Phase III Study of Liquid Formulation of ROTAVIN

Status Completed

Clinical Trial Summary

This study is conducted to demonstrate non-inferiority in the immunogenicity of the liquid formulation of ROTAVIN in comparison to currently licensed frozen formulation of the vaccine (ROTAVIN-M1), 28 days after the second vaccination when administered as two dose series starting at 2-3 months of age. The study will also assess the reactogenicity of the vaccine 7 days after each vaccination and safety from first vaccination up to 4 weeks after the last vaccination.

Clinical Trial Description

The study is designed as a phase III, randomized, partially double-blinded, active controlled study with two groups of infants receiving vaccines at the ratio of 2:1 (liquid formulation of ROTAVIN to frozen formulation ROTAVIN-M1), to compare their immunogenicity and safety. Two doses of vaccine will be administered 8 weeks apart with the first vaccine administration between 60-91 days of age. All childhood vaccines as per the Expanded Program for Immunization of the Government of Vietnam (including Diphtheria, Tetanus, Pertussis, Haemophilus influenzae type b and Hepatitis B vaccine (DTwPHib-HepB), and Oral Polio Vaccine at at 2, 3 and 4 months of age) will be allowed as per the immunization schedule. Active surveillance for vaccine reactogenicity (solicited reactions) over the 7-day period after each vaccination, unsolicited adverse events (AEs) for 4 weeks after each vaccination and serious adverse events (SAEs) including intussusception over the period between first vaccination and four weeks after the last vaccination will be conducted for all infants. This trial will generate immunogenicity and safety data which would be submitted to Ministry of Health in Vietnam for license of new formulation of ROTAVIN vaccine. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03703336
Study type	Interventional
Source	Center for Research and Production of Vaccines and Biologicals, Vietnam
Contact
Status	Completed
Phase	Phase 3
Start date	March 16, 2019
Completion date	January 8, 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT06283784` - Study To Evaluate The Efficacy of a Proprietary Mix of Live Probiotics In The Prophylaxis Of Diarrhea In Adult Patients	N/A
Recruiting	`NCT03851835` - Multi-DOSE Oral Ondansetron for Pediatric Acute GastroEnteritis	Phase 3
Completed	`NCT04003181` - The Pathogenesis of Chronic Diarrhoea After Treatment for Cancer in Cecum and the Ascending Colon	N/A
Completed	`NCT03596827` - The Protective Immune Response to Attenuated Enterotoxigenic Escherichia Coli Infection	N/A
Recruiting	`NCT05372068` - Cement flooRs AnD chiLd hEalth (CRADLE)	N/A
Completed	`NCT03972618` - Evaluation of the Efficacy of Sawyer Point One Filters in Schools and Homes in the Dominican Republic	N/A
Completed	`NCT05207618` - Utility of the Administration of Chesnut and Quebracho Extract for Irritable Bowel Syndrome Diarrhea Predominant	N/A
Not yet recruiting	`NCT05052489` - Registry and Clinical Observation of Children With Diarrhoeal Disease
Completed	`NCT02541695` - Characterization of Resistance Against Live-attenuated Diarrhoeagenic E. Coli	N/A
Completed	`NCT02428647` - Lao Zinc Study: Effects of Two Forms of Daily Preventive Zinc Versus Therapeutic Zinc Supplementation	N/A
Completed	`NCT02197780` - Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD	N/A
Completed	`NCT01968408` - Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children	Phase 3
Completed	`NCT01739231` - Live Attenuated ETEC Vaccine ACE527 With and Without dmLT Adjuvant in Adults	Phase 1/Phase 2
Completed	`NCT01438645` - ScopeGuide-assisted Colonoscopy Versus Conventional Colonoscopy	N/A
Completed	`NCT01371656` - Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation	Phase 3
Terminated	`NCT01472211` - Water-based Zinc Intervention Trial in Zinc Deficient Children	Phase 0
Not yet recruiting	`NCT01382199` - Recombinant Human Lactoferrin Administered Orally for the Prevention of Antibiotic Associated Diarrhea in Adult Patients	Phase 3
Terminated	`NCT01048567` - Efficacy and Safety of Lactobacillus Acidophilus/Rhamnosus Combination for the Prevention of Antibiotic-associated Diarrhea in the Elderly	Phase 2
Completed	`NCT00914225` - Effect of Bednets and a Water Purification Device on HIV Disease Progression Among ART naïve Patients in Kenya	N/A
Completed	`NCT00760851` - Yogurt Study in Children 2-4 Years Old Attending Daycare	Phase 3