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

12. juni 2014 opdateret af: Pfizer

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

53902

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Oakland, California, Forenede Stater, 94612
        • Northern California Kaiser Permanente

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

2 måneder til 3 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kun etui
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
1
Andet: Ingen indgriben
Ingen indgriben

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Tidsramme: 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)
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.
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)
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Tidsramme: 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)
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.
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)
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
Tidsramme: 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)
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.
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)
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Tidsramme: 30 days after Dose 1 (risk window for Dose 1), 30 days after risk window (post-dose self-control window for Dose 1)
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.
30 days after Dose 1 (risk window for Dose 1), 30 days after risk window (post-dose self-control window for Dose 1)
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Tidsramme: 30 days after Dose 1 (risk window for Dose 1), 30 days after risk window (post-dose self-control window for Dose 1)
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.
30 days after Dose 1 (risk window for Dose 1), 30 days after risk window (post-dose self-control window for Dose 1)
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Tidsramme: 30 days after Dose 1 (risk window for Dose 1), 30 days after risk window (post-dose self-control window for Dose 1)
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.
30 days after Dose 1 (risk window for Dose 1), 30 days after risk window (post-dose self-control window for Dose 1)
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Tidsramme: 30 days after Dose 2 (risk window for Dose 2), 30 days after risk window (post-dose self-control window for Dose 2)
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.
30 days after Dose 2 (risk window for Dose 2), 30 days after risk window (post-dose self-control window for Dose 2)
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Tidsramme: 30 days after Dose 2 (risk window for Dose 2), 30 days after risk window (post-dose self-control window for Dose 2)
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.
30 days after Dose 2 (risk window for Dose 2), 30 days after risk window (post-dose self-control window for Dose 2)
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Tidsramme: 30 days after Dose 2 (risk window for Dose 2), 30 days after risk window (post-dose self-control window for Dose 2)
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.
30 days after Dose 2 (risk window for Dose 2), 30 days after risk window (post-dose self-control window for Dose 2)
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Tidsramme: 30 days after Dose 3 (risk window for Dose 3), 30 days after risk window (post-dose self-control window for Dose 3)
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.
30 days after Dose 3 (risk window for Dose 3), 30 days after risk window (post-dose self-control window for Dose 3)
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Tidsramme: 30 days after Dose 3 (risk window for Dose 3), 30 days after risk window (post-dose self-control window for Dose 3)
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.
30 days after Dose 3 (risk window for Dose 3), 30 days after risk window (post-dose self-control window for Dose 3)
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Tidsramme: 30 days after Dose 3 (risk window for Dose 3), 30 days after risk window (post-dose self-control window for Dose 3)
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.
30 days after Dose 3 (risk window for Dose 3), 30 days after risk window (post-dose self-control window for Dose 3)
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Tidsramme: 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)
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.
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)
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Tidsramme: 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)
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.
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)
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Tidsramme: 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)
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.
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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer

Samarbejdspartnere

Kaiser Permanente

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2010

Primær færdiggørelse (Faktiske)

1. juni 2013

Studieafslutning (Faktiske)

1. juni 2013

Datoer for studieregistrering

Først indsendt

20. maj 2010

Først indsendt, der opfyldte QC-kriterier

20. maj 2010

Først opslået (Skøn)

21. maj 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

14. juli 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. juni 2014

Sidst verificeret

1. juni 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 6096A1-4002
  • B1851044

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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