NCT01025544

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
846

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

December 8, 2011

Status Verified

December 1, 2011

Enrollment Period

3 months

First QC Date

December 2, 2009

Last Update Submit

December 7, 2011

Conditions

Haemophilus Influenzae Type b (Hib) Infection

Keywords

Haemophilus influenzae type b (Hib)VaccineBooster

Outcome Measures

Primary Outcomes (1)

  • Anti-PRP antibody levels at day 31 post booster

    31 days after vaccination

Secondary Outcomes (1)

  • Solicited local and systemic reactions, AEs, and SAEs

    30 days post vaccination

Study Arms (2)

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

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

Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines.

Arm 1
Hiberix (Haemophilus influenzae type b (Hib) vaccine)BIOLOGICAL

Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines.

Arm 2

Eligibility Criteria

Age12 Months - 18 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Hebei Province, China

Location

MeSH Terms

Conditions

Haemophilus InfectionsInfections

Interventions

VaccinesHiberix

Condition Hierarchy (Ancestors)

Pasteurellaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Biological ProductsComplex Mixtures

Study Officials

  • Novartis Basel

    41 61 324 1111

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2009

First Posted

December 3, 2009

Study Start

September 1, 2009

Primary Completion

December 1, 2009

Study Completion

April 1, 2010

Last Updated

December 8, 2011

Record last verified: 2011-12

Locations

CN(1)