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Phase 3 N=168 Randomized Prevention

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

Infections, Meningococcal

Enrolled (actual)
168
Serious AEs
1.8%
Results posted
Mar 2017
Primary outcome: Primary: Number of Subjects With Serum Bactericidal Assay Against N. Meningitidis Serogroups A, C Using Rabbit Complement (rSBA-MenA,C) Antibodies — 65; 59; 30; 66 Subjects

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Tritanrix™- HepB (Biological); Hiberix™ (Biological); Mencevax™ ACW (Biological)
Age
Pediatric · 0+ yrs
Sex
All
Sponsor
GlaxoSmithKline
Primary completion
May 2007

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Subjects With Serum Bactericidal Assay Against N. Meningitidis Serogroups A, C Using Rabbit Complement (rSBA-MenA,C) Antibodies
65; 59; 30; 66
SECONDARY
Number of Subjects With rSBA-MenA,C, W-135 Antibody Titers ≥ Predefined Cut-offs
55; 50; 65; 60; 54; 48
SECONDARY
Anti-rSBA-MenA, C, W-135 Antibody Titers
503.8; 509.9; 1871.7; 1562.0; 6.7; 50.7
SECONDARY
Number of Subjects With Anti-polysaccharide A (Anti-PSA) and C (Anti-PSC) Antibody Concentrations Above Predefined Cut-off Values
8; 10; 62; 64; 0; 1
SECONDARY
Anti-PSA and Anti-PSC Antibody Concentrations
0.18; 0.19; 6.61; 22.39; 0.18; 0.35
SECONDARY
Number of Subjects With Anti- Polysaccharide W (Anti-PSW) Antibody Concentrations ≥ Predefined Cut-off Values
0; 2; 64; 64
SECONDARY
Anti-PSW Antibody Concentrations
0.15; 0.16; 4.89; 5.19
SECONDARY
Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Predefined Cut-off Values
63; 65
SECONDARY
Anti-HBs Antibody Concentrations
722.0; 713.1
SECONDARY
Number of Subjects With Vaccine Response for rSBA-Men A, C and W-135
26; 21; 41; 56; 41; 32
SECONDARY
Number of Subjects With Fever
33; 29
SECONDARY
Number of Subjects With Solicited Local Symtoms
21; 25; 20; 16; 13; 11
SECONDARY
Number of Subjects With Solicited General Symptoms
14; 12; 8; 5; 15; 12
SECONDARY
Number of Subjects With Unsolicited Adverse Events (AEs)
10; 16
SECONDARY
Number of Subjects With Serious Adverse Events (SAEs)
2; 1

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.

Eligibility 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00317109). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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