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Immunogenicity and lot-to-lot consistency of a ready to use liquid bovine-human reassortant pentavalent rotavirus vaccine (ROTASIIL - Liquid) in Indian infants
- Source :
- Vaccine. 37:2554-2560
- Publication Year :
- 2019
- Publisher :
- Elsevier BV, 2019.
-
Abstract
- A lyophilized bovine-human rotavirus reassortant pentavalent vaccine (BRV-PV, Rotasiil®) was licensed in 2016. A liquid formulation of this vaccine (LBRV-PV, Rotasiil - Liquid) was subsequently developed and was tested for non-inferiority to Rotasiil® and for lot-to-lot consistency.This Phase II/III, open label, randomized study was conducted at seven sites across India from November 2017 to June 2018. Participants were randomized into four arms; Lots A, B, and C of LBRV-PV and Rotasiil® in 1:1:1:1 ratio. Three doses of study vaccines were given at 6, 10, and 14 weeks of age. Blood samples were collected four weeks after the third dose to assess rotavirus IgA antibody levels. Non-inferiority of LBRV-PV to Rotasiil was proven if the lower limit two-sided 95% confidence interval (CI) of geometric mean concentration (GMC) ratio was at least 0.5. Lot-to-lot consistency was proven if 95% CI of the GMC ratios of three lots were between 0.5 and 2. Solicited reactions were collected by using diary cards.Of the 1500 randomized infants, 1436 infants completed the study. The IgA GMC ratio of LBRV-PV to Rotasiil® was 1.19 (95% CI 0.96, 1.48). The corresponding IgA seropositivity rates were 60.41% (57.41, 63.35) and 52.75% (47.48, 57.97). The IgA GMC ratios among the three LBRV-PV lots were: Lot A versus Lot B: 1.34 (1.03, 1.75); Lot A versus Lot C: 1.22 (0.93, 1.60); and Lot B versus Lot C: 0.91 (0.69, 1.19). The 95% CIs for the GMC ratios were between 0.69 and 1.75. The incidence of solicited reactions was comparable across the four arms. Only one serious adverse event of gastroenteritis event in the Rotasiil® group was causally related.The immunological non-inferiority of LBRV-PV against Rotasiil® as well as lot-to-lot consistency of LBRV-PV was demonstrated. LBRV-PV had safety profile similar to Rotasiil®.Clinical Trials.Gov [NCT03474055] and Clinical Trial Registry of India [CTRI/2017/10/010104].
- Subjects :
- Male
Rotavirus
medicine.medical_specialty
030231 tropical medicine
Prevalence
India
Antibodies, Viral
medicine.disease_cause
Rotavirus Infections
law.invention
Pentavalent vaccine
03 medical and health sciences
Immunogenicity, Vaccine
0302 clinical medicine
Randomized controlled trial
law
Internal medicine
Outcome Assessment, Health Care
medicine
Animals
Humans
030212 general & internal medicine
Adverse effect
General Veterinary
General Immunology and Microbiology
business.industry
Incidence (epidemiology)
Vaccination
Age Factors
Rotavirus Vaccines
Public Health, Environmental and Occupational Health
Infant
Rotavirus vaccine
Confidence interval
Gastroenteritis
Infectious Diseases
Molecular Medicine
Cattle
Female
business
Reassortant Viruses
Subjects
Details
- ISSN :
- 0264410X
- Volume :
- 37
- Database :
- OpenAIRE
- Journal :
- Vaccine
- Accession number :
- edsair.doi.dedup.....bab56e9f344a55879cb249cf09ca6d84