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Clinical Trials/NCT01125527
NCT01125527
Completed
Phase 3

A Phase III Observer-blind, Randomized, Controlled, Single-coordinating Center Study to Investigate Immunogenicity and Safety of a Monovalent Glycoprotein-conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 13-59 Months Old Healthy Children in China, According to the Recommended Regimen of 1 Dose

Novartis Vaccines0 sites700 target enrollmentAugust 2009
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ConditionsHaemophilus Influenzae Type b (Hib) Infection

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Haemophilus Influenzae Type b (Hib) Infection
Sponsor
Novartis Vaccines
Enrollment
700
Primary Endpoint
Anti-PRP antibody levels at day 31 post last vaccination
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
August 2009
End Date
April 2010
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Novartis Vaccines
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Infants 13-59 months of age.

Exclusion Criteria

  • •Prior Hib vaccine administration.
  • •History of serious reaction(s) following vaccination.
  • •Any vaccination within 7 days of study vaccination.
  • •Known or suspected immune impairment.
  • •Premature (before 37th week of gestation) or birth weight less than 2500g
  • •For additional entry criteria please refer to the protocol.

Outcomes

Primary Outcomes

Anti-PRP antibody levels at day 31 post last vaccination

Time Frame: 30 days after last vaccination

Secondary Outcomes

  • Solicited local and systemic reactions, AEs, and SAEs(30 days post last vaccination)

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