Immune Memory of DTPw-HBV/Hib Vaccine Following Primary Vaccination, Immuno & Reacto of a Booster Dose Given in Infants

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

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

Treatments: Biological: Polyribosil-Ribitol-Phosphate (PRP) vaccine; Biological: Tritanrix™-HepB Kft; Biological: Tritanrix™-HepB/Hiberix™; Biological: Tritanrix™-HepB/Hiberix™ Kft.; Biological: Hiberix™

Study type: Interventional

Funder types: Industry

Identifiers

NCT00169442

104065

Details and patient eligibility

About

To assess the immune memory following primary vaccination of DTPw-HBV/Hib vaccine and to assess immunogenicity and reactogenicity of a booster dose given at 15 - 18 months of age.

Full description

Subjects who received DTPw-HBV/Hib in the primary vaccination without HBV at birth will be randomised (1:3 ratio) to receive either: Plain PRP at 10 months of age followed by DTPw-HBV at 15-18 months of age or DTPw-HBV/Hib at 15-18 months of age. Subjects who received DTPw-HBV + Hib in the primary vaccination without HBV at birth will receive DTPw-HBV + Hib as a booster. Subjects who received DTPw-HBV/Hib in the primary vaccination with HBV at birth will receive DTPw-HBV/Hib vaccine as a booster.

Enrollment: 745 patients

Sex: All

Ages: 10 to 18 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

For subjects receiving Plain PRP followed by DTPw-HBV:

Male or female infant, 10 to 11 months of age, who previously completed the three-dose primary vaccination course with the DTPw-HBV/Hib vaccine.

For subjects receiving DTPw-HBV/Hib or DTPw-HBV + Hib:

Male or female infant, 15-18 months of age, who previously completed the three-dose primary vaccination course with the DTPw-HBV/Hib vaccine.

For all subjects:

• Subjects who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol.
• Free of obvious health problems as established by medical history and clinical examination

Exclusion criteria

• Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding administration of the study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to administration of the study vaccine.
• Planned administration/administration of a vaccine not foreseen by the study protocol starting 30 days before and ending 30 days after administration of the study vaccine with the exception of oral polio vaccine.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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745 participants in 6 patient groups

Tritanrix-HepB/Hiberix Kft. Mix Group

Experimental group

Description:

Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.

Treatment:

Biological: Tritanrix™-HepB/Hiberix™ Kft.

Tritanrix-HepB/Hiberix Kft. Ref Group

Experimental group

Description:

Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.

Treatment:

Biological: Tritanrix™-HepB/Hiberix™ Kft.

Biological: Tritanrix™-HepB/Hiberix™

HB Tritanrix-HepB/Hiberix Kft. Mix Group

Experimental group

Description:

Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.

Treatment:

Biological: Tritanrix™-HepB/Hiberix™ Kft.

Tritanrix-HepB Kft.+Hiberix Group

Experimental group

Description:

Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.

Treatment:

Biological: Hiberix™

Biological: Tritanrix™-HepB Kft

PRP Tritanrix-HepB Kft. Mix Group

Experimental group

Description:

Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received plain Polyribosil-Ribitol-Phosphate (PRP) polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.

Treatment:

Biological: Tritanrix™-HepB/Hiberix™ Kft.

Biological: Tritanrix™-HepB Kft

Biological: Polyribosil-Ribitol-Phosphate (PRP) vaccine

PRP Tritanrix-HepB Kft. Ref Group

Experimental group

Description:

Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received plain Polyribosil-Ribitol-Phosphate (PRP) polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.

Treatment:

Biological: Tritanrix™-HepB/Hiberix™

Biological: Tritanrix™-HepB Kft

Biological: Polyribosil-Ribitol-Phosphate (PRP) vaccine