Completed PHASE3 INTERVENTIONAL 1-arm NCT00259337

Immunogenicity and Safety of Pentaxim™ in an Indian Population

Immunogenicity and Safety of the Sanofi Pasteur DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) Given as a Three-Dose Primary Vaccination at 6, 10, and 14 Weeks of Age and Followed by a Booster Dose at 18-19 Months of Age in Healthy Infants in India.

Sponsor: Sanofi

Conditions Diphtheria Haemophilus Infections Pertussis Polio Tetanus

Interventions Diphteria/Tetanus/Polio/Acellular Pertussis/Hib vaccine

Updated 5 times since 2017 Last updated: Apr 13, 2012 Started: Feb 28, 2006 Primary completion: Apr 30, 2008 Completion: Dec 31, 2008

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00259337, this PHASE3 trial focuses on Diphtheria and Haemophilus Infections and remains completed. Sponsored by Sanofi, it has been updated 5 times since 2006, reflecting limited change activity. This study is part of the global effort to build evidence for infectious disease interventions.

Status Flow

Change History

5 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3
Jan 2017 — Jun 2018 [monthly]

Completed PHASE3

First recorded

Feb 2006

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Sanofi

Data source: Sanofi

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• New Delhi, India