Safety Study of a Vaccine Against Meningitis in Infants ( 2,4 & 6 Months Age) After a Birth Dose of Hepatitis B.

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Haemophilus Influenzae Type b; Diphtheria; Whole Cell Pertussis; Tetanus; Hepatitis B

Treatments: Biological: Tritanrix/Hiberix vaccine; Biological: Tritanrix-HepB/Meningitec conjugate vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00317135

759346/004

Details and patient eligibility

About

The purpose of this study is to compare the reactogenicity & safety of Tritanrix™-HepB/Hib-MenAC vaccine to the international standard of care, Tritanrix™-HepB/Hiberix™.

Full description

Randomized study with four groups to receive one of the following vaccination regimens after a dose of hepatitis B vaccine given at birth:

• One of the 3 lots of GSK Biologicals' Hib-MenAC mixed with GSK Biologicals' Tritanrix™-HepB (3 different groups) - GSK Biologicals' Tritanrix™-HepB/Hiberix™

Enrollment: 500 patients

Sex: All

Ages: Under 3 days old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria at study entry:

• Healthy infants aged less than or equal to 3 days of age, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks.

Exclusion criteria at study entry:

• Any confirmed immunodeficient condition, based on medical history & physical examination.
• A family history of congenital or hereditary immunodeficiency.
• Major congenital defects or serious chronic illness.
• History of any neurologic disorders or seizures.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
• Acute disease at the time of enrolment.

Trial design

500 participants in 4 patient groups

Hib-MenAC Lot 1 Group

Experimental group

Description:

Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB combined vaccine mixed extemporaneously with Meningitec conjugate vaccine Lot 1 at 2, 4 and 6 months of age as an intramuscular injections in the anterolateral part of the left thigh.

Treatment:

Biological: Tritanrix-HepB/Meningitec conjugate vaccine

Hib-MenAC Lot 2 Group

Experimental group

Description:

Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB combined vaccine mixed extemporaneously with Meningitec conjugate vaccine Lot 2 at 2, 4 and 6 months of age as an intramuscular injections in the anterolateral part of the left thigh.

Treatment:

Biological: Tritanrix-HepB/Meningitec conjugate vaccine

Hib-MenAC Lot 3 Group

Experimental group

Description:

Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB combined vaccine mixed extemporaneously with Meningitec conjugate vaccine Lot 3 at 2, 4 and 6 months of age as an intramuscular injections in the anterolateral part of the left thigh.

Treatment:

Biological: Tritanrix-HepB/Meningitec conjugate vaccine

Hiberix Group

Active Comparator group

Description:

Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB vaccine mixed extemporaneously with conjugate vaccine Hiberix at 2, 4 and 6 months of age as intramuscular injection in the anterolateral part of the thigh.

Treatment:

Biological: Tritanrix/Hiberix vaccine