Immunogenicity and Safety of a Monovalent Glycoprotein-Co... | NCT01125527

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

NCT01125527

Sponsor

Novartis Vaccines

Status

Completed

Last Update Posted

Dec 1, 2016Estimated

Enrollment

700Actual

Phase

Phase 3

Conditions

Haemophilus Influenzae Type b (Hib) Infection

Interventions

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

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Official Title

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

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Oct 2009Actual

Completion Date

Apr 2010Actual

First Submitted Date

May 14, 2010

First Submission Date that Met QC Criteria

May 17, 2010

First Posted Date

May 18, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 30, 2016

Last Update Posted Date

Dec 1, 2016Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

700Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Active Comparator		Biological: Monovalent glyco-conjugated vaccine against Haemophilus influenzae type b (Hib)
Arm 2	Active Comparator		Biological: Tetanus toxoid polysaccharide-conjugated vaccine against Haemophilus influenzae type b (Hib)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Monovalent glyco-conjugated vaccine against Haemophilus influenzae type b (Hib)	Biological	a single dose was administered	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anti-PRP antibody levels at day 31 post last vaccination		30 days after last vaccination

Secondary Outcomes

Measure	Description	Time Frame
Solicited local and systemic reactions, AEs, and SAEs		30 days post last vaccination

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Months

Maximum Age

59 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D006192	Haemophilus Infections
D007239	Infections

ID	Term
D016871	Pasteurellaceae Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses