Trial Outcomes & Findings for Post Market Surveillance to Observe Safety of Prevenar13™ in Adults (NCT NCT01834222)

NCT ID: NCT01834222

Last Updated: 2017-04-18

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 659 participants
• Primary outcome timeframe: Baseline (Day 1) up to Day 29
• Results posted on: 2017-04-18

Participant Flow

Participant milestones

Measure	Prevenar 13 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.
Overall Study STARTED	659
Overall Study Treated	658
Overall Study COMPLETED	658
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Prevenar 13 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.
Overall Study Not meet inclusion/exclusion criteria	1

Baseline Characteristics

Post Market Surveillance to Observe Safety of Prevenar13™ in Adults

Baseline characteristics by cohort

Measure	Prevenar 13 n=658 Participants 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.
Age, Continuous	58.81 years STANDARD_DEVIATION 11.53 • n=5 Participants
Sex: Female, Male Female	337 Participants n=5 Participants
Sex: Female, Male Male	321 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) up to Day 29

Population: Safety analysis set included all participants who received at least 1 dose of Prevenar 13.

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.

Outcome measures

Measure	Prevenar 13 n=658 Participants 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.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	140 participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	2 participants

PRIMARY outcome

Timeframe: Baseline (Day 1) up to Day 29

Population: Safety analysis set included all participants who received at least 1 dose of Prevenar 13.

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.

Outcome measures

Measure	Prevenar 13 n=658 Participants 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.
Duration of Adverse Events (AEs)	4.89 days Standard Deviation 7.22

PRIMARY outcome

Timeframe: Baseline (Day 1) up to Day 29

Population: Safety analysis set included all participants who received at least 1 dose of Prevenar 13.

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.

Outcome measures

Measure	Prevenar 13 n=658 Participants 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.
Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity Mild	127 participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity Moderate	17 participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity Severe	2 participants

PRIMARY outcome

Timeframe: Baseline (Day 1) up to Day 29

Population: 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.

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.

Outcome measures

Measure	Prevenar 13 n=140 Participants 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.
Number of Participants With Outcome in Response to Adverse Events (AEs) No (Resolved)	132 participants
Number of Participants With Outcome in Response to Adverse Events (AEs) Yes	3 participants
Number of Participants With Outcome in Response to Adverse Events (AEs) Unknown	5 participants

PRIMARY outcome

Timeframe: Baseline (Day 1) up to Day 29

Population: 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.

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

Outcome measures

Measure	Prevenar 13 n=140 Participants 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.
Number of Participants Who Discontinued Due to Adverse Events (AEs)	0 participants

PRIMARY outcome

Timeframe: Baseline (Day 1) up to Day 29

Population: 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.

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.

Outcome measures

Measure	Prevenar 13 n=140 Participants 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.
Percentage of Adverse Events (AEs) With Their Causal Relationship to Study Drug Certain	47.60 percentage of adverse events
Percentage of Adverse Events (AEs) With Their Causal Relationship to Study Drug Probable	24.04 percentage of adverse events
Percentage of Adverse Events (AEs) With Their Causal Relationship to Study Drug Possible	20.67 percentage of adverse events
Percentage of Adverse Events (AEs) With Their Causal Relationship to Study Drug Unlikely	7.69 percentage of adverse events

Adverse Events

Prevenar 13

Serious events: 2 serious events

Other events: 139 other events

Deaths: 0 deaths

Serious adverse events

Measure	Prevenar 13 n=658 participants at risk 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.
Gastrointestinal disorders INTESTINAL OBSTRUCTION	0.15% 1/658 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.
Gastrointestinal disorders VOMITING	0.15% 1/658 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.
Infections and infestations INFECTION VIRAL	0.15% 1/658 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.

Other adverse events

Measure	Prevenar 13 n=658 participants at risk 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.
Infections and infestations CELLULITIS	0.76% 5/658 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.
General disorders INJECTION SITE PAIN	12.0% 79/658 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.
General disorders INJECTION SITE PRURITUS	1.8% 12/658 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.
General disorders INJECTION SITE REACTION	5.3% 35/658 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.
General disorders INJECTION SITE URTICARIA	0.15% 1/658 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.
General disorders ALLERGIC REACTION	0.15% 1/658 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.
Investigations C-REACTIVE PROTEIN INCREASED	0.15% 1/658 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.
General disorders FEVER	3.8% 25/658 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.
General disorders RIGORS	0.30% 2/658 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.
Nervous system disorders MIGRAINE	0.15% 1/658 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.
Gastrointestinal disorders DYSPEPSIA	0.15% 1/658 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.
Gastrointestinal disorders GASTRIC ULCER	0.15% 1/658 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.
Gastrointestinal disorders GASTROENTERITIS	0.15% 1/658 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.
Musculoskeletal and connective tissue disorders BACK PAIN	0.15% 1/658 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.
Musculoskeletal and connective tissue disorders MYALGIA	3.2% 21/658 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.
Infections and infestations HERPES ZOSTER	0.15% 1/658 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.
Infections and infestations PHARYNGITIS	0.15% 1/658 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.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	0.15% 1/658 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.
Infections and infestations URINARY TRACT INFECTION	0.15% 1/658 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.
Respiratory, thoracic and mediastinal disorders COUGHING	0.30% 2/658 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.
Skin and subcutaneous tissue disorders URTICARIA	0.15% 1/658 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.
Blood and lymphatic system disorders LEUCOPENIA	0.15% 1/658 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.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 001-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER