Last updated: 11/04/2018 01:08:55
Immunogenicity and safety of primary and booster vaccination with DTPa-HBV-IPV/Hib vaccine
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Seroprotective anti-HBs antibody titres above protocol specified cut-off value
Timeframe: 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 outcomes:
Antibody titres against all investigational vaccine antigen components
Timeframe: 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
Timeframe: During the 4-day follow-up period after each dose
Occurrence of unsolicited symptoms
Timeframe: During the 30-day follow-up period after each dose of study vaccine
Occurrence of Serious Adverse Events
Timeframe: 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
Interventions:
Enrollment:
140
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Shao PL et al. (2011) 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.110(6):415-422.
Medical condition
Hepatitis B
Product
Hepatitis B Vaccine, Recombinant
Collaborators
Not applicable
Study date(s)
January 2001 to November 2002
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
6 - 8 weeks
Accepts healthy volunteers
Yes
- Inclusion criteria for enrolment at birth
- Written informed consent obtained from the parents or guardians of the subject.
- Exclusion criteria for enrolment at birth
- A family history of congenital or hereditary immunodeficiency.
Inclusion and exclusion criteria
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
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2002-30-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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