MedTrace Logo

Immunogenicity and Safety of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 13-59 Months Old Healthy Children

NCT01125527 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2016-12-01

No results posted yet for this study

Summary

This study will evaluate the safety and immunogenicity of single dose of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 13-59 months of age.

Conditions

  • Haemophilus Influenzae Type b (Hib) Infection

Interventions

BIOLOGICAL

Monovalent glyco-conjugated vaccine against Haemophilus influenzae type b (Hib)

a single dose was administered

BIOLOGICAL

Tetanus toxoid polysaccharide-conjugated vaccine against Haemophilus influenzae type b (Hib)

a single dose was administered

Sponsors & Collaborators

  • Novartis Vaccines

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
13 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2009-10-31
Completion
2010-04-30

Countries

  • China

More Related Trials

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 NCT01125527 on ClinicalTrials.gov