NCT03703336

Phase III Study of Liquid Formulation of ROTAVIN

A Phase III, Randomized, Partially Double- Blind, Active Control Study to Compare the Immunogenicity and Safety of a Liquid Formulation of ROTAVIN With the Currently Licensed Frozen Formulation of the Vaccine (ROTAVIN-M1), in Healthy Vietnamese Infants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 825 (actual)
• Sponsor: Center for Research and Production of Vaccines and Biologicals, Vietnam · Other Government
• Sex: All
• Age: 60 Days – 91 Days
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Diarrhea
• Diarrhea Rotavirus

Interventions

Type	Name	Description
BIOLOGICAL	ROTAVIN (liquid formulation)	Live attenuated human rotavirus vaccine containing ≥ 2x10\^6 plaque forming units (PFU) of strain G1P\[8\] per dose of 2 mL.
BIOLOGICAL	ROTAVIN-M1 (frozen formulation)	Live attenuated human rotavirus vaccine containing ≥ 2x10\^6 PFU of strain G1P\[8\] per dose of 2 mL.

Timeline

• Start date: 2019-03-16
• Primary completion: 2020-01-08
• Completion: 2020-01-08
• First posted: 2018-10-11
• Last updated: 2021-01-25
• Results posted: 2021-01-25

Locations

2 sites across 1 country: Vietnam