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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00412854
First received: December 18, 2006
Last updated: December 20, 2016
Last verified: November 2016
  Purpose
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.

Condition Intervention Phase
Tetanus
Diphtheria
Acellular Pertussis
Biological: Infanrix™/Hib
Biological: Infanrix
Biological: Hiberix
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Seroprotected Subjects Against Diphteria Toxoid (D) and Tetanus Toxoid (T) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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:
  • Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1.0 µg/mL [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.


Enrollment: 660
Study Start Date: January 2007
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   90 Days to 120 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00412854

Locations
China
GSK Investigational Site
Mengshan, China
GSK Investigational Site
Wuzhou, China
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Yan-Ping Li, Shumin Zhang, Qiang Ye, Qiming Hou, Yanan Li, Hong Li, Yinghua Xu, Xiao Ma, Youping Liu, Xiaoling Chen, Lirong Huang, Gunasekaran Ramakrishnan, Richard Zhao, Haiwen Tang, Olivier Van Der Meeren, Hans L Bock.Combined diphtheria-tetanus-acellular pertussis vaccine mixed with Haemophilus influenzae type b conjugate vaccine is safe and immunogenic in two studies in Chinese infants.Chinese Journal of Vaccines - Zhongguo Yi Miao He Mian Yi (Zhongguo Ji Hua Mian Yi). Zhongguo Yi Miao He Mian Yi. 2010 Apr;16(2):97-104

Study Data/Documents: Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 104567
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 104567
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 104567
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 104567
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 104567
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 104567
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 104567
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00412854     History of Changes
Other Study ID Numbers: 104567
Study First Received: December 18, 2006
Results First Received: December 20, 2016
Last Updated: December 20, 2016
Individual Participant Data  
Plan to Share IPD: Yes
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.

Additional relevant MeSH terms:
Diphtheria
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on March 24, 2017