Post Market Surveillance to Observe Safety of Prevenar13™ in Adults

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT01834222
Collaborator
(none)
659
27
27
24.4
0.9

Study Details

Study Description

Brief Summary

The purpose of this study is to assess safety profile of Prevenar 13™ when used among Korean adults in the routine clinical setting, as required for any new drug approved by Korea Food and Drug Administration (KFDA).

Condition or Disease Intervention/Treatment Phase
  • Biological: Non-intervention

Detailed Description

non-randomization, non-probability sampling

Study Design

Study Type:
Observational
Actual Enrollment :
659 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Post Marketing Surveillance To Observe Safety Of Prevenar 13 In Adults
Study Start Date :
Dec 1, 2013
Actual Primary Completion Date :
Mar 1, 2016
Actual Study Completion Date :
Mar 1, 2016

Arms and Interventions

Arm Intervention/Treatment
1

Korean adults aged 50 years and older who receive Prevenar13™ in a routine clinical setting

Biological: Non-intervention
Non-intervention

Outcome Measures

Primary Outcome Measures

  1. Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Baseline (Day 1) up to Day 29]

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose (up to Day 29) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AE.

  2. Duration of Adverse Events (AEs) [Baseline (Day 1) up to Day 29]

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Duration of adverse event (in days) was defined as total time from onset of adverse event till the event was resolved during study.

  3. Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity [Baseline (Day 1) up to Day 29]

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed on basis of severity as follows: a) mild: did not caused any significant problem to the participant; b) moderate: caused problem that did not interfere significantly with usual activities or the clinical status, other therapy needed due to AE; c) severe: caused problem that interfered significantly with usual activities or the clinical status.

  4. Number of Participants With Outcome in Response to Adverse Events (AEs) [Baseline (Day 1) up to Day 29]

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was assessed among participants based on their response to a question 'Is the adverse event still present?' as 'yes', 'unknown' or 'no (resolved)' during study.

  5. Number of Participants Who Discontinued Due to Adverse Events (AEs) [Baseline (Day 1) up to Day 29]

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

  6. Percentage of Adverse Events (AEs) With Their Causal Relationship to Study Drug [Baseline (Day 1) up to Day 29]

    Criteria: a)Certain: followed a reasonable time sequence from administration of drug; unexplained by other drugs, chemical substance or accompanying diseases;had clinically reasonable reaction on cessation of drug; had pharmacological or phenomenological reaction to re-administration of drug, b)Probable: followed a reasonable time sequence from administration of the drug; unexplained by other drugs;chemical substance or accompanying diseases; had clinically reasonable reaction on cessation of the drug, c)Possible:followed a reasonable time sequence from administration of drug; can also be explained by other drugs;chemical substance or accompanying diseases; lacks information or had unclear information on discontinuation of drug, d)Unlikely:not likely to had a reasonable causal relationship from administration of drug; seemed temporary; can also be reasonably explained by other drugs; chemical substances or latent diseases; conditional (need more data for true assessment),unaccessible.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Korean adults aged 18 years and older; provided the conditions pertaining to contraindications, warnings, precautions, and interactions stated in the local product document do not apply.

  • Evidence of a personally signed and dated informed consent document indicating that the subject(or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Exclusion Criteria:

