Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib, Compared to DTPa-HBV-IPV and Hib Administered Separately

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Poliomyelitis; Diphtheria; Haemophilus Influenzae Type b (Hib); Tetanus; Pertussis; Hepatitis B

Treatments: Biological: DTPa-HBV-IPV (Infanrix penta™); Biological: Hib (Hiberix™); Biological: DTPa-HBV-IPV/Hib (Infanrix hexa™)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01457508

217744/054

Details and patient eligibility

About

This study will assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals' (formerly SB Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared with separate administration of DTPa-HBV-IPV (Infanrix penta™) and Hib (Hiberix™) vaccine administered at 3, 5 and 11 (or 12) months of age.

Enrollment: 440 patients

Sex: All

Ages: 12 to 16 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• A male or female 3 months of age at the time of the first vaccination.
• Free of obvious health problems as established by medical history and clinical examination before entering into the study.
• Written informed consent obtained from the parents or guardians of the subject after they have been advised of the risks and benefits of the study in a language which they clearly understood, and before performance of any study procedure.

Exclusion criteria

The following criteria should be checked at the time of study entry. If any apply at the time of study entry, the subject must not be included in the study:

• 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.
• Administration of chronic immunosuppressants or other immune-modifying drugs within three months before vaccination.
• Administration of a vaccine not foreseen by the study within 30 days before each dose of the study vaccines and ending 30 days after.
• Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease.
• History of /or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease or infection.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including allergic reactions to neomycin and polymyxin B.
• Major congenital defects or serious chronic illness.
• History of seizures or of any neurological disease at study entry.
• Administration of immunoglobulins and/or any blood products since birth, or planned administration during the study period.
• Acute disease at time of enrolment

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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440 participants in 2 patient groups

Group A

Experimental group

Description:

Subjects will receive one single injection of DTPa-HBV-IPV vaccine mixed with Hib vaccine.

Treatment:

Biological: DTPa-HBV-IPV/Hib (Infanrix hexa™)

Group B

Active Comparator group

Description:

Subjects will receive two separate injections of DTPa-HBV-IPV and Hib vaccine.

Treatment:

Biological: DTPa-HBV-IPV (Infanrix penta™)

Biological: Hib (Hiberix™)