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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00317187

100791

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: 56 to 83 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy infants 56-83 days of age at the time of the first vaccine dose, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks & has received a birth dose of hepatitis B vaccine within the first 3 days of life.

Exclusion criteria

• Any confirmed immunodeficient condition, based on medical history and physical examination.
• Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of study vaccine, or planned administration during the study period with the exception of oral polio vaccine (OPV).
• 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 (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
• Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
• Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, and/or meningococcal disease.
• History of diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or meningococcal disease or known exposure to these diseases since birth.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

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