Immunogenicity and Reactogenicity of a Booster Dose of GSK Bio's DTPa-HBV-IPV/Hib Vaccine

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Poliomyelitis; Haemophilus Influenzae Type b; Diphtheria; Hepatitis B; Tetanus; Acellular Pertussis

Treatments: Biological: Infanrix Hexa

Study type: Interventional

Funder types: Industry

Identifiers

NCT00627458

111344

Details and patient eligibility

About

The purpose of this booster study is to evaluate, in subjects primed in the primary study 106786, the persistence, at the time of the booster vaccination, of antibodies elicited by the different formulation of DTPa-HBV-IPV/ Hib vaccine (Infanrix Hexa TM). The study will also evaluate the immune response of these subjects to a DTPa-HBV-IPV/Hib booster. This protocol posting deals with the objectives and outcome measures of the booster phase. The objectives and outcomes measures of the primary phase are presented in a separate protocol posting (NCT = 00376779).

Full description

This protocol posting has been updated in order to comply with the FDA AA, Sep 2007.

Enrollment: 403 patients

Sex: All

Ages: 16 to 20 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
• Subjects must have completed the full three-dose primary vaccination course with one of the formulations of the DTPa-HBV-IPV/Hib vaccine in primary study 106786.
• A male or female between, and including, 16 and 20 months of age at the time of booster vaccination.
• Written informed consent obtained from the parent or guardian of the subject
• Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion criteria

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose.
• Participation in another clinical study, between the primary study 106786 and the present booster study, or at any time during the study, in which the subject has been or will be exposed to an investigational or a non-investigational product.
• Planned administration or administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the booster dose and ending 30 days after the booster dose.
• Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib booster vaccination or disease since the conclusion visit of study 106786.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
• Acute disease at the time of enrolment.
• Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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403 participants in 3 patient groups

INFANRIX HEXA PF GROUP

Experimental group

Description:

Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.

Treatment:

Biological: Infanrix Hexa

INFANRIX HEXA PC GROUP

Experimental group

Description:

Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.

Treatment:

Biological: Infanrix Hexa

CONTROL GROUP

Active Comparator group

Description:

Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.

Treatment:

Biological: Infanrix Hexa