Phase III Study of Liquid Formulation of ROTAVIN

NCT03703336 | Completed Phase 3 Results DMC

• 2 other identifiers: CVIA 068VX.2018.05
• Study Type: interventional
• Target: 825
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Diarrhea; Diarrhea Rotavirus

Keywords

ROTAVIN; Rotavirus vaccine; Rotavirus; Diarrhea

Outcome Measures

Primary Outcomes (2)

• Geometric Mean Concentration (GMC) of Serum Anti-rotavirus Immunoglobulin A (IgA) Antibodies 28 Days After Second Vaccination

  Serum anti-rotavirus IgA antibodies were measured using a validated enzyme linked immunosorbent assay (ELISA) at the Cincinnati Children's Hospital Medical Center (CCHMC), Division of Infectious Diseases in Cincinnati, Ohio USA.

  Day 85 (28 days after the second vaccination)

• Number of Participants With Solicited Reactions Within 7 Days of Vaccination

  Solicited post-vaccination reactogenicity included fever, diarrhea, vomiting, decreased appetite, irritability, and decreased activity level during the seven-day period after each vaccination. Parents were asked to record reactions on a post-immunization diary card. Solicited reactions were graded for severity on a scale from mild to severe based on the level of symptoms.

  7 days after each vaccination (Days 1 to 8 and 57 to 64)

Secondary Outcomes (5)

• Percentage of Participants With Seroconversion 28 Days After the Second Vaccination

  28 days after the second vaccination (Day 85)

• Percentage of Participants With Seropositivity at Baseline and 28 Days After the Second Vaccination

  Baseline (Day 1) and at 28 days after the second vaccination (Day 85)

• Number of Participants With Immediate Adverse Events (AEs)

  Within 30 minutes after each vaccination on Day 1 and Day 57

• Number of Participants With Unsolicited Adverse Events

  From vaccination through 28 days after each dose (Days 1 to 28 and 57 to 85)

• Number of Participants With Serious Adverse Events Including Intussusception

  From first vaccination through 28 days after the last vaccination; 85 days

Study Arms (2)

ROTAVIN Liquid Formulation

EXPERIMENTAL

Participants received two doses of ROTAVIN liquid formulation vaccine orally 8 weeks apart with the first dose administered at 60-91 days of age.

Biological: ROTAVIN (liquid formulation)

ROTAVIN-M1 Frozen Formulation

ACTIVE COMPARATOR

Participants received two doses of ROTAVIN-M1 frozen formulation vaccine orally 8 weeks apart with the first dose administered at 60-91 days of age.

Biological: ROTAVIN-M1 (frozen formulation)

Interventions

ROTAVIN (liquid formulation) BIOLOGICAL

Live attenuated human rotavirus vaccine containing ≥ 2x10\^6 plaque forming units (PFU) of strain G1P\[8\] per dose of 2 mL.

ROTAVIN Liquid Formulation

ROTAVIN-M1 (frozen formulation) BIOLOGICAL

Live attenuated human rotavirus vaccine containing ≥ 2x10\^6 PFU of strain G1P\[8\] per dose of 2 mL.

ROTAVIN-M1 Frozen Formulation

Eligibility Criteria

• Age: 60 Days - 91 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy infants as established by medical history and clinical examination before entering the study.
• Age: 60-91 days (both days inclusive) at the time of enrollment.
• Parental/legally acceptable representative ability and willingness to provide written informed consent.
• Parent/legally acceptable representative who intends to remain in the area with the child during the study period.

You may not qualify if:

• Concurrent participation in another clinical trial at any point throughout the entire time frame for this study.
• Presence of significant malnutrition (weight-for-height z-score \< -3 SD median)
• Presence of any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, immunological, dermatological, neurological, cancer, or autoimmune disease) as determined by medical history and / or physical examination which would compromise the participant's health or is likely to result in nonconformance to the protocol.
• History of congenital abdominal disorders, intussusception, or abdominal surgery.
• Known or suspected impairment of immunological function based on medical history and physical examination.
• Household contact with an immunosuppressed individual or pregnant woman.
• Prior receipt of rotavirus or an intent to receive this vaccine from outside of the study center during study participation.
• Prior receipt of Expanded Program on Immunization (EPI) vaccination during past 7 days or plan to receive them within next 7 days.
• A known sensitivity or allergy to any components of the study vaccine.
• History of allergy to antibiotic kanamycin.
• Clinically detectable significant congenital or genetic defect.
• History of persistent diarrhea (defined as diarrhea that lasts 14 days or longer).
• Receipt of immunoglobulin therapy and / or blood products since birth or planned administration during the study period.
• History of chronic administration (defined as more than 14 days) of immunosuppressants including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study.
• Any medical condition in the parent/legally acceptable representative or infant which, in the judgment of the Investigator, would interfere with or serves as a contraindication to protocol adherence.

Sponsors & Collaborators

• Center for Research and Production of Vaccines and Biologicals, Vietnam: lead
• PATH: collaborator
• National Institute of Hygiene and Epidemiology, Vietnam: collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator

Study Sites (2)

CDC Nam Dinh

Nam Định, 10000, Vietnam

Location

CDC Quang Ninh

Quang Ninh, 10000, Vietnam

Location

Related Publications (1)

• Thiem VD, Anh DD, Ha VH, Hien ND, Huong NT, Nga NT, Thang TC, McNeal MM, Meyer N, Pham HL, Huong NM, Gompana G, Cassels F, Tang Y, Flores J, Rathi N. Safety and immunogenicity of two formulations of rotavirus vaccine in Vietnamese infants. Vaccine. 2021 Jul 22;39(32):4463-4470. doi: 10.1016/j.vaccine.2021.06.056. Epub 2021 Jul 1.

  PMID: 34218961 DERIVED

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Nguyen Thuy Huong, Ph.D, Vice Director
• Organization: POLYVAC

huong72us@yahoo.com

+84 912514309

Study Officials

• Niraj Rathi, MD

  PATH India

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Eligible infants will be randomized to receive either ROTAVIN or ROTAVIN-M1 vaccines in the ratio of 2:1.

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: October 11, 2018
• Study Start: March 16, 2019
• Primary Completion: January 8, 2020
• Study Completion: January 8, 2020
• Last Updated: January 25, 2021
• Results First Posted: January 25, 2021

Record last verified: 2020-11

Locations

VN (2)