A comparison of immunogenicity and safety of indigenously developed liquid (DTwPHB-Hib) pentavalent combination vaccine (Shan 5) with Easyfive (Liq) and Tritanrix + Hiberix (Lyo) in Indian infants administered according to the EPI schedule

Rao, Raman; Dhingra, Mandeep Singh; Bavdekar, Sandeep B; Behera, Narendra; Daga, Subhash R; Dutta, A. K.; Kundu, Ritabrata; Maiya, P. P.; Mishra, Pradeep; Shah, Raju; Shuba, Sankaranarayan; Tibrewala, Vinoo; Pandhi, Shaloo; Rajamani, Arul Mani

doi:10.4161/hv.5.6.7816

Cited by 22 publications

(15 citation statements)

References 5 publications

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“…In the state of Maharashtra, the post-neonatal infant mortality was 5.7 per 1000 in [2005][2006]. 14 This means that in our study with 3 months follow up, perhaps 3-4 deaths were expected. However, we had only one death, thus indicating a healthy vaccinee effect.…”

Section: Discussionmentioning

confidence: 83%

A comparative clinical study to assess safety and reactogenicity of a DTwP-HepB+Hib vaccine

Dalvi

Kulkarni²,

Phadke

et al. 2015

Human Vaccines & Immunotherapeutics

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Hepatitis B and Haemophilus influenzae type b (Hib) infections are major public health problems in developing countries, including India. Hence, combination vaccines containing DTwP, recombinant hepatitis B and Hib conjugate vaccines have been developed. Here, we report a Phase IV study which assessed safety and reactogenicity of a new DTwP-HepBCHib vaccine. Three doses of DTwP-HepBCHib vaccine (Pentavac, Serum Institute of India Ltd) or TritanrixHBCHib (GlaxoSmithKline Beecham) were administered to infants at 6, 10 and 14 weeks of age in 2:1 ratio. The subjects were followed till one month after the third dose for safety assessment. Adverse events were captured in structured diaries and physical examinations were performed on each visit. The study was conducted in 1510 infants. Both vaccines caused injection site local and systemic reactions and the incidence was similar in both the groups. The incidence of local solicited reactions was: tenderness 35.9 %-33.6 %; redness 18.1 %-17.2 %; swelling 23.7 %-22.4 %; induration 12.8 % -13.7 %. The percentage of systemic solicited reactions were: diarrhea 2.2 %-2.2 %; drowsiness 3.3 %-3.4 %; fever 14.0 %-11.2 %; irritability 28.1 %-25.4 %; loss of appetite 6.6 %-5.6 %; persistent crying 17.7 %-15.7 %; vomiting 3.5 %-3.0 %. No serious adverse event was caused by the vaccines. The new DTwP-HepBCHib combination vaccine showed similar safety profile to that of an imported vaccine in Indian infants.

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Section: Discussionmentioning

confidence: 83%

A comparative clinical study to assess safety and reactogenicity of a DTwP-HepB+Hib vaccine

Dalvi

Kulkarni²,

Phadke

et al. 2015

Human Vaccines & Immunotherapeutics

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“…Comparable immune responses were observed for the other three components (D, T, and P) in all groups. 15 Compared to all studies noted above, we found that both our groups had similar results, in terms of immune response, except for anti-HBs. In the DTwP-HB-Hib group, the hepatitis B response reached 99.0% seroprotection after three doses of vaccine, with GMCs of 441.57 mIU/mL, compared to a 96.2% seroprotection rate, with GMCs of 213.84 mIU/mL in the DTwP-HB+Hib group.…”

supporting

confidence: 76%

“…The most frequent systemic event was crying, in 23.34%-25.89%. 15 Compared to other studies, our trial vaccine induced fewer local reactions, but for systemic events, a higher percentage of fever, and fewer other systemic events than other pentavalent vaccines. According to the WHO information sheets for DTP-based vaccines, fever > 38°C and irritability may occur 45-75% of vaccinees, much higher than our findings.1 6 In our study, one child had a complex febrile convulsion, classified as a vaccine reaction.…”

mentioning

confidence: 51%

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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“…They found that 98.32% of subjects in the new pentavalent vaccine trial group had seroprotective anti-PRP-T IgG antibody concentrations of ≥ 0.15 µg/mL, as compared to 100% and 98.94% of subjects in DTwPHB+Hib and the other registered pentavalent vaccine groups, respectively. 15 We found that the avidity increases were not significantly different between the pentavalent and Hib monovalent groups [82.86% vs. 77.14%, respectively (P=0.245)]. In contrast, a German study conducted in 90 infants with an immunization schedule at 3, 4, and 5 months using the DTaP-HB-Hib vaccine compared to separate injections given simultaneously showed significantly lower avidity in the combination vaccine group (P<0.0001).…”

Section: Discussionmentioning

confidence: 43%

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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A comparison of immunogenicity and safety of indigenously developed liquid (DTwPHB-Hib) pentavalent combination vaccine (Shan 5) with Easyfive (Liq) and Tritanrix + Hiberix (Lyo) in Indian infants administered according to the EPI schedule

Cited by 22 publications

References 5 publications

A comparative clinical study to assess safety and reactogenicity of a DTwP-HepB+Hib vaccine

A comparative clinical study to assess safety and reactogenicity of a DTwP-HepB+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

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