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Safety and Local Tolerability of Prevenar in Indian Children

Last updated on April 10, 2018

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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Similar Trials

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.

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Not Provided
Not Provided
Pneumococcal Infections
Biological: pneumococcal conjugate vaccine
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
January 2007
January 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
6 Weeks to 24 Months   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00488800
0887X-102324
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
December 2007

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

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[email protected]



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