Trial Outcomes & Findings for Prevenar13 Drug Use Investigation - Adults Aged 65 Years or Older- (NCT NCT03014206)

Last Updated: 2023-09-13

Results Overview

An adverse reaction (vaccine-related adverse event) was any untoward medical occurrence attributed to Prevenar 13 in a participant who received Prevenar 13. A serious adverse reaction was a vaccine-related adverse event 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. Relatedness to Prevenar 13 was assessed by the physician.

Recruitment status

COMPLETED

Target enrollment

696 participants

Primary outcome timeframe

28 days

Results posted on

2023-09-13

Participant Flow

Participant milestones

Participant milestones
Measure	Prevenar 13 (Pneumococcal 13-valent Conjugate Vaccine) Participants who received Prevenar 13 as indicated in the approved local product document were observed for a period of 28 days.
Overall Study STARTED	696
Overall Study COMPLETED	684
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Prevenar 13 (Pneumococcal 13-valent Conjugate Vaccine) Participants who received Prevenar 13 as indicated in the approved local product document were observed for a period of 28 days.
Overall Study Registration Violation	12

Baseline Characteristics

Prevenar13 Drug Use Investigation - Adults Aged 65 Years or Older-

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prevenar 13 (Pneumococcal 13-valent Conjugate Vaccine) n=684 Participants Participants who received Prevenar 13 as indicated in the approved local product document were observed for a period of 28 days.
Age, Customized <65 years	0 Participants n=99 Participants
Age, Customized ≥65 and <70 years	127 Participants n=99 Participants
Age, Customized ≥70 and <75 years	157 Participants n=99 Participants
Age, Customized ≥75 and <80 years	154 Participants n=99 Participants
Age, Customized ≥80 and <85 years	134 Participants n=99 Participants
Age, Customized ≥85 years	112 Participants n=99 Participants
Sex/Gender, Customized Female	385 Participants n=99 Participants
Sex/Gender, Customized Male	299 Participants n=99 Participants
Race/Ethnicity, Customized Asian	684 Participants n=99 Participants

PRIMARY outcome

Timeframe: 28 days

Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and provided the safety data after vaccination with Prevenar 13.

Outcome measures

Outcome measures
Measure	Prevenar 13 (Pneumococcal 13-valent Conjugate Vaccine) n=684 Participants Participants who received Prevenar 13 as indicated in the approved local product document were observed for a period of 28 days.
Number of Participants With Adverse Reactions Adverse Reactions	80 Participants
Number of Participants With Adverse Reactions Serious Adverse Reactions	1 Participants

Adverse Events

Prevenar 13 (Pneumococcal 13-valent Conjugate Vaccine)

Serious events: 6 serious events

Other events: 85 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Prevenar 13 (Pneumococcal 13-valent Conjugate Vaccine) n=684 participants at risk Participants who received Prevenar 13 as indicated in the approved local product document were observed for a period of 28 days.
Infections and infestations Pneumonia	0.15% 1/684 • Number of events 1 • 28 days The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Infections and infestations Vaccination site cellulitis	0.15% 1/684 • Number of events 1 • 28 days The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.15% 1/684 • Number of events 1 • 28 days The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Respiratory, thoracic and mediastinal disorders Aspiration	0.15% 1/684 • Number of events 1 • 28 days The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.15% 1/684 • Number of events 1 • 28 days The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.15% 1/684 • Number of events 1 • 28 days The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.

Other adverse events

Other adverse events
Measure	Prevenar 13 (Pneumococcal 13-valent Conjugate Vaccine) n=684 participants at risk Participants who received Prevenar 13 as indicated in the approved local product document were observed for a period of 28 days.
Gastrointestinal disorders Nausea	0.15% 1/684 • 28 days The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
General disorders Injection site hypoaesthesia	0.15% 1/684 • 28 days The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
General disorders Malaise	0.29% 2/684 • 28 days The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Infections and infestations Pneumonia	0.15% 1/684 • 28 days The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Infections and infestations Urinary tract infection	0.15% 1/684 • 28 days The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Injury, poisoning and procedural complications Vaccination complication	0.15% 1/684 • 28 days The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Investigations Blood creatine phosphokinase increased	0.15% 1/684 • 28 days The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
Skin and subcutaneous tissue disorders Rash generalised	0.15% 1/684 • 28 days The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
General disorders Pyrexia	1.5% 10/684 • 28 days The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
General disorders Vaccination site dermatitis	0.15% 1/684 • 28 days The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
General disorders Vaccination site erythema	5.1% 35/684 • 28 days The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
General disorders Vaccination site pain	5.0% 34/684 • 28 days The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
General disorders Vaccination site pruritus	0.88% 6/684 • 28 days The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
General disorders Vaccination site swelling	5.3% 36/684 • 28 days The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

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Email: [email protected]

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.
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