Last updated: 11/07/2018 12:49:50
Immunogenicity, safety & reactogenicity of GSK vaccine Tritanrix™-HepB/Hib2.5 compared to GSK vaccine Tritanrix™-HepB/Hiberix™
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A phase II, double-blind, randomized study to compare the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ Tritanrix™-HepB/Hib2.5 to GSK Biologicals’ Tritanrix™-HepB/Hiberix™ when administered as a three-dose primary vaccination course to healthy infants at 6, 10 and 14 weeks of age. A dose of unconjugated Hib vaccine (plain PRP booster) will be administered at the age of 10 months to 50% of the subjects
Trial description: In order to reduce the amount of thiomersal in its vaccines, GSK Biologicals has developed a DTPw-HBV vaccine with low thiomersal content (Tritanrix™- HepB low thio). This vaccine is to be used in combination with a Hib low dose vaccine containing 2.5µg of PRP antigen (Hib 2.5). The purpose of this study is to generate clinical data with Tritanrix™-HepB low thio vaccine when extemporaneously mixed with Hib 2.5 vaccine. The control group will receive Tritanrix™-HepB/Hiberix™.Subjects received primary vaccination in study 208108/091 (double blind). Of these subjects 50% were randomised to participate in the PRP challenge study (208108/092) (open), and all subjects will be invited to participate in a booster study DTPWHBV=HIB2.5-093 (101477).
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
anti-PRP antibody concentration above a protocol defined cut-off value.
Timeframe: One month after the third dose of the primary vaccination course.
Secondary outcomes:
anti-HBs antibody concentration
Timeframe: One month after the third dose of the primary vaccination course
anti-PRP antibody concentration
Timeframe: One month after the third dose of the primary vaccination course
anti-tetanus antibody concentration
Timeframe: One month after the third dose of the primary vaccination course
anti-diphtheria antibody concentration
Timeframe: One month after the third dose of the primary vaccination course
anti-Bordetella pertussis (BPT) antibody concentration
Timeframe: One month after the third dose of the primary vaccination course
Vaccine response to Bordetella pertussis antigen.
Timeframe: One month after the third dose of the primary vaccination course
Seropositivity/seroprotection rates and GMCs for antibodies against all vaccine antigens
Timeframe: Before the first dose of the primary vaccination course
anti-PRP antibody concentration
Timeframe: Before and one month after the plain PRP challenge dose.
Occurrence of solicited symptoms
Timeframe: During the 4-day follow-up period after each dose
Occurrence of unsolicited symptoms
Timeframe: During the 31-day follow-up period after each dose
Occurrence of serious adverse events
Timeframe: Over the full course of the study
Interventions:
Biological/vaccine: Tritanrix™-HepB low thio /
Biological/vaccine: Hib 2.5
Biological/vaccine: Tritanrix™-HepB
Biological/vaccine: Hiberix™
Biological/vaccine: Unconjugated Hib vaccine (plain PRP)
Enrollment:
192
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Gatchalian SR et al. (2010) Immunogenicity, reactogenicity and safety of three-dose primary and booster vaccination with combined diphtheria-tetanus-whole-cell pertussis-hepatitis B-reduced antigen content Haemophilus influenzae type b vaccine in Filipino children. Hum Vaccin. 6(8):664-672.
Medical condition
Haemophilus influenzae type b
Product
SB208108
Collaborators
Not applicable
Study date(s)
August 2003 to January 2004
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
6 - 8 weeks
Accepts healthy volunteers
Yes
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female between, and including, 6 and 8 weeks of age at the time of the first vaccination.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before each dose of vaccine, with the exception of oral polio vaccine (OPV).
- Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
Inclusion and exclusion criteria
Inclusion criteria:
- A male or female between, and including, 6 and 8 weeks of age at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Born after a gestation period of 36 to 42 weeks.
- Born to a mother proven seronegative for HBsAg.
Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
Exclusion criteria:
- Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B and/or Hib.
- History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B and/or Hib disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at the time of enrolment.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or history.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before each dose of vaccine, with the exception of oral polio vaccine (OPV).
Trial location(s)
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
Completed
Actual primary completion date
Not applicable
Actual study completion date
2004-14-01
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.
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