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

Phase 3

Completed

• Conditions: Tetanus; Diphtheria; Acellular Pertussis

• Registration Number: NCT00412854
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-12-18
• Study First Submitted QC: 2006-12-18
• Study First Posted: 2006-12-19
• Study Start: 2007-01-03
• Primary Completion: 2007-06-01
• Study Completion: 2007-06-25
• Status Verified: 2016-12
• Results First Submitted: 2016-12-20
• Results First Submitted QC: 2016-12-20
• Results First Posted: 2017-02-10
• Last Update Submitted: 2018-04-26
• Last Update Posted: 2018-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 660

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Seroprotected Subjects Against Diphteria Toxoid (D) and Tetanus Toxoid (T)	At Month 3	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).
Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP)	At Month 3	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).
Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies	At Month 3	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.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1.0 µg/mL	At Month 3	The number of subjects with anti-PRP antibody concentrations higher than or equal to (≥) 1.0 µg/mL post primary vaccination is reported.
Concentrations for Anti-D and Anti-T Antibodies	At Month 0 and Month 3	Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International units per milliliter (IU/mL).
Concentrations for Anti-PRP Antibodies	At Month 0 and Month 3	Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram/milliliter (µg/mL).
Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies	At Month 3	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).
Number of Subjects With Any and Grade 3 Solicited Local Symptoms	During the 4-day (Day 0-3) follow-up 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. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses	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.
Number of Subjects With Unsolicited Adverse Events (AEs)	During the 31-day (Day 0-30) follow-up period after each vaccination	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)	From receipt of first dose of study vaccine (Day 0) to study end (Month 3)	SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Trial Locations

Locations (1)

GSK Investigational Site; 🇨🇳 Wuzhou, China