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

Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00880477
• Other study ID #: 217744/069
• Status: Completed
• Phase: Phase 3
• First received: April 9, 2009
• Last updated: September 6, 2016
• Start date: January 2001
• Est. completion date: November 2002

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: November 2002
• Est. primary completion date: November 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Weeks to 8 Weeks

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No
Secondary	Occurrence of solicited symptoms		During the 4-day follow-up period after each dose	No
Secondary	Occurrence of unsolicited symptoms		During the 30-day follow-up period after each dose of study vaccine	No
Secondary	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	No

External 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.