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

Immunogenicity and Safety of GSK Biological's DTPa-HBV-IPV/Hib Vaccine or DTPa-IPV/Hib Co-administered With HBV Vaccine as Primary and Booster Vaccination in Healthy Infants Born to Hepatitis B Surface Antigen Negative Mothers

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis B
• Intervention / Treatment: Biological: DTPa-HBV-IPV/Hib vaccine; Biological: DTPa-IPV/Hib vaccine; Biological: EngerixTM-B

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 1 month (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Inclusion criteria for enrolment at birth

• 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.

Inclusion criteria for administration of the combined vaccine regimen

• 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.

Inclusion criteria for administration of the booster dose

• 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:

Exclusion criteria for enrolment at birth

• 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).

Exclusion criteria for administration of the combined vaccine regimen

• 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.

Exclusion criteria for administration of the booster dose

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group A	Biological: 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.
EXPERIMENTAL: Group B	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Seroprotective anti-HBs antibody titres above protocol specified cut-off value	At the time of the second dose of combined vaccination, one month after the 3rd dose of combined vaccination and one month after the booster dose.

Secondary Outcome Measures

Outcome Measure	Time Frame
Antibody titres against all investigational vaccine antigen components	One month after first combined vaccine dose, two months after Dose 1, one month after third combined vaccine dose prior to booster vaccination and one month post-booster vaccination.
Occurrence of solicited symptoms	During the 4-day follow-up period after each dose
Occurrence of unsolicited symptoms	During the 30-day follow-up period after each dose of study vaccine
Occurrence of Serious Adverse Events	From the birth dose of hepatitis B vaccine and ending with the last study visit or performance of the last study procedure or a minimum of 30 days following the third dose of the mixed vaccines and from the start of booster dose and ending a minimum of 3

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• 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.

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start: January 1, 2001
• Primary Completion (ACTUAL): November 1, 2002
• Study Completion (ACTUAL): November 1, 2002

Study Registration Dates

• First Submitted: April 9, 2009
• First Submitted That Met QC Criteria: April 9, 2009
• First Posted (ESTIMATE): April 13, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): September 7, 2016
• Last Update Submitted That Met QC Criteria: September 6, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis B; Hepatitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Immunologic Factors; Protective Agents; Anticoagulants; Antidotes; Chelating Agents; Sequestering Agents; Iron Chelating Agents; Calcium Chelating Agents; Vaccines; Edetic Acid; Pentetic Acid
• Other Study ID Numbers: 217744/069

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Informed Consent Form
   Information identifier: 217744/069
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Individual Participant Data Set
   Information identifier: 217744/069
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Dataset Specification
   Information identifier: 217744/069
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Clinical Study Report
   Information identifier: 217744/069
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Study Protocol
   Information identifier: 217744/069
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register