NCT01761136

Brief Summary

The objective of this study was to evaluate the safety and immunogenicity of Haemophilus influenzae type b vaccine in different injection site.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
680

participants targeted

Target at P75+ for phase_4 healthy

Timeline
Completed

Started Nov 2011

Typical duration for phase_4 healthy

Geographic Reach
1 country

5 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 3, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

March 28, 2013

Status Verified

March 1, 2013

Enrollment Period

1.1 years

First QC Date

January 3, 2013

Last Update Submit

March 27, 2013

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Incidence rate of adverse events of Haemophilus influenzae type b vaccine in different injection site

    one year

Secondary Outcomes (1)

  • Antibody titre of Haemophilus influenzae type b vaccine in different injection site

    one year

Study Arms (2)

Inoculation in upper arm deltoid

ACTIVE COMPARATOR

Inoculation of Hib vaccine of two brands in upper arm deltoid

Biological: Inoculation in upper arm deltoidBiological: Inoculation in vastus lateralis muscle

Inoculation in vastus lateralis muscle

EXPERIMENTAL

Inoculation of Hib vaccine of two brands in vastus lateralis muscle

Biological: Inoculation in upper arm deltoidBiological: Inoculation in vastus lateralis muscle

Interventions

Inoculation in upper arm deltoidBIOLOGICAL

Inoculation of Hib vaccine of two brands in upper arm deltoid

Inoculation in upper arm deltoidInoculation in vastus lateralis muscle
Inoculation in vastus lateralis muscleBIOLOGICAL

Inoculation of Hib vaccine of two brands in vastus lateralis muscle

Inoculation in upper arm deltoidInoculation in vastus lateralis muscle

Eligibility Criteria

Age2 Months - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • participants were under 1 years old, and were in good healthy
  • participants were full-time pregnancy and birth weight were more than 2.5 kg

You may not qualify if:

  • current infectious fever or acute disease
  • a history of hypersensitivity to study vaccine components especially tetanus toxoid
  • a history of allergy, autoimmune, convulsions, seizures heredity disease
  • a history of Hib vaccination or Hib disease
  • a history of congenital deformity, developmental disorders or serious chronic diseases, muscle injection contradiction, and immunosuppressive agents, hormone or immunoglobulin received.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Beijing Huaxin Hospital

Beijing, Beijing Municipality, China

Location

Beijing Chaoyang Women's and Children's Hospital

Beijing, China

Location

Beijing Dongba Hospital

Beijing, China

Location

Cuigezhuang community health service centers

Beijing, China

Location

Xiaohongmen community health service centers

Beijing, China

Location

MeSH Terms

Interventions

Vaccination

Intervention Hierarchy (Ancestors)

Immunotherapy, ActiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative TechniquesPrimary PreventionPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesCommunicable Disease ControlPublic Health PracticePublic HealthEnvironment and Public Health

Study Officials

  • Nianmin Shi

    Beijing Chaoyang District Center for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2013

First Posted

January 4, 2013

Study Start

November 1, 2011

Primary Completion

December 1, 2012

Study Completion

March 1, 2013

Last Updated

March 28, 2013

Record last verified: 2013-03

Locations

CN(5)