Immunogenicity and Safety of Primary and Booster Vaccination With DTPa-HBV-IPV/Hib Vaccine

NCT ID: NCT00880477

Last Updated: 2016-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-01-31
• Study Completion Date: 2002-11-30

Brief Summary

This study will assess the immunogenicity, safety and reactogenicity of GSK Biological's DTPa-HBV-IPV/ Hib vaccine as compared to GSK's DTPa-IPV/Hib vaccine co-administered with HBV according to a three-dose immunisation course and as a booster dose in infants born to hepatitis B antigen seronegative mothers and previously primed with a birth dose of GSK's HBV vaccine.

Conditions

Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group A

Group Type: EXPERIMENTAL

DTPa-HBV-IPV/Hib vaccine

Intervention Type: BIOLOGICAL

Vaccination according to a 3-dose schedule at 1 ½, 3 ½ and 6 months of age with booster at 15-18 months of age.

Group B

Group Type: EXPERIMENTAL

DTPa-IPV/Hib vaccine

Intervention Type: BIOLOGICAL

Vaccination according to a 3-dose schedule at at 1 ½, 3 ½ and 6 months of age with booster at 15-18 months of age.

EngerixTM-B

Intervention Type: BIOLOGICAL

The vaccine was administered according to a 2-dose schedule at 1½ and 6 months of age with booster at 15-18 months of age.

Interventions

DTPa-HBV-IPV/Hib vaccine

Vaccination according to a 3-dose schedule at 1 ½, 3 ½ and 6 months of age with booster at 15-18 months of age.

Intervention Type: BIOLOGICAL

DTPa-IPV/Hib vaccine

Vaccination according to a 3-dose schedule at at 1 ½, 3 ½ and 6 months of age with booster at 15-18 months of age.

Intervention Type: BIOLOGICAL

EngerixTM-B

The vaccine was administered according to a 2-dose schedule at 1½ and 6 months of age with booster at 15-18 months of age.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Written informed consent obtained from the parents or guardians of the subject.
• A male or female infant born after a normal gestation period (between 36 and 42 weeks).
• Born to a mother seronegative for HBsAg.
• Free of obvious health problems as established by clinical examination before entering into the study.

• Between, and including, 6 and 8 weeks of age at the time of the first dose of the three-dose course of vaccination.
• Free of obvious health problems as established by medical history and clinical examination before entering into this phase of the study.

• Between, and including, 15 and 18 months of age at the time of the booster vaccination.
• Written informed consent obtained from the parents or guardians of the subject.
• Free of obvious health problems as established by medical history and clinical examination before entering into the study.
• Completion of the three-dose primary vaccination course.

Exclusion Criteria

• A family history of congenital or hereditary immunodeficiency.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
• Major congenital defect(s).

• Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration Immunosuppressants or other immune-modifying drugs since birth.
• Any chronic drug therapy to be continued during the study period.
• Planned administration/ administration of a vaccine except Bacille Calmette-Guérin vaccine during the period starting from 30 days before each dose of vaccines and ending 30 days after.
• Previous vaccination against diphtheria, tetanus, pertussis or Haemophilus influenzae type b disease.
• History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B and/or Haemophilus influenzae type b disease.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Serious chronic illness.
• History of any neurologic disorders or seizures.
• Acute disease at the time of enrolment.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

• Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the booster dose of study vaccines, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months of vaccination.
• Previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and/or Haemophilus influenzae type b.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Acute disease at the time of enrolment.
• History of any neurologic disorders or seizures.
• Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose of study vaccine or planned administration during the study period.
• Hypersensitivity reaction due to vaccine in primary course
• Encephalopathy within 7 days of previous vaccination with DTP vaccine

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 8 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

References

Shao PL, Lu CY, Hsieh YC, Bock HL, Huang LM; Taiwan Infanrix-069 Study Group. Immunogenicity and reactogenicity of DTPa-IPV/Hib vaccine co-administered with hepatitis B vaccine for primary and booster vaccination of Taiwanese infants. J Formos Med Assoc. 2011 Jun;110(6):415-22. doi: 10.1016/S0929-6646(11)60061-2.

Reference Type: BACKGROUND

PMID: 21741011 (View on PubMed)

Study Documents

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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Other Identifiers

217744/069

Identifier Type: -

Identifier Source: org_study_id