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Immunogenicity and Safety of the Hepatitis B Vaccine Hepavax-Gene TF and a Comparator Hepatitis B Vaccine in Newborns

Primary Purpose

Hepatitis B

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

HepavaxGene (thiomersal free)

Engerix B

About this trial

This is an interventional prevention trial for Hepatitis B focused on measuring Hepatitis B Vaccine, Hepatitis B Virus, Antigen, Antibody, Vaccination

Eligibility Criteria

undefined - 1 Day (Child)All SexesAccepts Healthy Volunteers

Three types of subject:

Neonates whose mothers are positive for both HBsAg and HBeAg

Neonates whose mothers are positive for only HBsAg

Neonates whose mothers are negative for both HBsAg and HBeAg

INCLUSION CRITERIA:

Full-term neonates with gestational age from 37 weeks to 42 weeks;
Apgar scores are no less than 7 at birth;
Neonates with standard body temperature (auxiliary temperature < 37.1°);
Neonates weighing ≥ 2,500 grams at birth;
Neonates with icteric index within the normal range (physiologic jaundice is permitted);
Informed consent form signed by parent/guardian;
The requirements of the clinical trial protocol can be observed on the basis of the opinion of the investigator.

EXCLUSION CRITERIA:

Subject's parent has a history of family diseases such as convulsion and brain diseases;
Mothers have low immunologic function or a history of organ transplantation or hemodialysis;
Subject's parent is allergic to any composition of Hepatitis B vaccine;
A family history of thrombocytopenia, or other disturbance of blood coagulation, which may result in a contraindication for intramuscular injection;
Known immunologic function damage;
Mothers had received gamma globulin or immunoglobulin injection during pregnancy;
Any congenital malformation
Known or suspected to suffer from diseases such as active infection and cardiovascular disease;
Any condition believed by the investigator to have possible impact on trial evaluation.

Sites / Locations

Center for Disease Control and Prevention Jiangsu Province

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

HepavaxGene Stratum 1a

Comparator vaccine Stratum 1a

HepavaxGene Stratum 1b

Comparator vaccine Stratum 1b

HepavaxGene Stratum 2

Comparator vaccine Stratum 2

Arm Description

Subjects of mothers with chronic hepatitis B (positive for both HBsAg and hepatitis B envelope antigen - HBeAg)

Subjects of mothers with chronic hepatitis B (positive for both HBsAg and HBeAg)

Subjects of mothers with chronic hepatitis B (positive for HBsAg only)

Subjects of mothers without chronic hepatitis B (negative for both HBsAg and HBeAg)

Outcomes

Primary Outcome Measures

Seroconversion rate for subjects in Stratum 2

Hepatitis B surface antibody (HBsAb) concentrations are measured from blood samples by standard enzyme linked immuno sorbent assay (ELISA) for subjects whose mothers are negative for chronic hepatitis B. Seroconversion rate is defined as HBsAb ≥10 mIU/mL.

Positivity for HBsAg for subjects in Stratum 1

The presence of hepatitis B surface antigen (HBsAg), as determined by ELISA, for subjects whose mothers are positive for chronic hepatitis B

Secondary Outcome Measures

Seroconversion rate for subjects in Stratum 1

Seroconversion rate is defined as HBsAb concentrations from ELISA ≥10 mIU/mL

Solicited adverse events

Local adverse events: pain, erythema, swelling at the injection site Systemic adverse events: irritability, sleepiness, change in eating/breast feeding habits, crying, fever [body temperature ≥38°C]

Seroconversion rate for subjects in Stratum 1

Seroconversion rate is defined as HBsAb concentrations from ELISA ≥10 mIU/mL

Positivity for HBsAg for subjects in Stratum 2

Full Information

NCT ID

NCT01349283

First Posted

May 5, 2011

Last Updated

March 3, 2014

Sponsor

Crucell Holland BV

1. Study Identification

Unique Protocol Identification Number

NCT01349283

Brief Title

Immunogenicity and Safety of the Hepatitis B Vaccine Hepavax-Gene TF and a Comparator Hepatitis B Vaccine in Newborns

Official Title

A Prospective, Randomized, Double-blind, Parallel-group, Controlled Study of the Immunogenicity and Safety of the Recombinant Hepatitis B Vaccine (Hepavax-Gene TF) and a Comparator Univalent Hepatitis B Vaccine in Neonates

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

November 2012 (Actual)

Study Completion Date

November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Crucell Holland BV

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The primary purpose of this study is to determine whether HepavaxGene TF is non-inferior to the comparator vaccine both at impeding hepatitis B transmission from mothers positive for chronic hepatitis B (Stratum 1) to their children and also in terms of seroconversion rate in children of mothers negative for chronic hepatitis B (Stratum 2) one month after completion of the immunization schedule.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis B

