Immunogenicity and Safety Study in Infants of GlaxoSmithKline Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib) Vaccine

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

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

Treatments: Biological: Infanrix hexa™

Study type: Interventional

Funder types: Industry

Identifiers

NCT01353703

2013-003427-10 (EudraCT Number)

111157

Details and patient eligibility

About

This study evaluates the immunogenicity and safety of Infanrix hexa™ (DTPa-HBV-IPV/Hib) when administered as a primary vaccination course to Indian infants according to a 6-10-14 weeks or a 2-4-6 months schedule.

Enrollment: 224 patients

Sex: All

Ages: 6 to 10 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

All subjects must satisfy ALL the following criteria at study entry:

• A male or female between, and including, 6 and 10 weeks of age at the time of the first vaccination
• Documented administration of a hepatitis B vaccine dose at birth
• Subjects who the investigator believes that their parent(s)/legally acceptable representative(s) [LAR(s)] can and will comply with the requirements of the protocol
• Written informed consent obtained from the parent(s)/LAR(s) of the subject
• Healthy subjects as established by medical history and clinical examination before entering into the study
• Born after a gestation period of at least 36 weeks

Exclusion criteria

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

• Child in care
• Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose, or planned use during the study period
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose
• Administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, or planned administration during the study period, with the exception of oral human rotavirus (HRV) vaccination which is allowed at any time during the study
• 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 diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b (Hib) vaccination or disease, with the exception of a birth dose of hepatitis B vaccine and oral poliovirus vaccine (OPV) as per local standard of care
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
• Family history of congenital or hereditary immunodeficiency
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine
• Major congenital defects or serious chronic illness
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period
• Acute disease and/or fever at the time of enrolment

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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224 participants in 2 patient groups

INFANRIX HEXA 6-10-14 GROUP

Experimental group

Description:

Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.

Treatment:

Biological: Infanrix hexa™

INFANRIX HEXA 2-4-6 GROUP

Active Comparator group

Description:

Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.

Treatment:

Biological: Infanrix hexa™