Subjects who are not indicated and/or contraindicated for the Prevenar13 usage will not be included.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chungnam National University Hospital (CNUH) Jung-gu Daejeon Korea, Republic of 35015
2 Bundang 21st Clinic Seongnam Gyeonggi-do Korea, Republic of 463-823
3 Lee soo yang Internal Medical Clinic Guro-gu Seoul Korea, Republic of 152-893
4 Hansarang Internal Medicine Hospital Busan South Korea Korea, Republic of 616-820
5 Shin Clinic Internal Medicine Seoul South Korea Korea, Republic of 135-830
6 Pusan National University Hospital Busan Korea, Republic of 49241
7 Pusan National University Hospital Busan Korea, Republic of 602-739
8 Keimyung University Dongsan Hospital Daegu Korea, Republic of 41931
9 Samsung Happy Clinic Daejeon Korea, Republic of 300-826
10 Chungnam National University Hospital Daejeon Korea, Republic of 301-721
11 Pusan National Univeristy Hospital Daejeon Korea, Republic of 301-812
12 MiSo Medical Daejeon Korea, Republic of 302-120
13 Sun's internal medicine Daejeon Korea, Republic of 305-509
14 Techno Internal Medicine Clinic Daejeon Korea, Republic of 305-509
15 Chuncheon Sacred Heart Hospital-Hallym University Gangwon-do Korea, Republic of 24253
16 Dr. Lee's Medical Clinic GwangJu Korea, Republic of 501-190
17 Chonnam National University Hospital Gwangju Korea, Republic of 501-757
18 Chonnam National University Hospital Gwangju Korea, Republic of 61469
19 Suh Jeong Min Clinic Gyeonggi-do Korea, Republic of 441-885
20 Bundang 21st Clinic Gyeonggi-do Korea, Republic of 463-823
21 Light & Salt Internal Medicine Gyeonggi-do Korea, Republic of
22 Seoul Samsung Medical Clinic Seoul Korea, Republic of 122-823
23 Dr. Lee's Clinic of Internal Medicine Seoul Korea, Republic of 139-716
24 Sung's Medical Clinic Seoul Korea, Republic of 153-806
25 GF Internal Medicine Seoul Korea, Republic of
26 Jong Koo Lee Heart Clinic Seoul Korea, Republic of
27 Ulsan University Hospital Ulsan Korea, Republic of 682-714

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT01834222
Other Study ID Numbers:
  • B1851143
First Posted:
Apr 17, 2013
Last Update Posted:
Apr 18, 2017
Last Verified:
Mar 1, 2017
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Prevenar 13
Arm/Group Description Participants received single dose of Prevenar 13 vaccine, 0.5 milliliter (mL) intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination.
Period Title: Overall Study
STARTED 659
Treated 658
COMPLETED 658
NOT COMPLETED 1

Baseline Characteristics

Arm/Group Title Prevenar 13
Arm/Group Description Participants received single dose of Prevenar 13 vaccine, 0.5 mL intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination.
Overall Participants 658
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
58.81
(11.53)
Sex: Female, Male (Count of Participants)
Female
337
51.2%
Male
321
48.8%

Outcome Measures

1. Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose (up to Day 29) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AE.
Time Frame Baseline (Day 1) up to Day 29

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of Prevenar 13.
Arm/Group Title Prevenar 13
Arm/Group Description Participants received single dose of Prevenar 13 vaccine, 0.5 mL intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination.
Measure Participants 658
AEs
140
21.3%
SAEs
2
0.3%
2. Primary Outcome
Title Duration of Adverse Events (AEs)
Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Duration of adverse event (in days) was defined as total time from onset of adverse event till the event was resolved during study.
Time Frame Baseline (Day 1) up to Day 29

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of Prevenar 13.
Arm/Group Title Prevenar 13
Arm/Group Description Participants received single dose of Prevenar 13 vaccine, 0.5 mL intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination.
Measure Participants 658
Mean (Standard Deviation) [days]
4.89
(7.22)
3. Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity
Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed on basis of severity as follows: a) mild: did not caused any significant problem to the participant; b) moderate: caused problem that did not interfere significantly with usual activities or the clinical status, other therapy needed due to AE; c) severe: caused problem that interfered significantly with usual activities or the clinical status.
Time Frame Baseline (Day 1) up to Day 29

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of Prevenar 13.
Arm/Group Title Prevenar 13
Arm/Group Description Participants received single dose of Prevenar 13 vaccine, 0.5 mL intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination.
Measure Participants 658
Mild
127
19.3%
Moderate
17
2.6%
Severe
2
0.3%
4. Primary Outcome
Title Number of Participants With Outcome in Response to Adverse Events (AEs)
Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was assessed among participants based on their response to a question 'Is the adverse event still present?' as 'yes', 'unknown' or 'no (resolved)' during study.
Time Frame Baseline (Day 1) up to Day 29

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of Prevenar 13. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Prevenar 13
Arm/Group Description Participants received single dose of Prevenar 13 vaccine, 0.5 mL intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination.
Measure Participants 140
No (Resolved)
132
20.1%
Yes
3
0.5%
Unknown
5
0.8%
5. Primary Outcome
Title Number of Participants Who Discontinued Due to Adverse Events (AEs)
Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Time Frame Baseline (Day 1) up to Day 29

