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

Study Overview
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Brief Summary
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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.

Official Title
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Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Infanrix Hexa™ Vaccine in Healthy Infants in India

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

Intervention / Treatment
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* Biological: Infanrix hexa™


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Weeks
Maximum Age: 10 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INFANRIX HEXA 6-10-14 GROUP<br>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. | Biological: Infanrix hexa™<br>* Intramuscular, three doses<br>* Other names: DTPa-HBV-IPV/Hib;|
| Active Comparator: INFANRIX HEXA 2-4-6 GROUP<br>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. | Biological: Infanrix hexa™<br>* Intramuscular, three doses<br>* Other names: DTPa-HBV-IPV/Hib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens | 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). | One month post Dose 3 (Month 3 or Month 5) | 
| Number of Seroprotected Subjects Against Hepatitis B (HBs) | A seroprotected subject was defined as a vaccinated subject with anti-HBS antibody concentration ≥ 10 milli-international units per milliliter (mIU/mL). | One month post Dose 3 (Month 3 or Month 5) | 
| Number of Seroprotected Subjects Against Poliovirus (Polio) Types 1,2,3 Antigens | 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). | One month post Dose 3 (Month 3 or Month 5) | 
| Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP) Antigens | A seroprotected subject was defined as a subject with anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL). | One month post Dose 3 (Month 3 or Month 5) | 
| Number of Subjects With Vaccine Response for Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) | 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. | One month post Dose 3 (Month 3 or Month 5) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-D and Anti-T Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). | One month post Dose 3 (Month 3 or Month 5) | 
| Anti-HBs Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL). | One month post Dose 3 (Month 3 or Month 5) | 
| Anti-Polio Types 1, 2, 3 Antibody Titers | Antibody titers were presented as geometric mean titers (GMTs). | One month post Dose 3 (Month 3 or Month 5) | 
| Anti-PRP Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL. | One month post Dose 3 (Month 3 or Month 5) | 
| Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. | One month post Dose 3 (Month 3 or Month 5) | 
| Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL. | One month post Dose 3 (Month 3 or Month 5) | 
| Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens | 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). | At Month 0 | 
| Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL. | At Month 0 | 
| Number of Seroprotected Subjects Against Anti-HBs Antigens | A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. | At Month 0 | 
| Anti-Polio Types 1, 2 and 3 Antibody Titers | Antibody titers were presented as geometric mean titers (GMTs). | At Month 0 | 
| Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. | At Month 0 | 
| Anti-HBs Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL. | At Month 0 | 
| Number of Subjects With Any Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of any particular symptom regardless of intensity grade. | 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) | 
| Number of Subjects With Solicited General Symptoms | 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. | 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) | 
| Number of Subjects With Unsolicited Adverse Events (AEs) | 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. | 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) | 
| Number of Subjects With Serious Adverse Events (SAEs) | 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. | 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)) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infanrix hexa™, Primary vaccination, India, combination vaccine, infants