NCT03014206

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

Completed Results posted Last updated 13 September 2023

What this trial tests

trial in Adult Not Younger Than 65 Years in 696 participants. Completed in 31 January 2017.

Timeline

15 June 2015

Primary endpoint
31 January 2017

31 January 2017

Quick facts

Lead sponsor	Pfizer
Status	Completed
Study type	OBSERVATIONAL
Enrollment	696
Start date	15 June 2015
Primary completion	31 January 2017
Estimated completion	31 January 2017
Sites	1 location across Japan

Conditions studied

• Adult Not Younger Than 65 Years — all drugs for Adult Not Younger Than 65 Years →

Sponsor

Pfizer — full company profile →

Who can join

65 and older, any sex, with Adult Not Younger Than 65 Years. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Adverse Reactions Primary · 28 days

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.

Adverse Reactions

Group	Value	95% CI
Prevenar 13 (Pneumococcal 13-valent Conjugate Vaccine)	80

Serious Adverse Reactions

Group	Value	95% CI
Prevenar 13 (Pneumococcal 13-valent Conjugate Vaccine)	1

Adverse events — posted to ClinicalTrials.gov

Time frame: 28 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Prevenar 13 (Pneumococcal 13-valent Conjugate Vaccine)

Serious: 6/684 (1%)

Deaths: 0/684

Serious adverse events (6 terms)

Reaction	System	Prevenar 13 (Pneumococcal …
Pneumonia	Infections and infestations	—
Vaccination site cellulitis	Infections and infestations	—
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Aspiration	Respiratory, thoracic and mediastinal disorders	—
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—

Other adverse events (14 terms — click to expand)

Reaction	System	Prevenar 13 (Pneumococcal …
Vaccination site swelling	General disorders	—
Vaccination site erythema	General disorders	—
Vaccination site pain	General disorders	—
Pyrexia	General disorders	—
Vaccination site pruritus	General disorders	—
Malaise	General disorders	—
Nausea	Gastrointestinal disorders	—
Injection site hypoaesthesia	General disorders	—
Pneumonia	Infections and infestations	—
Urinary tract infection	Infections and infestations	—
Vaccination complication	Injury, poisoning and procedural complications	—
Blood creatine phosphokinase increased	Investigations	—
Rash generalised	Skin and subcutaneous tissue disorders	—
Vaccination site dermatitis	General disorders	—

Most-reported serious reactions: Pneumonia, Vaccination site cellulitis, Bladder cancer, Aspiration, Chronic obstructive pulmonary disease, Respiratory failure.

Data from ClinicalTrials.gov NCT03014206 adverse events section.

Sponsor's own description

This study aims to understand the following items in post-marketing actual clinical settings to evaluate the safety of 13vPnC administered as a single dose in the elderly (adults aged 65 years or older).

1. To confirm the use in actual clinical settings
2. To confirm the occurrence of adverse events

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.