Clinical trial NCT01128426: Postlicensure Observational Safety Study of 13vPnC Administered to Infants and Toddlers
Official title: Postlicensure Observational Safety Study of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) Administered in Routine Use to Infants and Toddlers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumococcal Disease
Keywords: Pneumococcal conjugate vaccine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Kaiser Permanente
First posted: 2010-05-21
Enrollment: 53902
Sex: ALL
Minimum age (years): 2
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

Brief summary: 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.


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.

Primary outcomes:
measure: Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
timeFrame: 30 days before Dose 1 (-34 to -5 days before Dose 1, pre-vaccination self-control window for Dose 1), 30 days after Dose 1 (risk window for Dose 1)
measure: Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
timeFrame: 30 days before Dose 1 (-34 to -5 days before Dose 1, pre-vaccination self-control window for Dose 1), 30 days after Dose 1 (risk window for Dose 1)
measure: Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
timeFrame: 30 days before Dose 1 (-34 to -5 days before Dose 1, pre-vaccination self-control window for Dose 1), 30 days after Dose 1 (risk window for Dose 1)
measure: Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
timeFrame: 30 days after Dose 1 (risk window for Dose 1), 30 days after risk window (post-dose self-control window for Dose 1)
measure: Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
timeFrame: 30 days after Dose 1 (risk window for Dose 1), 30 days after risk window (post-dose self-control window for Dose 1)
measure: Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
timeFrame: 30 days after Dose 1 (risk window for Dose 1), 30 days after risk window (post-dose self-control window for Dose 1)
measure: Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
timeFrame: 30 days after Dose 2 (risk window for Dose 2), 30 days after risk window (post-dose self-control window for Dose 2)
measure: Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
timeFrame: 30 days after Dose 2 (risk window for Dose 2), 30 days after risk window (post-dose self-control window for Dose 2)
measure: Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
timeFrame: 30 days after Dose 2 (risk window for Dose 2), 30 days after risk window (post-dose self-control window for Dose 2)
measure: Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
timeFrame: 30 days after Dose 3 (risk window for Dose 3), 30 days after risk window (post-dose self-control window for Dose 3)
measure: Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
timeFrame: 30 days after Dose 3 (risk window for Dose 3), 30 days after risk window (post-dose self-control window for Dose 3)
measure: Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
timeFrame: 30 days after Dose 3 (risk window for Dose 3), 30 days after risk window (post-dose self-control window for Dose 3)
measure: Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
timeFrame: 30 days after Dose 1, 2, 3 combined (risk window for primary series), 30 days after risk window for Dose 1, 2, 3 combined (post-dose self-control window for primary series)
measure: Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
timeFrame: 30 days after Dose 1, 2, 3 combined (risk window for primary series), 30 days after risk window for Dose 1, 2, 3 combined (post-dose self-control window for primary series)
measure: Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
timeFrame: 30 days after Dose 1, 2, 3 combined (risk window for primary series), 30 days after risk window for Dose 1, 2, 3 combined (post-dose self-control window for primary series)
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Northern California Kaiser Permanente
state: California
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: