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

GlaxoSmithKline985 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

985

Conditions

Tetanus Poliomyelitis Acellular Pertussis Diphtheria Haemophilus Influenzae Type b

Interventions

Infanrix-IPV/Hib™BIOLOGICAL

Intramuscular, three doses

Infanrix Hib™BIOLOGICAL

Intramuscular, three doses

Poliorix™BIOLOGICAL

Intramuscular, three doses

Eligibility

Sex: ALLMin age: 60 DaysMax age: 90 DaysHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

GSK Investigational Site

Wuzhou, Guangxi, China

GSK Investigational Site

Wuzhou, Guangxi, China

Outcomes

Primary Outcomes

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).

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: One month after the third vaccine dose (Month 3 or Month 4)

Secondary Outcomes

Anti-D and Anti-T Antibody Concentrations

Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.

Data from ClinicalTrials.gov

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