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

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NCT01128426

Last updated on November 9, 2019
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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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Descriptive Information
Brief TitlePostlicensure Observational Safety Study of 13vPnC Administered to Infants and Toddlers
Official TitlePostlicensure Observational Safety Study of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) Administered in Routine Use to Infants and Toddlers
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study Population60,000 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
ConditionPneumococcal Disease
InterventionOther: No Intervention
No Intervention
Study Groups/Cohorts1
Intervention: Other: No Intervention
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
Actual Enrollment
 (submitted: June 12, 2014)		53902
Original Estimated Enrollment
 (submitted: May 20, 2010)		60000
Actual Study Completion DateJune 2013
Actual Primary Completion DateJune 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study:All
Ages2 Months to 3 Years   (Child)
Accepts Healthy VolunteersYes
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesUnited States
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01128426
Other Study ID Numbers6096A1-4002
B1851044
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsKaiser Permanente
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJune 2014

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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