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

Phase 3

Completed

Conditions: Tetanus
Acellular Pertussis
Haemophilus Influenzae Type b
Diphtheria
Poliomyelitis

Interventions: Biological: Infanrix-IPV/Hib™
Biological: Infanrix Hib™
Biological: Poliorix™

Registration Number: NCT01086423

Lead Sponsor: GlaxoSmithKline

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 985

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
INFANRIX-IPV+HIB 1 GROUP	Infanrix-IPV/Hib™	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.
INFANRIX-HIB+POLIORIX GROUP	Infanrix Hib™	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.
INFANRIX-HIB+POLIORIX GROUP	Poliorix™	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.
INFANRIX-IPV+HIB 2 GROUP	Infanrix-IPV/Hib™	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.

Primary Outcome Measures

Name	Time	Method
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigen	One month after the third vaccine dose (Month 3 or Month 4)	A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (μg/mL).
Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens	One month after the third vaccine dose (Month 3 or Month 4)	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.
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens	One month after the third vaccine dose (Month 3 or Month 4)	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).
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens	One month after the third vaccine dose (Month 3 or Month 4)	A seroprotected subject was defined as a subject with anti-poliovirus (anti-polio) types 1, 2 and 3 antibody titres ≥ the value of 8.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects With Any Solicited General Symptoms	During the 4-day (Days 0-3) post-vaccination period after each vaccine dose and across doses	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.
Number of Subjects With Any Solicited Local Symptoms	During the 4-day (Days 0-3) post-vaccination period after each vaccine dose and across doses	Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Anti-D and Anti-T Antibody Concentrations	Before the first dose (Month 0) and one month after the third dose of vaccination (Month 3 or Month 4)	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.
Anti-PRP Antibody Concentrations	Before the first dose (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4)	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.
Anti-polio Types 1, 2 and 3 Antibody Titers	Before the first dose (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4)	Antibody titers were presented as geometric mean titers (GMTs).
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations	Before (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4)	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Number of Subjects With Unsolicited Adverse Events (AEs)	During the 31-day (Days 0-30) post-vaccination period after any dose	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 to Month 4/5)	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.