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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

Phase 3
Completed
Conditions
Infections, Meningococcal
Interventions
Biological: Tritanrix™- HepB
Biological: Hiberix™
Biological: Mencevax™ ACW
Registration Number
NCT00317109
Lead Sponsor
GlaxoSmithKline
Brief Summary

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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
168
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.
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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
AC primed GroupMencevax™ ACW-
AC primed GroupTritanrix™- HepB-
AC primed GroupHiberix™-
AC unprimed GroupHiberix™-
AC unprimed GroupMencevax™ ACW-
AC unprimed GroupTritanrix™- HepB-
Primary Outcome Measures
NameTimeMethod
Number of Subjects With Serum Bactericidal Assay Against N. Meningitidis Serogroups A, C Using Rabbit Complement (rSBA-MenA,C) AntibodiesAt 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
NameTimeMethod
Number of Subjects With rSBA-MenA,C, W-135 Antibody Titers ≥ Predefined Cut-offsPrior 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.

Number of Subjects With Anti-polysaccharide A (Anti-PSA) and C (Anti-PSC) Antibody Concentrations Above Predefined Cut-off ValuesPrior 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).

Number of Subjects With Anti- Polysaccharide W (Anti-PSW) Antibody Concentrations ≥ Predefined Cut-off ValuesPrior 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 ConcentrationsPrior 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 Solicited Local SymtomsDuring 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.

Anti-PSA and Anti-PSC Antibody ConcentrationsPrior 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).

Anti-rSBA-MenA, C, W-135 Antibody TitersPrior 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 Vaccine Response for rSBA-Men A, C and W-135At 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 Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Predefined Cut-off ValuesPrior to (Months 24-30) the administration of the Mencevax™ ACW vaccine

Antibody concentrations cut-off were ≥ 10 milli international units per milliliter (mIU/mL).

Number of Subjects With Solicited General SymptomsDuring 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)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.

Anti-HBs Antibody ConcentrationsPrior to (Months 24-30) the administration of the Mencevax™ ACW vaccine

Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).

Number of Subjects With FeverDuring 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 Serious Adverse Events (SAEs)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.

Trial Locations

Locations (1)

GSK Investigational Site

🇿🇦

Rooihuiskraal, South Africa

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