Immunogenicity and Safety Study of GSK Biologicals' Infanrix-IPV+Hib™ Vaccine

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the immunogenicity and reactogenicity of Infanrix-IPV/Hib™ vaccine when administered to healthy Chinese infants at 2, 3 and 4 or 3, 4 and 5 months of age.

Official Title
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Immunogenicity and Safety of GlaxoSmithKline Biologicals' DTPa-IPV/Hib (Infanrix-IPV+Hib™) in Infants

Conditions
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Tetanus, Poliomyelitis, Acellular Pertussis, Diphtheria, Haemophilus Influenzae Type b

Intervention / Treatment
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* Biological: Infanrix-IPV/Hib™
* Biological: Infanrix Hib™
* Biological: Poliorix™


Participation Criteria
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Eligibility Criteria
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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 parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol. Written informed consent obtained from the parent(s) or LAR(s) 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(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. Child in care. 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 Haemophilus influenzae type b (Hib) disease or vaccination. History of seizures or progressive neurological disease. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s). 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°C or other moderate to severe illness within 24 hours of study vaccine administration.

Ages Eligible for Study
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Minimum Age: 60 Days
Maximum Age: 90 Days

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-IPV+HIB 1 GROUP<br>Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh. | Biological: Infanrix-IPV/Hib™<br>* Intramuscular, three doses<br>|
| Experimental: INFANRIX-IPV+HIB 2 GROUP<br>Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh. | Biological: Infanrix-IPV/Hib™<br>* Intramuscular, three doses<br>|
| Active Comparator: INFANRIX-HIB+POLIORIX GROUP<br>Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively. | Biological: Infanrix Hib™<br>* Intramuscular, three doses<br>Biological: Poliorix™<br>* Intramuscular, three doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens | A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). | One month after the third vaccine dose (Month 3 or Month 4) | 
| Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigen | A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (μg/mL). | One month after the third vaccine dose (Month 3 or Month 4) | 
| Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens | A seroprotected subject was defined as a subject with anti-poliovirus (anti-polio) types 1, 2 and 3 antibody titres ≥ the value of 8. | One month after the third vaccine dose (Month 3 or Month 4) | 
| Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens | Vaccine response was defined as: For PT and FHA response, antibody concentration ≥ 20 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) at post-vaccination. For PRN response: for initially seronegative subjects [antibody concentration lower than (<) 5 EL.U/mL], post-vaccination antibody concentration ≥ 20 EL.U/mL; for initially seropositive subjects (antibody concentration ≥ 5 EL.U/mL), at least a 4-fold increase in antibody concentration from pre to post-vaccination. | One month after the third vaccine dose (Month 3 or Month 4) | 

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 IU/mL. | Before the first dose (Month 0) and one month after the third dose of vaccination (Month 3 or Month 4) | 
| Anti-PRP Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL. | Before the first dose (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4) | 
| Anti-polio Types 1, 2 and 3 Antibody Titers | Antibody titers were presented as geometric mean titers (GMTs). | Before the first dose (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4) | 
| Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. | Before (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4) | 
| Number of Subjects With Any Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. | During the 4-day (Days 0-3) post-vaccination period after each vaccine dose and across doses | 
| Number of Subjects With Any Solicited General Symptoms | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to study vaccination. | During the 4-day (Days 0-3) post-vaccination period after each vaccine dose and across doses | 
| 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 after any dose | 
| 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 to Month 4/5) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infanrix-IPV+Hib