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

Phase 3

Completed

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

Interventions: Biological: Infanrix hexa™

Registration Number: NCT01353703

Lead Sponsor: GlaxoSmithKline

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 224

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
INFANRIX HEXA 2-4-6 GROUP	Infanrix hexa™	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.
INFANRIX HEXA 6-10-14 GROUP	Infanrix hexa™	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.

Primary Outcome Measures

Name	Time	Method
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens	One month post Dose 3 (Month 3 or Month 5)	A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Number of Seroprotected Subjects Against Hepatitis B (HBs)	One month post Dose 3 (Month 3 or Month 5)	A seroprotected subject was defined as a vaccinated subject with anti-HBS antibody concentration ≥ 10 milli-international units per milliliter (mIU/mL).
Number of Seroprotected Subjects Against Poliovirus (Polio) Types 1,2,3 Antigens	One month post Dose 3 (Month 3 or Month 5)	A seroprotected subject was defined as a subject with anti-Poliovirus 1,2 and 3 antibody titers ≥ 8 effective dose, for 50% of people receiving the vaccine (ED50).
Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP) Antigens	One month post Dose 3 (Month 3 or Month 5)	A seroprotected subject was defined as a subject with anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).
Number of Subjects With Vaccine Response for Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)	One month post Dose 3 (Month 3 or Month 5)	Vaccine response was defined as : For initially seronegative subjects (S-), antibody concentration ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) at 1 month after the third dose; For initially seropositive subjects (S+): antibody concentration at 1 month after the third dose ≥ 1 fold increase in the pre-vaccination antibody concentration.

Secondary Outcome Measures

Name	Time	Method
Anti-D and Anti-T Antibody Concentrations	One month post Dose 3 (Month 3 or Month 5)	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
Anti-HBs Antibody Concentrations	At Month 0	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.
Anti-Polio Types 1, 2, 3 Antibody Titers	One month post Dose 3 (Month 3 or Month 5)	Antibody titers were presented as geometric mean titers (GMTs).
Anti-PRP Antibody Concentrations	One month post Dose 3 (Month 3 or Month 5)	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations	At Month 0	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN	At Month 0	A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens	At Month 0	A seroprotected subject was defined as a subject with anti-Polio type 1, 2 and 3 antibody titers ≥ 8 effective dose, for 50% of people receiving the vaccine (ED50).
Number of Seroprotected Subjects Against Anti-HBs Antigens	At Month 0	A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.
Anti-Polio Types 1, 2 and 3 Antibody Titers	At Month 0	Antibody titers were presented as geometric mean titers (GMTs).
Number of Subjects With Any Solicited Local Symptoms	During the 4-day (Days 0-3) post-vaccination period after each dose and across doses: Up to Month 2 (Infanrix Hexa 6-10-14 Group) or Month 4 (Infanrix Hexa 2-4-6 Group)	Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of any particular symptom regardless of intensity grade.
Number of Subjects With Solicited General Symptoms	During the 4-day (Days 0-3) post-vaccination period after each dose and across doses: Up to Month 2 (Infanrix Hexa 6-10-14 Group) or Month 4 (Infanrix Hexa 2-4-6 Group)	Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite and temperature \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = incidence of any particular symptom regardless of intensity grade or relationship to study vaccination.
Number of Subjects With Unsolicited Adverse Events (AEs)	During the 31-day (Days 0-30) post-vaccination period: Up to Month 3 (Infanrix Hexa 6-10-14 Group) or Month 5 (Infanrix Hexa 2-4-6 Group)	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Number of Subjects With Serious Adverse Events (SAEs)	During the entire study period (from Month 0 up to Month 3 (Infanrix Hexa 6-10-14 Group) or Month 5 (Infanrix Hexa 2-4-6 Group))	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.