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Postlicensure Observational Safety Study of 13vPnC Administered to Infants and Toddlers

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NCT01128426

Last updated on April 11, 2018
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FOR MORE INFORMATION
Study Location
Northern California Kaiser Permanente
Oakland, California, 94612 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
2-3 months
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Infants starting vaccination with 13vPnC in the first 6 months of life who are members
of the Northern California Kaiser Permanente healthcase system and who receive at
least 1 dose of 13vPnC during the study observation period will be included. Infants
must not have had 7vPnC at the time of 13vPnC dose administration.

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

- Infants and children who were previously vaccinated with any number of doses of 7vPnC
will be excluded.

NCT01128426
Pfizer
Completed
Postlicensure Observational Safety Study of 13vPnC Administered to Infants and Toddlers

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Postlicensure Observational Safety Study of 13vPnC Administered to Infants and Toddlers
Postlicensure Observational Safety Study of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) Administered in Routine Use to Infants and Toddlers
The purpose of the study is to expand the understanding of the safety profile of 13vPnC in routine use following licensure and introduction of the vaccine.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
60,000 infants total: at least 43,000 infants who receive all 3 primary series doses of 13vPnC plus 15,000 additional infants who receive less than 3 doses of 13vPnC
Pneumococcal Disease
Other: No Intervention
No Intervention
1
Intervention: Other: No Intervention
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53902
June 2013
June 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Infants starting vaccination with 13vPnC in the first 6 months of life who are members of the Northern California Kaiser Permanente healthcase system and who receive at least 1 dose of 13vPnC during the study observation period will be included. Infants must not have had 7vPnC at the time of 13vPnC dose administration.

Exclusion Criteria:

  • Infants and children who were previously vaccinated with any number of doses of 7vPnC will be excluded.
Sexes Eligible for Study: All
2 Months to 3 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01128426
6096A1-4002
B1851044
No
Not Provided
Not Provided
Pfizer
Pfizer
Kaiser Permanente
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2014

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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1-800-718-1021

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[email protected]



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