Study in Toddlers (12-18 Months) Comparing a Booster Dose... | NCT01025544

Studies
Study in Toddlers (12-18 Months) Comparing a Booster Dose of Vaxem Hib and Hiberix Vaccines for the Prevention of Haemophilus Influenzae Type b Infections in China

NCT01025544

Sponsor

Novartis Vaccines

Status

Completed

Last Update Posted

Dec 8, 2011Estimated

Enrollment

846Actual

Phase

Phase 3

Conditions

Haemophilus Influenzae Type b (Hib) Infection

Interventions

Vaxem Hib (Haemophilus influenzae type b (Hib) vaccine)
Hiberix (Haemophilus influenzae type b (Hib) vaccine)

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

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

Sep 2009

Primary Completion Date

Dec 2009Actual

Completion Date

Apr 2010Actual

First Submitted Date

Dec 2, 2009

First Submission Date that Met QC Criteria

Dec 2, 2009

First Posted Date

Dec 3, 2009Estimated

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

Dec 7, 2011

Last Update Posted Date

Dec 8, 2011Estimated

Description Module

Brief Summary

This study will evaluate the safety and immunogenicity of booster doses of the two vaccines used to prevent Haemophilus influenzae type b infections in children 12-18 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

846Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Active Comparator		Biological: Vaxem Hib (Haemophilus influenzae type b (Hib) vaccine)
Arm 2	Active Comparator		Biological: Hiberix (Haemophilus influenzae type b (Hib) vaccine)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vaxem Hib (Haemophilus influenzae type b (Hib) vaccine)	Biological	Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines.	Arm 1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Toddlers 12-18 months of age who have previously participated in study M37P2.

Exclusion Criteria:

Prior Hib booster administration.
History of serious reaction(s) following vaccination.
Vaccination within 14 days of study vaccination.
Known or suspected immune impairment.
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

12 Months

Maximum Age

18 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Novartis Basel	41 61 324 1111	Study Chair

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

MeSH Terms

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

ID	Term
D001688	Biological Products
D045424	Complex Mixtures