Persistence of antibodies after a 3-dose primary vaccination (in infancy) with or without a booster vaccination (in the second year of life) against Haemophilus influenzae type b disease and meningococcal disease due to serogroup C
Conditions
Interventions
Trade Name: Infanrix IPV
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Diphteria toxoid
Current Sponsor code: D
Oth
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All subjects must satisfy the following criteria at study entry: Subjects of groups HibMenC and LicMenC at Visits 1, 2 and 3: •Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. return for follow-up visits) should be enrolled in the study. •A male or female between and including 24 and 31 months of age at the time of Visit 1, between and including 40 and 43 months of age at Visit 2 and between and including 60 and 64 months at Visit 3. •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 completed the booster vaccination study HIB-MENC-TT-013 BST:012. Subjects of group NoBoost at Visit 2 (UK only): •Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. •A male or female between and including 40 and 43 months of age at Visit 2. •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 received a 3-dose primary vaccination with a MenC conjugate vaccine and a Hib containing vaccine before the age of 8 months. Are the trial subjects under 18? yes Number of subjects for this age range: 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: The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study: Subjects of groups HibMenC and LicMenC at Visits 1, 2 and 3: •Previous administration of a booster dose of Hib or meningococcal serogroup C except booster study vaccines during the study HIB-MENC-TT-013 BST:012. •History of H. influenzae type b or meningococcal diseases. •UK subjects only: previous administration of a booster dose of a pertussis-containing vaccine, except booster study vaccines during the study HIB-MENC-TT-013 BST:012 (104056) Subjects of group NoBoost at Visit 2 (UK only): •Previous administration of a booster dose of Hib or meningococcal serogroup C vaccine •History of H. influenzae type b or meningococcal diseases The following criteria should be checked at each visit subsequent to the first visit for subjects in groups HibMenC and LicMenC: •History of H. influenzae type b, meningococcal or pertussis diseases* since the previous long-term persistence visit [for the Visit1 - since the last visit of the booster vaccination study 104056 (HIB-MENC-TT-013 BST:012)]. * Subjects with a history of pertussis disease will be eliminated from the pertussis analyses only. See Section 9.3. •Previous administration of a booster dose of Hib or meningococcal serogroup C vaccines since the previous long-term persistence visit. •UK subjects only: Prior to Visit 2: previous administration of pertussis containing vaccine as booster vaccination. •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since the last visit. (For corticosteroids, this will mean prednisone, or equivalent, ?0.5 mg/kg/day. Inhaled and topical steroids are allowed.). •Administration of immunoglobulins and/or any blood products since the last visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In all evaluable subjects of groups HibMenC and LicMenC at 12 months after the booster vaccination; in all evaluable subjects of groups HibMenC and LicMenC at 24 months after the booster vaccination; in all evaluable subjects of group NoBoost at 40-43 months of age; and in all evaluable subjects of groups HibMenC and LicMenC at 48 months after the booster vaccination: • To evaluate the persistence of meningococcal C antibodies • To evaluate the persistence of Haemophilus influenzae type b antibodies. In all UK evaluable subjects* of groups HibMenC and LicMenC: • To evaluate the persistence of anti-pertussis antibodies prior to Infanrix-IPV preschool booster and the response to Infanrix-IPV preschool booster 24 months later. * UK pediatric vaccination schedule recommends a DTP booster at the moment of Visit 2 (24 months after study booster vaccination) of our study; the Polish pediatric vaccination schedule recommends a DTP booster before Visit 1 of our study. ;Secondary Objective: ; Primary end point(s): Immunogenicity endpoints: In all subjects of groups HibMenC and LicMenC, at Visit 1, Visit 2 and Visit 3 (i.e. at 12, 24 and 48 months, respectively, after the Hib-MenC booster) and in all subjects of group NoBoost at 40-43 months of age (Visit 2): • SBA-MenC titre >= 1:8 (seroprotection) and >= 1:128 and titres. • Anti-PRP concentration >= 0.15 microg/ml (seroprotection) and >= 1.0 microg/ml and concentrations. • Anti-PSC concentration >= 0.30 microg/ml (seropositivity) and >= 2.0 microg/ml and concentrations. In all UK subjects of groups HibMenC and LicMenC at Visit 2 (24 months after Hib-MenC booster and prior to Infanrix-IPV booster) and at Visit 3 (48 months after Hib-MenC booster and 24 months after Infanrix-IPV booster): • Anti-FHA, anti-PRN a | — |
Countries
United Kingdom
Outcome results
None listed