 to 99.5% for hepatitis B; and 97.7 to 100% for Hib. Common systemic adverse events (AEs) were irritability (23.7–25%) and fever (39.9–45.2%). Local AEs such as redness, swelling, and induration were significantly less common in the thigh group (7.7, 11.3, and 7.1%) than in the deltoid group (28.9, 30.7, and 25%) (P < 0.001). Most AEs were mild and resolved spontaneously within three-day follow-up period.ConclusionsBooster of DTwP-HB-Hib vaccine at age 18–24 months is required to achieve and maintain optimal protective antibody. The vaccine is safe and immunogenic to be used for booster vaccination.Trial registrationNCT02095314 (retrospectively registered, March 24, 2014).

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A phase III randomized, controlled study to assess the immunogenicity and tolerability of DTPw–HBV–Hib, a liquid pentavalent vaccine in Indian infants

Cited by 21 publications

References 15 publications

A phase III single arm, multicenter, open-label study to assess the immunogenicity and tolerability of a pentavalent DTwP–HepB–Hib vaccine in indian infants

A phase III single arm, multicenter, open-label study to assess the immunogenicity and tolerability of a pentavalent DTwP–HepB–Hib vaccine in indian infants

The Comparison of the adverse events of Pentavalent and DPT vaccines in 2-6 months infants in Iran: A national study

DTwP-HB-Hib: antibody persistence after a primary series, immune response and safety after a booster dose in children 18–24 months old

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