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

This study has been completed.
Sponsor:
Collaborator:
Kaiser Permanente
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01128426
First received: May 20, 2010
Last updated: June 12, 2014
Last verified: June 2014
  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:

Primary Outcome Measures:
  • Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient [ Time Frame: 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) ] [ Designated as safety issue: Yes ]
    Relative risk for given event=incidence rate(risk window)/incidence rate(self-control window).Relative risk in inpatient health care setting for pre-dose 1 assessed by comparing incidence rate of reported events in inpatient setting/1000 person-months occurring within 30 days after Dose 1(30-day risk window) with self-control period occurring during 30 days before Dose 1(pre-vaccination 30-day self-control window).Relative risk,exact 2-sided 90 percent (%) confidence intervals (CIs) reported. Medically attended events documented retrospectively according to International Classification of Diseases, ninth Revision (ICD-9) coding.Medical attended event acute bronchiolitis due to Respiratory Syncytial Virus (RSV) has been represented as acute bronchiolitis due to RSV and acute pyelonephritis without renal medullary necrosis(RMN) lesion has been represented as acute pyelonephritis without RMN lesion in measure categories below.Results reported for events reported in either of the windows.

  • Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department [ Time Frame: 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) ] [ Designated as safety issue: Yes ]
    Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in emergency department health care setting for pre-dose 1 was assessed by comparing the incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with self-control period occurring during 30 days before Dose 1 (pre-vaccination 30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.

  • 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 [ Time Frame: 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) ] [ Designated as safety issue: Yes ]
    Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient and emergency department health care setting for pre-dose 1 was assessed by comparing the overall incidence rates of reported events in both settings per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with self-control period occurring during 30 days before Dose 1 (pre-vaccination 30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.

  • Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient [ Time Frame: 30 days after Dose 1 (risk window for Dose 1), 30 days after risk window (post-dose self-control window for Dose 1) ] [ Designated as safety issue: Yes ]
    Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient health care setting for Dose 1 was assessed by comparing the incidence rate of reported events in inpatient setting per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% (CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.

  • Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department [ Time Frame: 30 days after Dose 1 (risk window for Dose 1), 30 days after risk window (post-dose self-control window for Dose 1) ] [ Designated as safety issue: Yes ]
    Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in emergency department health care setting for Dose 1 was assessed by comparing the incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.

  • Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined [ Time Frame: 30 days after Dose 1 (risk window for Dose 1), 30 days after risk window (post-dose self-control window for Dose 1) ] [ Designated as safety issue: Yes ]
    Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient and emergency department health care setting for Dose 1 was assessed by comparing the overall incidence rates of reported events in both settings per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.

  • Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient [ Time Frame: 30 days after Dose 2 (risk window for Dose 2), 30 days after risk window (post-dose self-control window for Dose 2) ] [ Designated as safety issue: Yes ]
    Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient health care setting for Dose 2 was assessed by comparing the incidence rate of reported events in inpatient setting per 1000 person-months occurring within 30 days after Dose 2 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.

  • Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department [ Time Frame: 30 days after Dose 2 (risk window for Dose 2), 30 days after risk window (post-dose self-control window for Dose 2) ] [ Designated as safety issue: Yes ]
    Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in emergency department health care setting for Dose 2 was assessed by comparing the incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 2 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.

  • Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined [ Time Frame: 30 days after Dose 2 (risk window for Dose 2), 30 days after risk window (post-dose self-control window for Dose 2) ] [ Designated as safety issue: Yes ]
    Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient and emergency department health care setting for Dose 2 was assessed by comparing the overall incidence rates of reported events in both settings per 1000 person-months occurring within 30 days after Dose 2 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results reported for events reported in either of the windows.

  • Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient [ Time Frame: 30 days after Dose 3 (risk window for Dose 3), 30 days after risk window (post-dose self-control window for Dose 3) ] [ Designated as safety issue: Yes ]
    Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient health care setting for Dose 3 was assessed by comparing the incidence rate of reported events in inpatient setting per 1000 person-months occurring within 30 days after Dose 3 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.

  • Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department [ Time Frame: 30 days after Dose 3 (risk window for Dose 3), 30 days after risk window (post-dose self-control window for Dose 3) ] [ Designated as safety issue: Yes ]
    Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in emergency department health care setting for Dose 3 was assessed by comparing the incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 3 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and its corresponding exact 2-sided 90% confidence CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.

  • Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined [ Time Frame: 30 days after Dose 3 (risk window for Dose 3), 30 days after risk window (post-dose self-control window for Dose 3) ] [ Designated as safety issue: Yes ]
    Relative risk for given event=incidence rate(risk window)/incidence rate(self-control window). Relative risk in inpatient and emergency department health care setting for Dose 3 was assessed by comparing the overall incidence rates of reported events in both settings per 1000 person-months occurring within 30 days after Dose 3 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results reported for events reported in either of the windows.

  • Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient [ Time Frame: 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) ] [ Designated as safety issue: Yes ]
    Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). For primary series (Dose 1, 2, 3 combined), all 30-day risk windows and all post-dose 30-day control windows were summed. Relative risk in inpatient health care setting for primary series was assessed by comparing the combined incidence rate of reported events in inpatient setting per 1000 person-months occurring within 30 days after Dose 1, 2, and 3 (risk window) with the combined self-control period occurring during the subsequent 30 days for each dose (self-control windows after risk window for each dose). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.

  • Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department [ Time Frame: 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) ] [ Designated as safety issue: Yes ]
    Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). For primary series (Dose 1, 2, 3 combined), all 30-day risk windows and all post-dose 30-day control windows were summed. Relative risk in emergency department health care setting for primary series was assessed by comparing the combined incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 1, 2, and 3 (risk window) with the combined self-control period occurring during the subsequent 30 days for each dose (self-control windows after risk window for each dose). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.

  • Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined [ Time Frame: 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) ] [ Designated as safety issue: Yes ]
    Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). For primary series (Dose 1, 2, 3 combined), all 30-day risk windows and all post-dose 30-day control windows were summed. Relative risk in in inpatient and emergency department health care setting for primary series was assessed by comparing the combined incidence rate of reported events in both the settings per 1000 person-months occurring within 30 days after Dose 1, 2, and 3 (risk window) with the combined self-control period occurring during the subsequent 30 days for each dose (self-control windows after risk window for each dose). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.


Enrollment: 53902
Study Start Date: June 2010
Study Completion Date: June 2013
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01128426

Locations
United States, California
Northern California Kaiser Permanente
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
Results First Received: May 14, 2014
Last Updated: June 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Pneumococcal conjugate vaccine

ClinicalTrials.gov processed this record on September 16, 2014