Pneumococcal DiseaseNCT01396434

Safety Surveillance of Pneumococcal 13-valent Conjugate Vaccine Among Filipinos

An observational study of Pneumococcal Disease, run by Pfizer at 119 sites in Philippines.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Prevenar 13 is safe for administration to Filipinos. Read more about this study

Who is it for?: Ages 6 weeks and olderHealthy volunteers can take part
Conditions the study is for: Pneumococcal Disease
What is being tested?: Prevenar 13
Type of treatment: Vaccines
How many people: 3,006 participants
Where: 119 sitesPhilippines
Study dates: Dec 2011to May 2014
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 weeks and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Study population: Filipino patients prescribed with the vaccine

Who may be able to join

Patients prescribed with the vaccine

Who cannot join

Patients with hypersensitivity to the vaccine

Trial locations and contacts

119 sites in 1 country.

City, postcode or hospital

119 sites in 1 country

Philippines119 sites

Private Clinic
Angeles City
Private Clinic
Antipolo City
Room 220 The Doctor's Hospital, Inc.
Bacolod City, Negros Occidental
Dr. Pablo O. Torre Memorial Medical Center
Bacolod City, 6100
Medical Arts Building
Bacolod City
Medical Plaza
Bacolod City
Private Clinic
Bacolod City
Riverside Medical Center
Bacolod City
Room 302 Medical Arts Building
Bacolod City
Room 311 Riverside Medical Arts Building
Bacolod City
Villanueva Laboratory and Clinics
Bacolod City
MCA Bauanan Children's Clinic
Batangas
Private Clinic
Batangas
Metropolitan Medical Center
Binondo, Manila
Private Clinic
Bocaue
417
Bulacan
Clinica Tapia
Bulacan
Pediatric Doctor's Clinic
Bulacan
Private Clinic
Bulacan
St Vincent's Wellness Clinic
Bulacan
Room 11
Cagayan de Oro
Centralle Medical Diagnostics and Polyclinic
Caloocan
Private Clinic
Caloocan
Private Clinic
Candelaria
Blk 19 Lot 11
Capiz
Private Clinic
Cavite
Cebu Doctor University Hospital
Cebu, Cebu, 6000
Chong Hua Hospital
Cebu, 6000
Chong Hua Hospital
Cebu
Basement
Cebu City
Care and Cure Hub
Cebu City
Cebu Doctors University Hopsital
Cebu City
Chong Hua Hospital
Cebu City
PPG, Manila, Philippines
Cebu City
Private Clinic
Cebu City
Rm4A, Medical Arts Building
Cebu City
Room 302-A
Cebu City
Room 413 Medical Arts Building 2
Cebu City
Room 419 SPC Medical Specialty Center
Cebu City
Room 505A Chong Hua Medical Arts Building
Cebu City
Private Clinic
Dagupan, Pangasinan
Private Clinic
Dagupan
Community Health and Development Cooperative Hospital
Davao City
Health Science and Wellness Center
Davao City
Jesusa Complex
Davao City
Private Clinic
Davao City
San Pedro Hospital Inc.
Davao City
San Pedro Hospital
Davao City
Private Clinic
Dipolog City
Private Clinic
Dumaguete
Room 117 Medical Arts Building
Dumaguete
Iligan Specialist Clinic
Iligan City
Private Clinic
Iloilo City
Private Clinic
Koronadal
Private Clinic
Laguna
Las Pinas Doctors Hospital
Las Piñas
Private Clinic
Legaspi
Private Clinic
Lipa City, Batangas
Private Clinic
Lipa City
Lucena United Doctors Hospital
Lucena City
Private Clinic
Lucena City
Private Clinic
Makati City
Archangel Raphael Pediatric Clinic
Malabon
Children's Clinic
Malabon
Malabon Medical Clinic
Malabon
Tumbicon Polycare
Malabon
Private Clinic
Malolos, Bulacan
Private Clinic
Malolos
Private Clinic
Mandaluyong
Private Clinic
Mangaldan, Pangasinan
Metropolitan Medical Center
Manila, 1000
1952
Manila
Children's Clinic
Manila
Chinese General Hospital
Manila
Private Clinic
Manila
Rm714B
Manila
Room 210, Metropolitan Medical Center
Manila
Room 706
Manila
Marikina Valley Medical Center
Marikina City, 1801
Centro Medical and Laboratory Clinic
Marikina City
Garcia General Hospital
Marikina City
Private Clinic
Marikina City
Room 605
Marikina City
Private Clinic
Negors Occidental
Private Clinic
Negros Occidental
Mabalacat Child Care Clinic
Pampanga
Private Clinic
Pangasinan
Maglana Villamor Clinic
Paranaque City
Paranaque Doctors Hospital
Paranaque City
Private Clinic
Pasig
Private Clinic
Pozorrubio, Pangasinan
Emil-Joanna General Hospital
Quezon
Private Clinic
Quezon
Philippine Heart Center
Quezon City, 1100
Friendly Care Clinic
Quezon City
Madrid Polyclinic
Quezon City
Maternity and Children's Clinic
Quezon City
Medical Specialist Clinic
Quezon City
Natividad Children's Clinic
Quezon City
Philippine Heart Center
Quezon City
Private Clinic
Quezon City
Room 11
Quezon City
World Citi Medical Center
Quezon City
Children'S Clinic
Rizal
Private Clinic
Rizal
Private Clinic
San Carlos City, Negros Occidental
San Carlos Doctor's Hospital
San Carlos City, Negros Occidental
Community General Hospital
San Pablo
Private Clinic
San Pablo
Chinese General Hospital and Medical Center
Santa Cruz, Manila
Private Clinic
South Luzon
Private Clinic
Tagbilaran City, Bohol
Private Clinic
Tagbilaran City
Private Clinic
Tarlac City
Private Clinic
Urdaneta
Private Clinic
Valenzuela
Victorias Commercial Center
Victorias City, Negros Occidental
Private Clinic
Zamboanga City
Room 331
Zamboanga City

