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

NCT03587389 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 818

Last updated 2022-11-14

No results posted yet for this study

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

Interventions

BIOLOGICAL

Rotarix vaccine

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.

Sponsors & Collaborators

  • Hung Vuong Hospital

    collaborator OTHER

  • Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam

    collaborator OTHER

  • Children's Hospital Number 1, Ho Chi Minh City, Vietnam

    collaborator OTHER

  • Wellcome Sanger Institute

    collaborator OTHER

  • Oxford University Clinical Research Unit, Vietnam

    lead OTHER

Principal Investigators

  • Stephen Baker, Professor · Oxford University Clinical Research Unit

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Weeks
Max Age
9 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-19
Primary Completion
2022-06-30
Completion
2022-08-08

Countries

  • Vietnam

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03587389 on ClinicalTrials.gov