Immunogenicity, Safety & Reactogenicity of GSK Vaccine Tritanrix™-HepB/Hib2.5 Compared to GSK Vaccine Tritanrix™-HepB/Hiberix™

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Haemophilus Influenzae Type b

Treatments

Biological: Tritanrix™-HepB

Biological: Hib 2.5

Biological: Unconjugated Hib vaccine (plain PRP)

Biological: Hiberix™

Biological: Tritanrix™-HepB low thio /

Study type

Interventional

Funder types

Industry

Identifiers

NCT01061541

208108/092 (Other Identifier)

208108/091

Details and patient eligibility

About

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).

Enrollment

192 patients

Sex

All

Ages

6 to 8 weeks old

Volunteers

Accepts Healthy Volunteers

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.