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Safety and Local Tolerability of Prevenar in Indian Children

Last updated on December 3, 2019

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-24 weeks
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

NCT00488800
Pfizer
Completed
Safety and Local Tolerability of Prevenar in Indian Children

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Descriptive Information
Brief TitleSafety and Local Tolerability of Prevenar in Indian Children
Official TitleA Postmarketing Surveillance Study Evaluating the Safety and Local Tolerance of PREVENAR in Indian Children
Brief Summary

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.

Detailed DescriptionNot Provided
Study TypeObservational
Study DesignTime Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNot Provided
Study PopulationNot Provided
ConditionPneumococcal Infections
InterventionBiological: pneumococcal conjugate vaccine
Study Groups/CohortsNot Provided
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Enrollment
 (submitted: June 19, 2007)
1000
Original EnrollmentSame as current
Actual Study Completion DateJanuary 2007
Actual Primary Completion DateJanuary 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study:All
Ages6 Weeks to 24 Months   (Child)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00488800
Other Study ID Numbers0887X-102324
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyNot Provided
Study SponsorWyeth is now a wholly owned subsidiary of Pfizer
CollaboratorsNot Provided
Investigators
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateDecember 2007

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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