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Safety of PENTAXIM® Given as a Three-Dose Primary Vaccination at 2, 3, and 4 Months of Age in Infants in China

NCT01491087 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2013-03-29

No results posted yet for this study

Summary

The study will assess the safety of Pentaxim® vaccine as a three-dose primary vaccination at 2, 3, and 4 months of age in order to meet the regulatory requirements for the license renewal as for any other product registered in China, and to generate additional clinical data using the three-dose primary vaccination schedule in some other Chinese provinces.

Primary Objective

* To describe the safety after administration of PENTAXIM® at 2, 3, and 4 months of age in the study population.

Conditions

  • Diphtheria
  • Tetanus
  • Pertussis
  • Polio

Interventions

BIOLOGICAL

DTacP IPV//PRP~T combined vaccine: PENTAXIM®

0.5 mL, Intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur SA

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Days
Max Age
74 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2012-07-31
Completion
2012-12-31

Countries

  • China

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 NCT01491087 on ClinicalTrials.gov