Keywords

Hepatitis B Vaccine, Hepatitis B Virus, Antigen, Antibody, Vaccination

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1738 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HepavaxGene Stratum 1a

Arm Type

Experimental

Arm Description

Subjects of mothers with chronic hepatitis B (positive for both HBsAg and hepatitis B envelope antigen - HBeAg)

Arm Title

Comparator vaccine Stratum 1a

Arm Type

Active Comparator

Arm Description

Subjects of mothers with chronic hepatitis B (positive for both HBsAg and HBeAg)

Arm Title

HepavaxGene Stratum 1b

Arm Type

Experimental

Arm Description

Subjects of mothers with chronic hepatitis B (positive for HBsAg only)

Arm Title

Comparator vaccine Stratum 1b

Arm Type

Active Comparator

Arm Description

Subjects of mothers with chronic hepatitis B (positive for HBsAg only)

Arm Title

HepavaxGene Stratum 2

Arm Type

Experimental

Arm Description

Subjects of mothers without chronic hepatitis B (negative for both HBsAg and HBeAg)

Arm Title

Comparator vaccine Stratum 2

Arm Type

Active Comparator

Arm Description

Subjects of mothers without chronic hepatitis B (negative for both HBsAg and HBeAg)

Intervention Type

Biological

Intervention Name(s)

HepavaxGene (thiomersal free)

Intervention Description

10 µg/0.5 mL, intramuscular injection on Day 1, Month 1, Month 6

Intervention Type

Biological

Intervention Name(s)

Engerix B

Intervention Description

10 µg/0.5 mL, intramuscular injection on Day 1, Month 1, Month 6

Primary Outcome Measure Information:

Title

Seroconversion rate for subjects in Stratum 2

Description

Time Frame

Month 7

Title

Positivity for HBsAg for subjects in Stratum 1

Description

The presence of hepatitis B surface antigen (HBsAg), as determined by ELISA, for subjects whose mothers are positive for chronic hepatitis B

Time Frame

Month 2, Month 7 and Month 12

Secondary Outcome Measure Information:

Title

Seroconversion rate for subjects in Stratum 1

Description

Seroconversion rate is defined as HBsAb concentrations from ELISA ≥10 mIU/mL

Time Frame

Month 7

Title

Solicited adverse events

Description

Time Frame

Days 1 to 4

Title

Seroconversion rate for subjects in Stratum 1

Description

Seroconversion rate is defined as HBsAb concentrations from ELISA ≥10 mIU/mL

Time Frame

Month 12

Title

Positivity for HBsAg for subjects in Stratum 2

Time Frame

Months 2, 7 and 12

10. Eligibility

Sex

All

Maximum Age & Unit of Time

1 Day

Accepts Healthy Volunteers

Eligibility Criteria

Three types of subject: Neonates whose mothers are positive for both HBsAg and HBeAg Neonates whose mothers are positive for only HBsAg Neonates whose mothers are negative for both HBsAg and HBeAg INCLUSION CRITERIA: Full-term neonates with gestational age from 37 weeks to 42 weeks; Apgar scores are no less than 7 at birth; Neonates with standard body temperature (auxiliary temperature < 37.1°); Neonates weighing ≥ 2,500 grams at birth; Neonates with icteric index within the normal range (physiologic jaundice is permitted); Informed consent form signed by parent/guardian; The requirements of the clinical trial protocol can be observed on the basis of the opinion of the investigator. EXCLUSION CRITERIA: Subject's parent has a history of family diseases such as convulsion and brain diseases; Mothers have low immunologic function or a history of organ transplantation or hemodialysis; Subject's parent is allergic to any composition of Hepatitis B vaccine; A family history of thrombocytopenia, or other disturbance of blood coagulation, which may result in a contraindication for intramuscular injection; Known immunologic function damage; Mothers had received gamma globulin or immunoglobulin injection during pregnancy; Any congenital malformation Known or suspected to suffer from diseases such as active infection and cardiovascular disease; Any condition believed by the investigator to have possible impact on trial evaluation.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhu Fencai, MD

Organizational Affiliation

Jiangsu Provincial Center for Disease Prevention and Control, China

Official's Role

Principal Investigator

Facility Information:

Facility Name

Center for Disease Control and Prevention Jiangsu Province

City

Nanjing

State/Province

Jiangsu

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

27753794

Citation

Zhu F, Deckx H, Roten R, Michiels B, Sarnecki M. Comparative Efficacy, Safety and Immunogenicity of Hepavax-Gene TF and Engerix-B Recombinant Hepatitis B Vaccines in Neonates in China. Pediatr Infect Dis J. 2017 Jan;36(1):94-101. doi: 10.1097/INF.0000000000001361.

Results Reference

derived

Learn more about this trial

Immunogenicity and Safety of the Hepatitis B Vaccine Hepavax-Gene TF and a Comparator Hepatitis B Vaccine in Newborns

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