Response to Rotavirus Vaccine in Infants in Ho Chi Minh City in Vietnam

NCT03587389 | Completed Phase 4 DMC

• 1 other identifier: 21EN
• Study Type: interventional
• Target: 818
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to measure the effect of host human genetics on the resulting immunological responses and long-term protection following rotavirus immunization of a study population of infants in Ho Chi Minh City, Vietnam. The secondary objectives are to assess the temporal immunological responses following rotavirus vaccination, and to investigate the role of maternally derived antibodies, and other factors that could potentially affect immunological responses following rotavirus vaccination. Also to assess infecting rotavirus genotypes in the vaccine failure cases.

Conditions

Rotavirus; Diarrhea

Keywords

Rotavirus; Vaccine; Diarrhea; Host genetics

Outcome Measures

Primary Outcomes (1)

• The rotavirus vaccine failure events during the time period from recruitment to 18 months of age.

  The primary endpoint is to measure the proportion of rotavirus vaccine failure events during the time period from recruitment to 18 months of age after the first dose of vaccination.

  from the recruitment to 18 months of age after the first dose of vaccination

Secondary Outcomes (2)

• Quantification of the antibody response following immunization

  data collected during 7 site visits (Visit 1: Rotarix Dose 1, Visit 2: 2-3 after Visit 1, Visit 3: 28-37 days after Visit 1, Visit 4: 2-3 days after Visit 3, Visit 5: 6 months old, Visit 6: 12 months old, Visit 7: 18 months old)

• Assessment of infecting rotavirus genotypes in vaccine failure cases

  from the recruitment to 18 months of age after the first dose of vaccination

Study Arms (1)

Rotavirus vaccine

EXPERIMENTAL

The Rotarix vaccine package consist of 1.5 ml of oral suspension in a pre-filled oral applicator (type I glass) with a plunger stopper (rubber butyl) and a protective tip cap (rubber butyl) in pack sizes of 1. The vaccination course consists of two doses. The first dose may be administered from the age of 6 weeks. There should be an interval of at least 4 weeks between doses. The vaccination course should preferably be given before 16 weeks of age, but must be completed by the age of 24 weeks. Rotarix is for oral use only and should under no circumstancies be injected. All participating infants will receive two doses of Rotarix vaccine following the standard Rotarix immunization protocol.

Biological: Rotarix vaccine

Interventions

Rotarix vaccine BIOLOGICAL

In this study, the 1st dose of Rotarix vaccine will be administered when infants are at ages between weeks 8-9 and the 2nd dose is 28-37 days after the 1st dose, which means that there is an interval of 28-37 days or 4-5 weeks between doses. A reminding call will be set at about 4 weeks after the 1st dose to remind parents to bring their children back to Hung Vuong Hospital for the 2nd dose of Rotarix to ensure the completion of the 2nd dose of Rotarix vaccine.

Rotavirus vaccine

Eligibility Criteria

• Age: 8 Weeks - 9 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants (both males and females) between 8 and 9 weeks (i.e. approximately 2 months) of age who are attending Hung Vuong Hospital to receive their standard EPI vaccinations.
• Currently registered residents of Districts 5 (where Hung Vuong Hospital is located) or 1, 6, 8, 10, or 11 (districts that are neighbouring district 5) in Ho Chi Minh city, with no specific intention of relocating in the next 12 months.
• Informed consent to be enrolled in the study and comply with study procedures, including host genetic studies.

You may not qualify if:

• Refusal of consent.
• Parent/ guardian under the age of 18.
• Premature (i.e. gestation period \<37 weeks).
• Infants who have already been immunized with either a rotavirus vaccine or the standard 2-month EPI vaccinations.
• History of hypersensitivity to any components of the vaccine or adverse vaccine event.
• History of intussusception or congenital malformation of the gastrointestinal tract in the child that is likely to predispose child to intussusception.
• History of severe combined immunodeficiency disease (SCID), acquired immune deficiency syndrome (AIDS) or Human immunodeficiency virus (HIV) positivity, or other known immunodeficiency syndromes that may place the child at risk during immunisation.

Sponsors & Collaborators

• Oxford University Clinical Research Unit, Vietnam: lead
• Hung Vuong Hospital: collaborator
• Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam: collaborator
• Children's Hospital Number 1, Ho Chi Minh City, Vietnam: collaborator
• Wellcome Sanger Institute: collaborator

Study Sites (1)

Hung Vuong Hospital

Ho Chi Minh City, 700000, Vietnam

Location

MeSH Terms

Conditions

Diarrhea

Interventions

RIX4414 vaccine

Condition Hierarchy (Ancestors)

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

Study Officials

• Stephen Baker, Professor

  Oxford University Clinical Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: July 16, 2018
• Study Start: March 19, 2019
• Primary Completion: June 30, 2022
• Study Completion: August 8, 2022
• Last Updated: November 14, 2022

Record last verified: 2022-11

Locations

VN (1)