Status:

COMPLETED

Immunogenicity and Safety of a Booster Dose of Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 365-569 Days Old Healthy Infants

Lead Sponsor:

Novartis Vaccines

Conditions:

Haemophilus Influenzae Type b (Hib) Infection

Eligibility:

All Genders

365-569 years

Phase:

PHASE3

Brief Summary

This study will evaluate the safety and immunogenicity of booster dose of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 365-569 days of age

Eligibility Criteria

Inclusion

  • Infants 365-569 days of age.

Exclusion

  • Subjects who already received a booster dose of Hib vaccine.
  • History of serious reaction(s) following vaccination.
  • Any vaccination within 7 days of study vaccination.
  • Known or suspected immune impairment.

Key Trial Info

Start Date :

October 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2011

Estimated Enrollment :

660 Patients enrolled

Trial Details

Trial ID

NCT01226953

Start Date

October 1 2010

End Date

March 1 2011

Last Update

December 30 2011

Active Locations (1)

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1

Hebei Province, China