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of Prevenar 13. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Prevenar 13
Arm/Group Description Participants received single dose of Prevenar 13 vaccine, 0.5 mL intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination.
Measure Participants 140
Number [participants]
0
0%
6. Primary Outcome
Title Percentage of Adverse Events (AEs) With Their Causal Relationship to Study Drug
Description Criteria: a)Certain: followed a reasonable time sequence from administration of drug; unexplained by other drugs, chemical substance or accompanying diseases;had clinically reasonable reaction on cessation of drug; had pharmacological or phenomenological reaction to re-administration of drug, b)Probable: followed a reasonable time sequence from administration of the drug; unexplained by other drugs;chemical substance or accompanying diseases; had clinically reasonable reaction on cessation of the drug, c)Possible:followed a reasonable time sequence from administration of drug; can also be explained by other drugs;chemical substance or accompanying diseases; lacks information or had unclear information on discontinuation of drug, d)Unlikely:not likely to had a reasonable causal relationship from administration of drug; seemed temporary; can also be reasonably explained by other drugs; chemical substances or latent diseases; conditional (need more data for true assessment),unaccessible.
Time Frame Baseline (Day 1) up to Day 29

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of Prevenar 13. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Arm/Group Title Prevenar 13
Arm/Group Description Participants received single dose of Prevenar 13 vaccine, 0.5 mL intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination.
Measure Participants 140
Certain
47.60
Probable
24.04
Possible
20.67
Unlikely
7.69

Adverse Events

Time Frame
Adverse Event Reporting Description The same event may appear as both AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experience both a serious and non-serious event during the study. Analysis was performed on safety analysis set.
Arm/Group Title Prevenar 13
Arm/Group Description Participants received single dose of Prevenar 13 vaccine, 0.5 mL intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination.
All Cause Mortality
Prevenar 13
Affected / at Risk (%) # Events
Total / (NaN)
Serious Adverse Events
Prevenar 13
Affected / at Risk (%) # Events
Total 2/658 (0.3%)
Gastrointestinal disorders
INTESTINAL OBSTRUCTION 1/658 (0.2%)
VOMITING 1/658 (0.2%)
Infections and infestations
INFECTION VIRAL 1/658 (0.2%)
Other (Not Including Serious) Adverse Events
Prevenar 13
Affected / at Risk (%) # Events
Total 139/658 (21.1%)
Blood and lymphatic system disorders
LEUCOPENIA 1/658 (0.2%)
Gastrointestinal disorders
DYSPEPSIA 1/658 (0.2%)
GASTRIC ULCER 1/658 (0.2%)
GASTROENTERITIS 1/658 (0.2%)
General disorders
INJECTION SITE PAIN 79/658 (12%)
INJECTION SITE PRURITUS 12/658 (1.8%)
INJECTION SITE REACTION 35/658 (5.3%)
INJECTION SITE URTICARIA 1/658 (0.2%)
ALLERGIC REACTION 1/658 (0.2%)
FEVER 25/658 (3.8%)
RIGORS 2/658 (0.3%)
Infections and infestations
CELLULITIS 5/658 (0.8%)
HERPES ZOSTER 1/658 (0.2%)
PHARYNGITIS 1/658 (0.2%)
UPPER RESPIRATORY TRACT INFECTION 1/658 (0.2%)
URINARY TRACT INFECTION 1/658 (0.2%)
Investigations
C-REACTIVE PROTEIN INCREASED 1/658 (0.2%)
Musculoskeletal and connective tissue disorders
BACK PAIN 1/658 (0.2%)
MYALGIA 21/658 (3.2%)
Nervous system disorders
MIGRAINE 1/658 (0.2%)
Respiratory, thoracic and mediastinal disorders
COUGHING 2/658 (0.3%)
Skin and subcutaneous tissue disorders
URTICARIA 1/658 (0.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Results Point of Contact

Name/Title Pfizer ClinicalTrials.gov Call Center
Organization Pfizer, Inc.
Phone 001-800-718-1021
Email ClinicalTrials.gov_Inquiries@pfizer.com
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT01834222
Other Study ID Numbers:
  • B1851143
First Posted:
Apr 17, 2013
Last Update Posted:
Apr 18, 2017
Last Verified:
Mar 1, 2017