Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y MedDRA version: 18.0 Level: LLT Classification code 10028911 Term: Neisseria meningitidis infection NOS System Organ Class: 100000004862 MedDRA version: 18.0 Level: LLT Classification code 10018953 Term: Haemophilus influenzae meningitis System Organ Class: 100000004862 MedDRA version: 18.0 Level: LLT Classification code 10018952 Term: Haemophilus influenzae infection System Organ Class: 100000004862
Conditions
Interventions
Product Name: HibMenCY-TT
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: -
Current Sponsor code: MenC-TT
Other descriptive name: N. MENINGITIDIS GROUP C (STRAI
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol. • A male or female between, and including, 6 and 12 weeks of age at the time of the first 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. • Born after 36 weeks gestation. • Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrolment. • Infants may have received a birth dose of Bacillus Calmette-Guérin (BCG) vaccine. Are the trial subjects under 18? yes Number of subjects for this age range: 4053 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preced-ing the first dose of study vaccine, or planned use during the study period. • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. • Planned administration/ administration of a vaccine not fore-seen by the study protocol within 30 days of the first dose of study vaccine(s). • Previous vaccination against Neisseria meningitidis, Haemo-philus influenzae type b, diphtheria, tetanus, pertussis, and/or poliovirus; more than one previous dose of hepatitis B vaccine. • In country(ies) where Prevnar will be provided by GSK Biologicals, previous vaccination with Prevnar. • History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, and/or poliovirus disease. • Any confirmed or suspected immunosuppressive or immuno-deficient condition based on medical history and physical examination. • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including dry natural latex rubber. • Major congenital defects or serious chronic illness. • History of any neurologic disorders or seizures. • Acute disease at time of enrollment. • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. • Concurrent participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Occurrence of SAEs Occurrence of specific adverse events of new onset of chronic illness(es), rash, and conditions prompting emergency room visits ;Timepoint(s) of evaluation of this end point: From dose 1 up to Day 30 after dose 3 and from Dose 1 up to the day preceding the fourth dose. From dose 1 up to Day 30 after dose 3 and from Dose 1 up to the day preceding the fourth dose.;Main Objective: Occurrence of SAEs from dose 1 up to Day 30 after dose 3 and from Dose 1 up to the day preceding the fourth dose. Occurrence of specific adverse events of new onset of chronic illness(es), rash, and conditions prompting emergency room visits from dose 1 up to Day 30 after dose 3 and from Dose 1 up to the day preceding the fourth dose.;Secondary Objective: Occurrence of SAEs from the fourth dose up to Day 30 after the fourth dose vaccination and from the fourth dose up to 6 months after the fourth dose vaccination. Occurrence of specific adverse events of new onset of chronic illness(es), rash, and conditions prompting emergency room visits from the fourth dose up to Day 30 after the fourth dose vaccination and from the fourth dose up to 6 months after the fourth dose vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Occurrence of SAEs. Occurrence of specific adverse events of new onset of chronic illness(es), rash, and conditions prompting emergency room visits. ;Timepoint(s) of evaluation of this end point: From the fourth dose up to Day 30 after the fourth dose vac-cination and from the fourth dose up to 6 months after the fourth dose vaccination. From the fourth dose up to Day 30 after the fourth dose vac-cination and from the fourth dose up to 6 months after the fourth dose vaccination. | — |
Countries
Mexico, United States
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed