NCT02764671

Brief Summary

The purpose of this study is to further evaluate the immunogenicity and safety of 10μg/0.5ml Recombinant Hepatitis B Vaccines(Saccharomyces Cerevisiae) in the Healthy Neonates.

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
5,000

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2015

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

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

May 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 4, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

May 6, 2016

Status Verified

May 1, 2016

Enrollment Period

5.3 years

First QC Date

May 4, 2016

Last Update Submit

May 5, 2016

Conditions

HepatitisHepatitis BLiver DiseasesDigestive System Diseases

Keywords

recombinant hepatitis B vaccinesafetyimmunogenicity

Outcome Measures

Primary Outcomes (1)

  • Number of subjects with adverse events

    Within 30 days after hepatitis B vaccination

Secondary Outcomes (4)

  • Geometric mean titer of anti-hepatitis B virus surface antigen antibody

    The 30th day after whole course of hepatitis B vaccination

  • Geometric mean titer of anti-hepatitis B virus surface antigen antibody

    The 1th year after whole course of hepatitis B vaccination

  • Geometric mean titer of anti-hepatitis B virus surface antigen antibody

    The 2th year after whole course of hepatitis B vaccination

  • Geometric mean titer of anti-hepatitis B virus surface antigen antibody

    The 3th year after whole course of hepatitis B vaccination

Study Arms (1)

10μg/0.5ml recombinant HBV vaccine

EXPERIMENTAL

5000 participants who are healthy neonates receive 10μg/0.5ml recombinant hepatitis B vaccine on day 0, 30 and 60.

Biological: 10μg/0.5ml recombinant hepatitis B vaccine

Interventions

10μg/0.5ml recombinant hepatitis B vaccineBIOLOGICAL

5000 participants who are healthy neonates receive 10μg/0.5ml recombinant hepatitis B vaccine on day 0, 30 and 60.

10μg/0.5ml recombinant HBV vaccine

Eligibility Criteria

AgeUp to 24 Hours
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Subjects who are healthy full-term infants after birth, Apgar score ≥8;
  • Subjects with a birth weight ≥ 2500g;
  • Subjects' guardians are able to understand and sign informed consent;
  • Subjects who can and will comply with the requirements of the protocol.

You may not qualify if:

  • Family history of eclampsia, epilepsy and encephalopathy;
  • Subjects' birth mother had immune system dysfunction, or history of organ transplantation or blood dialysis;
  • Subjects' parents had a medical history of allergic to any ingredient of the vaccine, including supplementary material and formaldehyde;
  • Subjects' parents had a medical history of allergic to combined hepatitis A and B vaccine(HAB) or hepatitis B vaccine;
  • Subjects had serious acute and chronic diseases;
  • with temperature ≧37.1℃;
  • Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gaozhou District Center for Disease Control and Prevention

Maoming, Guangdong, China

RECRUITING

Xinxing District Center for Disease Control and Prevention

Yunfu, Guangdong, China

RECRUITING

MeSH Terms

Conditions

HepatitisHepatitis BLiver DiseasesDigestive System Diseases

Interventions

Hepatitis B Vaccines

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, Human

Intervention Hierarchy (Ancestors)

Viral Hepatitis VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Zheng Huizhen, master

    Guangdong Center for Disease Prevention and Control

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Huang Zhuhang, master

CONTACT

+86-020-36271871jade_lyy@126.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2016

First Posted

May 6, 2016

Study Start

May 1, 2015

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

May 6, 2016

Record last verified: 2016-05

Locations

CN(2)