Assessment of safety and immunogenicity of two different lots of diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae type b vaccine manufactured using small and large scale manufacturing process

Sharma, Hitt; Patil, Vishwanath; Lalwani, Sanjay; Manglani, Mamta; Ravichandran, Latha; Kapre, Subhash V.; Jadhav, Suresh; Parekh, Sameer; Ashtagi, Girija S; Malshe, Nandini; Palkar, Sonali; Wade, Minal; Arunprasath, Thasma Santhanakrishnan; Jayapalan, Dinesh Kumar; Shewale, Sunil

doi:10.1016/j.vaccine.2011.11.067

Cited by 14 publications

(14 citation statements)

References 16 publications

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“…10 Another study also used pentavalent vaccines at one month-intervals in 608 infants aged 6 weeks and showed anti-PRP results similar to our study: 100% protection for short-term protection (> 0.15µg/mL) and 95% for long-term protection (> 1 µg/mL). 11 Furthermore, another Indian study in 165 infants at 6, 10, and 14 weeks of age found results similar to our study: at one month after the third vaccination, percentages of infants achieving predefined protective antibody levels were 99% diphtheria; 100% tetanus; 98% hepatitis B; 100% Hib short-term (≥ 0.15 µg/mL); 95% Hib long-term (≥ 1.0 µg/mL) protection; and 99% for pertussis (relevant immune response).…”

Section: Discussionsupporting

confidence: 86%

The immunogenicity and safety of the new, Indonesian DTwP-HB-Hib vaccine compared to the DTwP/HB vaccine given with the Hib vaccine

Bachtıar

Rusmil

Sudigdoadi

et al. 2017

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Section: Discussionsupporting

confidence: 86%

The immunogenicity and safety of the new, Indonesian DTwP-HB-Hib vaccine compared to the DTwP/HB vaccine given with the Hib vaccine

Bachtıar

Rusmil

Sudigdoadi

et al. 2017

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“…11 In addition, Hla et al used a pentavalent vaccine given in 1-month intervals to 608 infants aged 6 weeks and showed similar results to ours: 100% short-term protection (anti-PRP > 0.15 µg/mL) and 95% long-term protection (anti-PRP > 1 µg/mL). 12 Another Indian study in 165 infants at 6, 10, and 14 weeks of age also found similar results to our study: at one month after the third vaccination, the percentages of infants who achieved the predefined protective antibody levels were 100% Hib short-term (≥ 0.15 µg/mL) and 95% Hib long-term (≥ 1.0 µg/mL) protection.…”

Section: Discussionsupporting

confidence: 78%

The quantity and quality of anti-PRP induced by the new Indonesian DTwP-HB-Hib vaccine compared to the Hib vaccine given with the DTwP-HB vaccine

Bachtıar

Rusmil

Sudigdoadi

et al. 2018

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Background A phase II study of DTwP-HB-Hib vaccine compared to Hib (monovalent) vaccine given simultaneously with DTwP-HB vaccine has been done following the success of phase I study in infants, where the new DTwP-HB-Hib has excellent safety profiles and antibody responses in infants. Objective To evaluate the titer (quantity), avidity, and bactericidal capacity (quality of anti-polyribosylribitol phosphate/anti-PRP), of a new combined Bio Farma DTwP-HB-Hib (pentavalent) vaccine, compared to the Hib monovalent vaccine given simultaneously with the DTwP-HB vaccine (DTwP-HB+Hib). Methods The study was a prospective, randomized, open label, phase II trial. Subjects aged 6-11 weeks were allocated according to the randomization list. The pentavalent group received the DTwP-HB-Hib vaccine, while the monovalent group received the Hib monovalent and DTwP-HB vaccines separately. Immunizations were given in three doses with 28-day intervals. Blood specimens were taken before the first dose and 28 days after the last dose. We evaluated anti-PRP titers quantity (geometric mean antibody concentration/GMC) and seroprotection), followed by avidity and bactericidal (quality) testing. Titer and avidity of anti-PRP were tested using a modified version of the improved Phipps ELISA. Bactericidal capacity was evaluated using a Hib killing assay. Immune responses against other antigens in the vaccine were reported separately. Results One hundred five subjects in the pentavalent group and 106 subjects in the Hib monovalent group were tested for anti-PRP titers. Only 102 specimens for each group were available for bactericidal testing, due to insufficient volume for testing. Both vaccines induced similar anti-PRP titers, for GMC and seroprotection. Avidity increases were 82.9% and 76.4% in the pentavalent and Hib monovalent groups, respectively. Bactericidal activities were 94.1% and 89.2%, respectively. Both avidity and bactericidal activity were not significantly different between groups. Conclusion DTwP-HB-Hib vaccine induced anti-PRP quantity

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“…Although advances in medicine have made vaccines reliably more effective with minimal adverse events, no vaccine can be found that is free from unwanted adverse events [ 11 ]. As the immunization schedule for Hib is similar to that of the DTP vaccine, it can be easily incorporated into the current immunization program [ 14 ]. There has been no report of incompatibility between the Hib vaccine and the DTP and hepatitis B vaccines.…”

Section: Discussionmentioning

confidence: 99%

Adverse events following immunization with pentavalent vaccine: experiences of newly introduced vaccine in Iran

et al. 2017

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BackgroundThe most important factors that affect the incidence of vaccine-related complications are the constituent biological components of the vaccine, injection site reactions, age and sex. The aim of this study is to determine the incidence rate of adverse events following immunization with pentavalent vaccine (DTPw-Hep B-Hib (PRP-T) vaccine (pentavac) (adsorbed) is manufactured by Serum Institute of India ltd), which was introduced in Iran in November 2014. It is important to monitor vaccine-related adverse events because of the role of vaccine safety in immunization program success.MethodsThis study was a mixed cohort study that included 1119 children less than 1 year of age. In 2015, the children were referred to Hamadan health centers to receive pentavalent vaccine at 2, 4 and 6 months of age. The data were collected from the parents of the children using a questionnaire that was administered either face-to-face or by telephone. The cumulative incidence of side effects and risk ratio was reported with 95% confidence intervals (CI). Chi-squared tests and logistic regressions were used to investigate the association between the variables.ResultsThe cumulative incidence rate of pentavalent-related adverse events during 48 h following immunization was estimated to be 15.8% for swelling, 10.9% for redness, 44.2% for pain, 12.6% for mild fever, 0.1% for high fever, 20.0% for drowsiness, 15.0% for loss of appetite, 32.9% for irritability, 4.6% for vomiting and 5.5% for persistent crying. There is no evidence for the occurrence of convulsion and encephalopathy among children who receive pentavalent vaccines.ConclusionFurther large studies with long time follow up are required to address rare events include convulsions, encephalopathy or persistent crying. However, Findings urge immunization programs to use pentavalent vaccinations and to continue implementing the current immunization program in children under 1 year of age.

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Assessment of safety and immunogenicity of two different lots of diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae type b vaccine manufactured using small and large scale manufacturing process

Cited by 14 publications

References 16 publications

The immunogenicity and safety of the new, Indonesian DTwP-HB-Hib vaccine compared to the DTwP/HB vaccine given with the Hib vaccine

The immunogenicity and safety of the new, Indonesian DTwP-HB-Hib vaccine compared to the DTwP/HB vaccine given with the Hib vaccine

The quantity and quality of anti-PRP induced by the new Indonesian DTwP-HB-Hib vaccine compared to the Hib vaccine given with the DTwP-HB vaccine

Adverse events following immunization with pentavalent vaccine: experiences of newly introduced vaccine in Iran

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