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Immune Response & Safety of GSK Biologicals' Mencevax™ ACWY in Subjects Primed in the DTPW-HBV=HIB-MENAC-TT-011 Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00291343
First Posted: February 14, 2006
Last Update Posted: August 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
This study will be conducted in three stages. In the DTP booster stage at 15 to 24 months of age, all subjects will receive a booster dose of Tritanrix™-HepB/Hiberix™. In the Mencevax™ ACWY "full dose" stage at 24 to 30 months of age all subjects will receive a dose of Mencevax™ ACWY. In the Mencevax™ ACWY "small dose" stage at 30 to 36 months of age, the first 75 subjects in each of the two centers will be tested for boostability of the MenA and MenC immune response by giving a fifth of a dose of a Mencevax™ ACWY vaccine. 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™ ACWY Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Booster Vaccination Study to Assess Immunogenicity & Safety of a Dose of GSK Biologicals' Mencevax™ ACWY & 1/5th of a Dose of Mencevax™ ACWY in Subjects Primed in the DTPW-HBV=HIB-MENAC-TT-011 Study

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Subjects With Serum Bactericidal Activity Against Neisseria Meningitidis Serogroups A, C (rSBA-MenA, C) Using Rabbit Complement Antibodies [ Time Frame: 1 month after Mencevax™ ACWY vaccination (at 25 to 31 months of age). ]
    Antibody cut-offs were higher than or equal to (≥) 1:128


Secondary Outcome Measures:
  • Number of Subjects With Anti-rSBA-MenA, C Antibody Titers ≥ Pre-defined Cut-off Values [ Time Frame: Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax™ ACWY vaccination. ]
    Pre-defined cut-offs were ≥ 1:8 and ≥ 1:128

  • Anti-rSBA-MenA, C Antibody Titers [ Time Frame: Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax™ ACWY vaccination. ]
    Antibody titers were expressed as Geometric Mean Titers (GMTs)

  • Number of Subjects With Anti-pilysaccharide A and C (Anti-PSA/PSC) Antibody Concentrations ≥ Predefined Cut-off Values [ Time Frame: Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax™ ACWY vaccination. ]
    Antibody cut-offs were ≥ 0.3, 2 micrograms per millilitre (µg/mL).

  • Anti-PSA, Anti-PSC Antibody Concentrations [ Time Frame: Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax™ ACWY vaccination. ]
    Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).

  • Number of Subjects With Anti-hepatitis B Surface (Anti-HBs) Antigen Antibody Concentrations ≥ Cut-offs [ Time Frame: Prior to the Mencevax™ ACWY vaccination at 24-30 Months of age ]
    The antibody concentrations cut-off was ≥ 10 milli international units per millilitre (mIU/mL).

  • Anti-HBs Concentrations [ Time Frame: Prior to the Mencevax™ ACWY vaccination at 24-30 Months of age ]
    Antibody concnetrations were expressed as Geometric Mean Concentrations (GMCs).

  • Number of Subjects With Vaccine Response for rSBA-Men A, C [ Time Frame: 1 month after Mencevax™ ACWY vaccination (at 25 to 31 months of age). ]
    Vaccine response was defined as follows: for initially seronegative subjects (i.e. with rSBA titer < 1:8 pre-vaccination), rSBA titer ≥ 1:32 post-vaccination (seroconversion), and for initially seropositive subjects (i.e. with rSBA > 1:8 prevaccination), at least a 4-fold increase in rSBA titer from pre-vaccination to post-vaccination.

  • Number of Subjects With Solicited Local Symptoms [ Time Frame: During the 4-day follow-up period after the Mencevax™ ACWY vaccination, at 24-30 months of age ]
    Assessed solicited local symptoms were pain, redness, swelling. Any = symptom occurring regardless of intensity grade.

