Study to Assess Safety & Immunogenicity of GSK Biologicals' DTPa/Hib Vaccine vs Separate Administration of DTPa and Hib.

GlaxoSmithKline660 enrolled

Overview

This study will compare GSK Biologicals' DTPa/Hib vaccine to separately administered DTPa and Hib vaccines in Chinese infants 3, 4 \& 5 months of age, in terms of safety and immunogenicity.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

660

Conditions

Tetanus Diphtheria Acellular Pertussis

Interventions

Infanrix™/HibBIOLOGICAL

InfanrixBIOLOGICAL

HiberixBIOLOGICAL

Eligibility

Sex: ALLMin age: 90 DaysMax age: 120 DaysHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * A male or female between, and including, 90 and 120 days of age at the time of the first vaccination, * written informed consent obtained from the parent or guardian of the subject Exclusion Criteria: * Subjects with known exposure to diphtheria, tetanus, pertussis and/or Haemophilus influenzae disease can not participate, * Subjects who have received previous vaccination against diphtheria, tetanus, acellular pertussis and/or Haemophilus influenzae type b diseases can not participate.

Locations (2)

GSK Investigational Site

Mengshan, China

GSK Investigational Site

Wuzhou, China

Outcomes

Primary Outcomes

Number of Seroprotected Subjects Against Diphteria Toxoid (D) and Tetanus Toxoid (T)

A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations higher than or equal to (≥) 0.1 international units per milliliter (IU/mL).

Time frame: At Month 3

Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP)

A seroprotected subject was defined as a vaccinated subject with an anti-PRP antibody concentration higher than or equal to (≥) 0.15 microgram/milliliter (µg/mL).

Time frame: At Month 3

Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies

The vaccine response was defined as it follows: * for PT and FHA, an antibody concentration higher than or equal to (≥) 20 EL.U/mL at post-vaccination; * for PRN, at least a 4-fold increase in antibody concentration from pre-vaccination to post-vaccination time points.

Time frame: At Month 3

Secondary Outcomes

Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1.0 µg/mL

The number of subjects with anti-PRP antibody concentrations higher than or equal to (≥) 1.0 µg/mL post primary vaccination is reported.

Time frame: At Month 3

Concentrations for Anti-D and Anti-T Antibodies

Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International units per milliliter (IU/mL).

Time frame: At Month 0 and Month 3

Concentrations for Anti-PRP Antibodies

Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram/milliliter (µg/mL).

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: At Month 0 and Month 3

Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies

Anti-PT, anti-FHA and anti-PRN antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

Time frame: At Month 3

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.

Time frame: During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Assessed solicited general symptoms were drowsiness, fever \[defined as axillary temperature equal to or above (≥) 37.1 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever above (\>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

Time frame: During the 4-day (Day 0-3) follow-up 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.

Time frame: During the 31-day (Day 0-30) follow-up period after each vaccination

Number of Subjects With Serious Adverse Events (SAEs)

SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Time frame: From receipt of first dose of study vaccine (Day 0) to study end (Month 3)