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

Phase IIIb, Multicentre Study to Assess Safety & Immunogenicity of GSK Biologicals' Combined DTPa/Hib (Infanrix/Hib) Vaccine vs Separate Administration of DTPa (Infanrix) & Hib (Hiberix) Vaccines in Healthy Infants 3,4,&5 Months of Age as Compared With the Separate Administration of DTPa and Hib Vaccines at Different Injection Sites.

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 Overview

• Status: Completed
• Conditions: Tetanus; Diphtheria; Acellular Pertussis
• Intervention / Treatment: Biological: Infanrix; Biological: Infanrix™/Hib; Biological: Hiberix

• Study Type: Interventional
• Enrollment (Actual): 660
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Mengshan, China
    • GSK Investigational Site
  • Wuzhou, China
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 3 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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.	At Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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).	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).	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.	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.	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.	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.	From receipt of first dose of study vaccine (Day 0) to study end (Month 3)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Li YP, Zhang SM, Ye Q. [Safety and immunogenicity of the diphtheria, tetanus, accellular pertussis plus hemophilus influenza type b combined vaccine (DTaP-Hib) to Chinese infants]. Zhongguo Yi Miao He Mian Yi. 2010 Apr;16(2):97-104. Chinese.

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start: January 3, 2007
• Primary Completion (Actual): June 1, 2007
• Study Completion (Actual): June 25, 2007

Study Registration Dates

• First Submitted: December 18, 2006
• First Submitted That Met QC Criteria: December 18, 2006
• First Posted (Estimate): December 19, 2006

Study Record Updates

• Last Update Posted (Actual): June 6, 2018
• Last Update Submitted That Met QC Criteria: April 26, 2018
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Corynebacterium Infections; Diphtheria
• Other Study ID Numbers: 104567

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Statistical Analysis Plan
   Information identifier: 104567
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Clinical Study Report
   Information identifier: 104567
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Individual Participant Data Set
   Information identifier: 104567
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Dataset Specification
   Information identifier: 104567
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Informed Consent Form
   Information identifier: 104567
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Study Protocol
   Information identifier: 104567
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Annotated Case Report Form
   Information identifier: 104567
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register