Safety Study of GSK Biologicals' DTPa-IPV/Hib (Infanrix™-IPV/Hib)

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

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

Treatments: Biological: Infanrix™-IPV/Hib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00964028

112065

Details and patient eligibility

About

This study will evaluate the safety and reactogenicity of Infanrix-IPV/Hib given as a three-dose primary vaccination course to healthy infants at 2-3-4 or 3-4-5 months of age.

Enrollment: 50 patients

Sex: All

Ages: 60 to 90 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• A male or female infant between, and including, 60 and 90 days of age at the time of the first study visit.
• Born after a gestation period of 36 to 42 weeks inclusive.
• Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
• 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 other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
• Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with the exception of hepatitis B vaccine.
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
• Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis and/or Hib disease.
• Previous vaccination against diphtheria, tetanus, pertussis, poliovirus and/or Haemophilus influenzae type b diseases.
• History of seizures or progressive neurological disease.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Major congenital defects or serious chronic illness.

The following condition is temporary or self-limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met:

• Current febrile illness or axillary temperature > 37.0 ºC or other moderate to severe illness within 24 hours of study vaccine administration.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

INFANRIX-IPV/HIB M2-M3-M4 GROUP

Experimental group

Description:

Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.

Treatment:

Biological: Infanrix™-IPV/Hib

INFANRIX-IPV/HIB M3-M4-M5 GROUP

Experimental group

Description:

Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.

Treatment:

Biological: Infanrix™-IPV/Hib