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The Transparent Safety Study of the 5 in 1 (DTwP-rHepB-Hib) Combination Vaccine Produced by the Indian Serine Institute in Children of Viet Nam Healthy From 6 to 12 Weeks of Age in a 3-dose Regimen, the Interval Between Doses is 4 Weeks

NCT03931239 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 222

Last updated 2019-05-03

No results posted yet for this study

Summary

The objective of this study is to evaluate safety and tolerability of Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus influenzae type b Conjugate Vaccine Adsorbed in Vietnamese infants aged 6-12 weeks. This is an open label, single group, bridging study.

Conditions

  • Diphtheria
  • Tetanus
  • Pertussis
  • Hepatitis B
  • Haemophilus Influenzae Type B

Interventions

BIOLOGICAL

Study subjects will be vaccinated with 3 (three) vaccine doses. The first vaccine will be administered intramuscularly starting at 6-12 weeks of age followed by two doses at four-week interval

An openlabel, multicentric, bridging study to assess the safety of Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus influenzae type b Conjugate Vaccine (Adsorbed) manufactured by Serum Institute of India Pvt. Ltd in Vietnamese infants aged 6-12 weeks, given as a 3-dose regime, with 4 week intervals between the doses

Sponsors & Collaborators

  • Vietstar Biomedical Research

    collaborator INDUSTRY

  • Vabiotech

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Weeks
Max Age
12 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2018-06-30
Completion
2018-07-30

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 NCT03931239 on ClinicalTrials.gov