Infants from 3 months up to 23 months of age who may benefit from active immunization against disease caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media) and who would be scheduled to receive Prevenar PCV-7.
Conditions
Interventions
Trade Name: Prevenar
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Prevenar
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (7-VALENT, ADSORBED)
Concentrati
Sponsors
Pfizer Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Infants from 3 months up to 23 months of age who may benefit from active immunization against disease caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media) and who would be scheduled to receive Prevenar PCV-7. 2. Parents or legal guardians must be willing and able to complete the diary cards This is consistent with previous and ongoing studies, and is consistent with the anticipated Russian label. Are the trial subjects under 18? yes Number of subjects for this age range: 100 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: 1. Hypersensitivity to the active substances or to any of the excipients. 2. Hypersensitivity to diphtheria toxoid 3. Age less than 3 months or greater than or equal to 2 years at enrollment Contraindications as listed in the Package Insert / Russian SmPC for either Prevenar or for any concomitantly used other vaccines 4. Previously vaccinated with 23-valent pneumococcal polysaccharide vaccine 5. Current febrile illness (temperature greater than or equal to 38.0°C [100.4°F]) or other acute illness within 48 to 72 hours before Prevenar administration. 6. Prophylactic use of non-steroidal anti-inflammatory medications and/or acetaminophen (e.g., paracetamol). However, acetaminophen/paracetamol may be administered for treatment of fever, pain, etc. 7. The vaccine should not be given to infants or children with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection. 8. Received any investigational drugs, live vaccines or devices within 4 weeks before administration of the vaccine, other than on the day of study vaccination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to estimate the incidence of febrile reactions of =38 to =39°C; >39 to =40°C; >40°C occurring within 2 days following vaccination with Prevenar (PCV-7) coadministered with other routine childhood vaccines under the conditions of routine daily use in the Russian Federation within the licensed indication;Secondary Objective: To observe the frequency and severity of other local and/or systemic reactions and undesirable effects for two days after routine vaccination with PCV-7 a) Local reaction at the site of injection: Redness or induration = 2cm in diameter, swelling including extent of swelling, transient tenderness and tenderness that interfered with limb movement. b) Systemic reaction: - to monitor the rate of other systemic reactions such as restless sleep, decreased appetite, unusual irritability/fussiness/crying, vomiting, diarrhea, drowsiness, other. ;Primary end point(s): 1)The incidence of febrile reactions more than 38.0 degrees Celsius, 2)To observe the frequency and severity of other local and/or systemic reactions and undesirable effects for two days after routine vaccination with PCV-7 3) Safety Analysis The following adverse events will be evaluated: Local reaction at the site of injection Redness including extent or redness Swelling including extent of swelling Induration Tenderness Systemic reaction Fever Decreased/increased need for sleep (restless sleep) Decreased Appetite Unusual irritability/fussiness/crying Vomiting Diarrhea Incidence of adverse events (as defined above) will be tabulated. Incidence of adverse events will be tabulated by subject’s baseline characteristics (age and sex), existence of co-morbid conditions, existence of concomitant medications, existence of concomitant vaccine and type, etc. ;Timepoint(s) of evaluation of this end point: Subjects will be observed in the healthcare centre for 30 minutes following vaccination for immediate local or systemic reactions. Safety evaluation will | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): NONE;Timepoint(s) of evaluation of this end point: Not Applicable | — |
Countries
Russian Federation
Contacts
Public ContactClinical Trials.gov Call Center
Pfizer Inc.
Outcome results
None listed