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Study to Asses DTPw-HBV/Hib at 15-18 Months (m) and Mencevax™ ACW at 24 to 30 m in Primed Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00317109
First received: February 3, 2006
Last updated: January 10, 2017
Last verified: October 2016
  Purpose

The purpose of this study is to assess the safety and reactogenicity of a booster dose of diphtheria-tetanus-whole cell pertussis-hepatitis B virus/Haemophilus influenzae type b vaccine (DTPw-HBV/Hib) at 15-18 m and to assess the immunogenicity, safety, and reactogenicity of a dose of Mencevax™ Group A, C and W135 polysaccharide meningococcal vaccine (ACW) at 24 to 30 m in primed subjects.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Condition Intervention Phase
Infections, Meningococcal Biological: Tritanrix™- HepB Biological: Hiberix™ Biological: Mencevax™ ACW Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Booster Vaccination Study to Assess Safety & Reactogenicity of a Dose of DTPw-HBV/Hib Vaccine and to Assess the Immunogenicity, Safety & Reactogenicity of a Dose of Mencevax™ ACW in Subjects Primed in Study 759346/007

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Subjects With Serum Bactericidal Assay Against N. Meningitidis Serogroups A, C Using Rabbit Complement (rSBA-MenA,C) Antibodies [ Time Frame: At one month post vaccination with Mencevax™ ACW vaccine (Month 25-31) ]
    Pre-defined assay cut-off values for assessed titers were greater than or equal to (≥) 1:128.


Secondary Outcome Measures:
  • Number of Subjects With rSBA-MenA,C, W-135 Antibody Titers ≥ Predefined Cut-offs [ Time Frame: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31) ]
    Antibody titer cut-offs were ≥ 1:8 and ≥ 1:128.

  • Anti-rSBA-MenA, C, W-135 Antibody Titers [ Time Frame: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31) ]
    Antibody titers were expressed as geometric mean titers (GMTs).

  • Number of Subjects With Anti-polysaccharide A (Anti-PSA) and C (Anti-PSC) Antibody Concentrations Above Predefined Cut-off Values [ Time Frame: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31) ]
    Antibody concentrations cut-off were ≥ 0.3 and ≥2 micrograms per millilitre (µg/mL).

  • Anti-PSA and Anti-PSC Antibody Concentrations [ Time Frame: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31 ]
    Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).

  • Number of Subjects With Anti- Polysaccharide W (Anti-PSW) Antibody Concentrations ≥ Predefined Cut-off Values [ Time Frame: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31) ]
    Antibody concentrations were ≥ 0.3 µg/mL.

  • Anti-PSW Antibody Concentrations [ Time Frame: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31) ]
    Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).

  • Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Predefined Cut-off Values [ Time Frame: Prior to (Months 24-30) the administration of the Mencevax™ ACW vaccine ]
    Antibody concentrations cut-off were ≥ 10 milli international units per milliliter (mIU/mL).

  • Anti-HBs Antibody Concentrations [ Time Frame: Prior to (Months 24-30) the administration of the Mencevax™ ACW vaccine ]
    Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).

  • Number of Subjects With Vaccine Response for rSBA-Men A, C and W-135 [ Time Frame: At one month after the administration of the Mencevax™ ACW vaccine (Months 25-31) ]
    Vaccine response was defined as follows: for initially seronegative subjects (i.e. with rSBA titre < 1:8 pre-vaccination), rSBA titre ≥ 1:32 post-vaccination (seroconversion), and for initially seropositive subjects (i.e. with rSBA titre ≥ 1:8 pre-vaccination), at least a 4-fold increase in rSBA titre from pre to post-vaccination.

  • Number of Subjects With Fever [ Time Frame: During the 4-day (Days 0-3) after the administration of the Tritanrix™-HepB/Hiberix™ vaccine ]
    Any Fever (measured rectally) = subjects with symptom, regardless of the intensity grade.

