Clinical trial NCT01061541: Immunogenicity, Safety & Reactogenicity of GSK Vaccine Tritanrix™-HepB/Hib2.5 Compared to GSK Vaccine Tritanrix™-HepB/Hiberix™
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Haemophilus Influenzae Type b
Keywords: Pertussis
Tetanus
Hiberix™
Hepatitis B
DTPw-HBV vaccine
Tritanrix™-HepB
Haemophilus influenzae type b
Diphtheria
Hib vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-02-03
Enrollment: 192
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* 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.
* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: 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:
measure: anti-HBs antibody concentration
timeFrame: One month after the third dose of the primary vaccination course
measure: anti-PRP antibody concentration
timeFrame: One month after the third dose of the primary vaccination course
measure: anti-tetanus antibody concentration
timeFrame: One month after the third dose of the primary vaccination course
measure: anti-diphtheria antibody concentration
timeFrame: One month after the third dose of the primary vaccination course
measure: anti-Bordetella pertussis (BPT) antibody concentration
timeFrame: One month after the third dose of the primary vaccination course
measure: Vaccine response to Bordetella pertussis antigen.
timeFrame: One month after the third dose of the primary vaccination course
measure: Seropositivity/seroprotection rates and GMCs for antibodies against all vaccine antigens
timeFrame: Before the first dose of the primary vaccination course
measure: anti-PRP antibody concentration
timeFrame: Before and one month after the plain PRP challenge dose.
measure: Occurrence of solicited symptoms
timeFrame: During the 4-day follow-up period after each dose
measure: Occurrence of unsolicited symptoms
timeFrame: During the 31-day follow-up period after each dose
measure: Occurrence of serious adverse events
timeFrame: Over the full course of the study
Other outcomes:
Locations:
city: Muntinlupa
country: Philippines
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Gatchalian SR, Ramakrishnan G, Bock HL, Lefevre I, Jacquet JM. 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. 2010 Aug;6(8):664-72. doi: 10.4161/hv.6.8.12155.