A Phase III open-label, randomized, active controlled clinical study to assess safety, immunogenicity and lot-to-lot consistency of a bovine-human reassortant pentavalent rotavirus vaccine in Indian infants

Rathi, Niraj; Desai, Sajjad; Kawade, Anand; Venkatramanan, Padmasani; Kundu, Ritabrata; Lalwani, Sanjay; Dubey, Anand Prakash; Rao, J. Venkateswara; Narayanappa, D; Ghildiyal, Radha; Gogtay, Nithya J; Sriram, Damal Kandadai; Palkar, Sonali; Munshi, Renuka; Kang, Gagandeep; Babji, Sudhir; Bavdekar, Ashish; Juvekar, Sanjay; Ganguly, Nupur; Niyogi, Prabal; Uttam, Kheya Ghosh; Rajani, H S; Kondekar, Alpana; Kumbhar, Dipti; Mohanlal, Smilu; Agarwal, Mukesh C; Shetty, Parvan; Antony, Kalpana; Gunale, Bhagwat; Dharmadhikari, Abhijeet; Tang, Yuxiao; Kulkarni, Prasad S.; Flores, Jorge

doi:10.1016/j.vaccine.2018.11.006

Cited by 15 publications

(24 citation statements)

References 15 publications

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“…None of the SAEs was causally related to the vaccine, in both the groups. There were no safety concerns associated with co-administration of oral Rotavirus vaccine, consistent with studies done for concomitant administration of DT based hexavalent 16 and pentavalent 19 vaccines with oral rotavirus vaccines.…”

Section: Discussionsupporting

confidence: 78%

A phase III randomized-controlled study of safety and immunogenicity of DTwP-HepB-IPV-Hib vaccine (HEXASIIL®) in infants

Sharma,

Parekh,

Pujari

et al. 2024

npj Vaccines

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A fully liquid hexavalent containing Diphtheria (D), Tetanus (T) toxoids, whole cell Pertussis (wP), Hepatitis B (Hep B), type 1, 2, 3 of inactivated poliovirus (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (DTwP-HepB-IPV-Hib vaccine, HEXASIIL®) was tested for lot-to-lot consistency and non-inferiority against licensed DTwP-HepB-Hib + IPV in an open label, randomized Phase II/III study. In Phase III part, healthy infants received DTwP-HepB-IPV-Hib or DTwP-HepB-Hib + IPV vaccines at 6, 10 and 14 weeks of age. Blood samples were collected prior to the first dose and 28 days, post dose 3. Non inferiority versus DTwP-HepB-Hib + IPV was demonstrated with 95% CIs for the treatment difference for seroprotection/seroconversion rates. For DTwP-HepB-IPV-Hib lots, limits of 95% CI for post-vaccination geometric mean concentration ratios were within equivalence limits (0.5 and 2). Vaccine was well-tolerated and no safety concerns observed.Clinical Trial Registration – CTRI/2019/11/022052

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Section: Discussionsupporting

confidence: 78%

A phase III randomized-controlled study of safety and immunogenicity of DTwP-HepB-IPV-Hib vaccine (HEXASIIL®) in infants

Sharma,

Parekh,

Pujari

et al. 2024

npj Vaccines

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“…Similarly, a Phase III clinical study was reported for the safety, immunogenicity, and lot-to-lot consistency of 3Ds of RotaSIIL ® with 2Ds of Rotarix ® and a dose of placebo in 6–8-weeks-old Indian infants, who had earlier received HepB and OPV vaccines at birth. The IgA GMC ratios among the lots A, B, and C considered ranged from 0.99 to 1.07 [ 293 ]. In terms of IgA seropositivity to RoVs, there was a 46.98% rate with RotaSIIL ® vs. 31.12% with Rotarix ® [ 293 ].…”

Section: Factors Affecting Rotavirus Vaccine Efficiencymentioning

confidence: 99%

“…The IgA GMC ratios among the lots A, B, and C considered ranged from 0.99 to 1.07 [ 293 ]. In terms of IgA seropositivity to RoVs, there was a 46.98% rate with RotaSIIL ® vs. 31.12% with Rotarix ® [ 293 ]. All forms of reactogenic effects remained the same across the lots and RotaSIIL ® vs. Rotarix ® combined vaccines.…”

Section: Factors Affecting Rotavirus Vaccine Efficiencymentioning

confidence: 99%

Overview of the Development, Impacts, and Challenges of Live-Attenuated Oral Rotavirus Vaccines

Folorunso

Sebolai

2020

Vaccines

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Safety, efficacy, and cost-effectiveness are paramount to vaccine development. Following the isolation of rotavirus particles in 1969 and its evidence as an aetiology of severe dehydrating diarrhoea in infants and young children worldwide, the quest to find not only an acceptable and reliable but cost-effective vaccine has continued until now. Four live-attenuated oral rotavirus vaccines (LAORoVs) (Rotarix®, RotaTeq®, Rotavac®, and RotaSIIL®) have been developed and licensed to be used against all forms of rotavirus-associated infection. The efficacy of these vaccines is more obvious in the high-income countries (HIC) compared with the low- to middle-income countries (LMICs); however, the impact is far exceeding in the low-income countries (LICs). Despite the rotavirus vaccine efficacy and effectiveness, more than 90 countries (mostly Asia, America, and Europe) are yet to implement any of these vaccines. Implementation of these vaccines has continued to suffer a setback in these countries due to the vaccine cost, policy, discharging of strategic preventive measures, and infrastructures. This review reappraises the impacts and effectiveness of the current live-attenuated oral rotavirus vaccines from many representative countries of the globe. It examines the problems associated with the low efficacy of these vaccines and the way forward. Lastly, forefront efforts put forward to develop initial procedures for oral rotavirus vaccines were examined and re-connected to today vaccines.

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“…Safety data generated in this study further support previous evidence that 2 doses of Lyo HRV are well tolerated in infants worldwide, 12,22,24 including in India. 18,25,26 In this study, no intussusception cases were reported following administration of HRV, but one infant who received Liq HRV experienced intestinal obstruction, which was resolved within 4 days from onset. No safety concern was observed for either Liq or Lyo HRV administration during the current study, in line with the favorable benefit/risk profile established for RV vaccines.…”

Section: Discussionmentioning

confidence: 64%

A phase III randomized, open-label, non-inferiority clinical trial comparing liquid and lyophilized formulations of oral live attenuated human rotavirus vaccine (HRV) in Indian infants

Cohet

Cheuvart

Moerman

et al. 2021

Human Vaccines & Immunotherapeutics

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A Phase III open-label, randomized, active controlled clinical study to assess safety, immunogenicity and lot-to-lot consistency of a bovine-human reassortant pentavalent rotavirus vaccine in Indian infants

Cited by 15 publications

References 15 publications

A phase III randomized-controlled study of safety and immunogenicity of DTwP-HepB-IPV-Hib vaccine (HEXASIIL®) in infants

A phase III randomized-controlled study of safety and immunogenicity of DTwP-HepB-IPV-Hib vaccine (HEXASIIL®) in infants

Overview of the Development, Impacts, and Challenges of Live-Attenuated Oral Rotavirus Vaccines

A phase III randomized, open-label, non-inferiority clinical trial comparing liquid and lyophilized formulations of oral live attenuated human rotavirus vaccine (HRV) in Indian infants

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