  • Number of Subjects With Solicited Local Symtoms [ Time Frame: During the 4-Day (Days 0-3) after the administration of the Mencevax™ ACW vaccine ]
    Assessed solicited local symptoms were: pain, redness and swelling at the injection site. Any = subjects with symptom, regardless of the intensity grade.

  • Number of Subjects With Solicited General Symptoms [ Time Frame: During the 4-Day (Days 0-3) after the administration of the Mencevax™ ACW vaccine ]
    Assessed solicited general symptoms were: drowsiness, fever, irritability and loss of appetite. Any = subjects with symptoms, regardless of intensity grade and casual relationship to study vaccination.

  • Number of Subjects With Unsolicited Adverse Events (AEs) [ Time Frame: During the 31-Day (Days 0-30) after the administration of the Mencevax™ ACW vaccine ]
    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 Months 15-18 and up to Months 25-31 post vaccination ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.


Enrollment: 168
Study Start Date: April 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AC primed Group Biological: Tritanrix™- HepB
One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months
Biological: Hiberix™
One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months
Biological: Mencevax™ ACW
One subcutaneous dose during the booster vaccination study in subjects aged 24 to 30 months
Active Comparator: AC unprimed Group Biological: Tritanrix™- HepB
One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months
Biological: Hiberix™
One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months
Biological: Mencevax™ ACW
One subcutaneous dose during the booster vaccination study in subjects aged 24 to 30 months

Detailed Description:

This open study will have two parallel groups based on the vaccination received in the primary study: AC primed Group: primed with Tritanrix™-HepB/Hib-MenAC vaccine and AC unprimed Group (control): primed with Tritanrix™-HepB/Hiberix™ vaccine. All subjects will receive a booster dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age with GSK Biological's OPV vaccine given concomitantly and a dose of Mencevax™ ACW vaccine at 24 to 30 months of age. Blood sampling will be done prior to (pre) and one month after (post) the Mencevax™ ACW vaccine administration for immunogenicity analyses. The study will last minimum 7 to maximum 16 months per subject.

Mencevax™ ACWY was changed to Mencevax™ ACW throughout the posting to correct an inconsistency in the earlier version of the protocol posting and to reflect the actual situation.

  Eligibility

Ages Eligible for Study:   15 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
  • A male or female between, and including, 15 and 18 months of age at the time of vaccination.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Having participated in the primary vaccination study (CPMS N° 759346/007).

Exclusion criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the vaccination, or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of vaccination.
  • Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A, C or W disease, after the date of the study conclusion visit of the primary vaccination study (CPMS N° 759346/007).
  • History of diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A, C or W disease.
  • Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A, C or W disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • A family history of congenital or hereditary immunodeficiency.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines administered in the study.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures including febrile seizures in infancy.
  • Acute disease at the time of enrolment.
  • Axillary temperature ≥ 37.5°C at the time of vaccination.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the vaccination or planned administration during the study period.
  • Anaphylactic reaction following the administration of vaccine in the primary vaccination study.
  • Known hypersensitivity to any component of the vaccine, or subjects having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B, Hib or meningococcal vaccines.
  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: NCT00317109

Locations
South Africa
GSK Investigational Site
Brits, South Africa, 0250
GSK Investigational Site
Ga-Rankuwa, South Africa, 0208
GSK Investigational Site
Rooihuiskraal, South Africa, 0145
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 104756
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 104756
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 104756
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: 104756
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: 104756
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: 104756
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00317109     History of Changes
Other Study ID Numbers: 104756
Study First Received: February 3, 2006
Results First Received: January 10, 2017
Last Updated: January 10, 2017
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.

Keywords provided by GlaxoSmithKline:
meningococcal serogroups A and C diseases
tetanus
hepatitis B
pertussis
Haemophilus influenzae type b
meningococcal vaccine
Prophylaxis diphtheria

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 23, 2017