Other trials in Philippines

About this study

Official title: A Non-interventional Study Of The Safety Of Pneumococcal 13-valent Conjugate Vaccine (Prevenar 13) In The Philippines: A Post Marketing Surveillance Study

Prevenar 13 is safe for administration to Filipinos.

Read the detailed description

Filipino patients prescribed and administered with the vaccine will be monitored for safety Patients prescribed with the vaccine who provides consent for inclusion to the study will be observed.

Conditions: Pneumococcal Disease
Being tested: Prevenar 13
Medical subject headings: Pneumococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Prevenar 13Biological
Also called Pneumococcal 13-valent Conjugate Vaccine (13vPnC)
Prevenar 13 vaccine as prescribed by the physician based on approved product indication

Study groups in NCT01396434
Study group	Role	What they receive
Prevenar 13 patients		Not described Receives: Biological: Prevenar 13

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to 13vPnC were reported. An AE was any untoward medical occurrence in a participant who received 13vPnC. 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. AEs included both SAEs and non-SAEs.
Measured: Baseline through and including 28 calendar days after the last administration of study vaccine within the observation period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2011May 2014

First posted18 Jul 2011 (estimated)
Study startDec 2011
Primary completionMay 2014
Study completionMay 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pneumococcal DiseaseStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Time perspective: Prospective
Enrolment: 3,006 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01396434
Sponsor's protocol ID: B1851076
Status last verified: Jan 2016
First submitted: 22 Jun 2011
Last updated: 30 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pneumococcal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Non-interventional Study Of The Safety Of Pneumococcal 13-valent Conjugate Vaccine (Prevenar 13) In The Philippines: A Post Marketing Surveillance Study
ClinicalTrials.gov ID: NCT01396434
Acronym / sponsor ID: B1851076
Conditions: Pneumococcal Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 3,006 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Dec 2011
Primary completion: May 2014 (actual)
Study completion: May 2014 (actual)
First posted: 18 Jul 2011 (estimated)
Results: Posted 30 Jan 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Prevenar 13 is safe for administration to Filipinos.

Detailed description

Filipino patients prescribed and administered with the vaccine will be monitored for safety Patients prescribed with the vaccine who provides consent for inclusion to the study will be observed.

Study design

Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Prevenar 13 patients	–	Biological: Prevenar 13

Who may qualify

Ages: 6 weeks and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult
Study population: Filipino patients prescribed with the vaccine

Key inclusion criteria (1 listed)

Patients prescribed with the vaccine

Key exclusion criteria (1 listed)

Patients with hypersensitivity to the vaccine

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Prevenar 13Also: Pneumococcal 13-valent Conjugate Vaccine (13vPnC)Prevenar 13 vaccine as prescribed by the physician based on approved product indication	Biological	Prevenar 13 patients

Primary outcome

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline through and including 28 calendar days after the last administration of study vaccine within the observation period
All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to 13vPnC were reported. An AE was any untoward medical occurrence in a participant who received 13vPnC. 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. AEs included both SAEs and non-SAEs.

Results and safety

Results posted to the registry on 30 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
13vPnC (Prevenar 13), Cohort 1	2,817	2,806
13vPnC (Prevenar 13), Cohort 2	175	175
13vPnC (Prevenar 13), Cohort 3	14	14

Primary outcome: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: Baseline through and including 28 calendar days after the last administration of study vaccine within the observation period. Number. Unit: participants

Measure	13vPnC (Prevenar 13), Cohort 1 n = 2817	13vPnC (Prevenar 13), Cohort 2 n = 175	13vPnC (Prevenar 13), Cohort 3 n = 14
AEs	68	5	0
SAEs	1	0	0

Population analysed: Participants who received at least 1 dose of 13vPnC.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
13vPnC (Prevenar 13), Cohort 1	1 of 2,817 (0%)	68 of 2,817 (2.4%)	Not reported
13vPnC (Prevenar 13), Cohort 2	0 of 175 (0%)	5 of 175 (2.9%)	Not reported
13vPnC (Prevenar 13), Cohort 3	0 of 14 (0%)	0 of 14 (0%)	Not reported

Limitations and caveats (from the sponsor): The use of 13vPnC was based on the investigator's clinical judgment and was assumed to be consistent with the product's approved label.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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RecruitingPhase 3
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Active, not recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

119 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Pneumococcal Disease, run by Pfizer at 119 sites in Philippines.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 119 sites in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Baseline through and including 28 calendar days after the last administration of study vaccine within the observation period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01396434.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2017.