  • Number of Subjects With Solicited General Symptoms [ Time Frame: During the 4-day follow-up period after the Mencevax™ ACWY vaccination, at 24-30 months of age ]
    Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, rectal fever [≥ 38 degrees Celsius (°C)]. Any = occurrence of symptom regardless of intensity grade.

  • Number of Subjects With Unsolicited Adverse Events (AEs) [ Time Frame: From Day 0 at months 15-24 of age to study end at Months 25-31 of age ]
    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 is defined as the occurrence of any unsolicited AE regard-less of intensity grade or relation to vaccination.

  • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: From 15-24 Months of age up to Months 25-31 of age ]
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.


Enrollment: 296
Study Start Date: February 1, 2006
Study Completion Date: March 15, 2007
Primary Completion Date: March 15, 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TRITANRIX™-HEPB/HIB-MENAC +MENCEVAX™ ACWY GROUP
Subjects previously primed with 3 doses of Tritanrix™-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
Biological: Tritanrix™- HepB
One intramuscular dose during the booster vaccination study in subjects aged 15 to 24 months
Biological: Hiberix™
One intramuscular dose during the booster vaccination study in subjects aged 15 to 24 months
Biological: Mencevax™ ACWY
One full subcutaneous dose in subjects aged 24 to 30 months or 1/5th of a dose intramuscular in subjects aged 30 to 36 months
Active Comparator: TRITANRIX™-HEPB/HIBERIX™+MENCEVAX™ ACWY GROUP
Subjects previously primed with 3 doses Tritanrix™-HepB/Hiberix™ vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age.
Biological: Tritanrix™- HepB
One intramuscular dose during the booster vaccination study in subjects aged 15 to 24 months
Biological: Hiberix™
One intramuscular dose during the booster vaccination study in subjects aged 15 to 24 months
Biological: Mencevax™ ACWY
One full subcutaneous dose in subjects aged 24 to 30 months or 1/5th of a dose intramuscular in subjects aged 30 to 36 months

Detailed Description:

Subjects in the group that was previously primed with Tritanrix™-HepB/Hiberix™ will be the control group for the group that was previously primed with Tritanrix™-HepB/Hib-MenAC.

Blood samples will be drawn from subjects as follows:

  • prior to and one month after the full dose of the Mencevax™ ACWY vaccine.
  • prior to and one month after 1/5th of a dose of Mencevax™ ACWY vaccine (only for the first 75 subjects in each of the two centers).
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   15 Months to 24 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 24 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 DTPW-HBV=HIB-MENAC-TT-011 (eTrack No. 100478) in Center No. 4328 or Center No.4329.

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; with the exception of oral poliovirus vaccine (OPV).
  • Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A and/or C disease, after the date of the study conclusion visit of the primary vaccination study DTPW-HBV=HIB-MENAC-TT-011 (eTrack No. 100478).
  • History of diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A or C disease.
  • Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A or C 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 vaccine.
  • 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.
  • Planned or actual administration of immunoglobulins and/or any blood products within the three months preceding Mencevax™ ACWY vaccination.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00291343


Locations
Philippines
GSK Investigational Site
Manila, Philippines, 1000
GSK Investigational Site
Sampaloc, Manila, Philippines, 1008
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: 105239 (mth24-30)
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: 105239 (mth24-30)
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 105239 (mth24-30)
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: 105239 (mth24-30)
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: 105239 (mth24-30)
For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 105239 are summarised with study 105245 on the GSK Clinical Study Register.
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 105239 (mth24-30)
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00291343     History of Changes
Other Study ID Numbers: 105239 (mth24-30)
105245 ( Other Identifier: GSK )
First Submitted: February 13, 2006
First Posted: February 14, 2006
Results First Submitted: January 12, 2017
Results First Posted: August 3, 2017
Last Update Posted: August 3, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
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:
hepatitis B
meningococcal vaccine
pertussis
Prophylaxis diphtheria
meningococcal serogroups A and C diseases
tetanus
Haemophilus influenzae type b

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