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Evaluate Safety of ComBe Five (Liquid) in Healthy Vietnamese Children Aged From 8 - 10 Weeks as a 3-dose Series, Interval for Each Dose is 4 Weeks

NCT02904213 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2017-12-18

No results posted yet for this study

Summary

An open label, non-comparative bridging study to evaluate the safety of pentavalent vaccine ComBe Five (Liquid) made in India, in healthy Vietnamese children aged from 8 - 10 weeks as a 3-dose series, interval for each dose is 4 weeks

Conditions

  • Safety, Pentavalent Vaccine

Interventions

BIOLOGICAL

ComBe Five (Liquid)

Sponsors & Collaborators

  • Biological E. Limited

    collaborator UNKNOWN

  • Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-09-16
Primary Completion
2016-12-19
Completion
2017-06-24

Countries

  • Vietnam

Study Locations

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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 NCT02904213 on ClinicalTrials.gov