- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00488800
Safety and Local Tolerability of Prevenar in Indian Children
A Postmarketing Surveillance Study Evaluating the Safety and Local Tolerance of PREVENAR in Indian Children
This postmarketing surveillance study will evaluate the safety profile of Prevenar in Indian children.
Prevenar is indicated for active immunization of infants and children from 6 weeks of age through 9 years of age against invasive disease (including meningitis, bacteraemic pneumonia, bacteraemia, sepsis) caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F.
Prevenar has been marketed in India since June 2006. The Board of Health in India has given restricted permission to import and market Prevenar. The present study is a post-approval regulatory commitment to the Board of Health in India.
This is an observational study and the protocol for the study has been approved by the Board of Health.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
INCLUSION CRITERIA
Subjects must meet at least one of the following conditions to be eligible for inclusion in the study:
For Primary Immunization Schedule:
- Healthy male or female subjects 6 weeks + 5 days of age with no previous PREVENAR vaccination
- For Catch-up Immunization Schedule:
- Healthy male or female subjects 12-23 months of age
EXCLUSION CRITERIA Subjects with any of the following conditions or characteristics will be excluded from the study.
- A known or suspected history of Streptococcus pneumoniae disease.
- A previous anaphylactic or other severe vaccine-associated adverse event.
- A known or suspected impairment of immune system (including HIV infection), or recipient of immunosuppressive agents.
- A major congenital, developmental or serious chronic disorder.
- A confirmed or suspected underlying evolving neurological disorder or history of seizures.
- A history of thrombocytopenia or any coagulation disorder.
- Any acute illness at the time of vaccine administration
Studieplan
Hur är studien utformad?
Designdetaljer
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 0887X-102324
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