Postlicensure Observational Safety Study of 13vPnC Administered to Infants and Toddlers
This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Pfizer
Collaborator:
Kaiser Permanente
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01128426
First received: May 20, 2010
Last updated: May 14, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pneumococcal Disease |
Other: No Intervention |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Postlicensure Observational Safety Study of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) Administered in Routine Use to Infants and Toddlers |
Further study details as provided by Pfizer:
| Estimated Enrollment: | 60000 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| 1 |
Other: No Intervention
No Intervention
|
Eligibility| Ages Eligible for Study: | 2 Months to 3 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
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
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01128426
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Locations
| United States, California | |
| Northern California Kaiser Permanente | Recruiting |
| Oakland, California, United States, 94612 | |
Sponsors and Collaborators
Pfizer
Kaiser Permanente
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01128426 History of Changes |
| Other Study ID Numbers: | 6096A1-4002, B1851044 |
| Study First Received: | May 20, 2010 |
| Last Updated: | May 14, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Pneumococcal conjugate vaccine |
ClinicalTrials.gov processed this record on May 19, 2013