NCT02560272

Brief Summary

The study will evaluate the safety and immunogenicity of a haemophilus influenzae type b conjugate vaccine (Hib) in Healthy Children 2 Months to 5 Years of Age who have not been previously immunized with a Hib vaccine. Children 2 to 5 months of age will receive 3 doses of Hib vaccine, Children 6 to 11 months of age will receive 2 doses of Hib vaccine, Children 1 to 5 years of age will receive 1 dose of Hib vaccine, with each dose given approximately 1 month apart.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,560

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2014

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 19, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 25, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

September 25, 2015

Status Verified

September 1, 2015

Enrollment Period

1.2 years

First QC Date

September 19, 2015

Last Update Submit

September 24, 2015

Conditions

Haemophilus Influenzae Type b Infections

Keywords

vaccinehaemophilus influenzae type b

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 0.15 Microgram Per Milliliter (µg/mL) and ≥ 1.0 µg/mL

    28 days after last dose of primary vaccination

Secondary Outcomes (3)

  • Number of Subjects With Any Solicited Local and General Symptoms

    Within 7 days after any vaccination

  • Number of Subjects With Any Unsolicited Adverse Events (AEs)

    Within 28 days after any vaccination

  • Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations

    28 days after last dose of primary vaccination

Study Arms (2)

Minhai-HIB

EXPERIMENTAL

Participants at age 1 to 5 years of enrollment will receive one dose on Hib vaccine. Participants at age 6 to 11 months of enrollment will receive 2 doses on Hib vaccine at one months apart. Participants at age 2 to 5 months of enrollment will receive 3 doses on Hib vaccine at one months apart.

Biological: Minhai-HIB

Act-HIB®

ACTIVE COMPARATOR

Participants at age 1 to 5 years of enrollment will receive one dose on Hib vaccine. Participants at age 6 to 11 months of enrollment will receive 2 doses on Hib vaccine at one months apart. Participants at age 2 to 5 months of enrollment will receive 3 doses on Hib vaccine at one months apart.

Biological: Act-HIB®

Interventions

Minhai-HIBBIOLOGICAL

0.5ml, intramuscular

Minhai-HIB
Act-HIB®BIOLOGICAL

0.5ml, intramuscular

Act-HIB®

Eligibility Criteria

Age2 Months - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy permanent residence 2 months to 5 years old.
  • Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study.
  • Subjects and parent/guardian able to attend all scheduled visits and comply with all study procedures.
  • Axillary temperature ≤37.0 ℃.

You may not qualify if:

  • History of Haemophilus influenzae type b infection or vaccination of Haemophilus influenzae type b conjugate vaccine.
  • Allergic history or any SAE after vaccination, such as allergy, urticaria, dyspnea, angioedema, celialgia.
  • Receipt of blood or blood-derived products in the 3 months preceding vaccination
  • Participation in another clinical study investigating a vaccine, drug in the 30 days preceding vaccination.
  • Receipt of any live virus vaccine in the 15 days preceding vaccination.
  • Receipt of any subunit vaccine and inactivated vaccine in the 7 days before vaccination.
  • Febrile illness (temperature ≥ 38°C) in the 3 days or any acute illness/infection in the 7 days preceding vaccination.
  • Thrombocytopenia.
  • History of treatment for thyroid gland disease.
  • Functional or anatomic asplenia.
  • History of eclampsia, epilepsy, encephalopathy and mental disease or family disease.
  • Any condition that, in the judgment of investigator, may affect trial assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henan Provincial Center for Disease Control and Prevention

Zhengzhou, Henan, China

RECRUITING

MeSH Terms

Conditions

Haemophilus Infections

Interventions

Hiberix

Condition Hierarchy (Ancestors)

Pasteurellaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • shengli xia

    Henan Provincial Center for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guifan Li

CONTACT

86-10-59613591guifan@sohu.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2015

First Posted

September 25, 2015

Study Start

September 1, 2014

Primary Completion

December 1, 2015

Study Completion

June 1, 2016

Last Updated

September 25, 2015

Record last verified: 2015-09

Locations

CN(1)