Clinical Trials Logo
  1. Home
  2. Pneumococcal Disease
  3. NCT01396434
  4. Details
NCT01396434 Clinical Trial

Safety Surveillance of Pneumococcal 13-valent Conjugate Vaccine Among Filipinos

Pneumococcal Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01396434
Other study ID # B1851076
Secondary ID
Status Completed
Phase Phase 4
First received June 22, 2011
Last updated June 15, 2015
Start date December 2011
Est. completion date May 2014

Study information
Verified date June 2015
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Philippines : Food and Drug Administration
Study type Observational

Clinical Trial Summary

Prevenar 13 is safe for administration to Filipinos.

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.

Recruitment information / eligibility
Status Completed
Enrollment 3006
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Weeks and older
Eligibility Inclusion Criteria:

Patients prescribed with the vaccine

Exclusion Criteria:

Patients with hypersensitivity to the vaccine

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Biological:
• Prevenar 13
Prevenar 13 vaccine as prescribed by the physician based on approved product indication

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

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Philippines, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants reporting adverse events as a measure of safety 2 years Yes
See also
  Status Clinical Trial Phase
Completed NCT04546425 - 20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants Phase 3
Recruiting NCT06044077 - A Clinical Trial to Evaluate the Immunogenicity and Safety of the 23-valent Pneumococcal Polysaccharide Vaccine in Healthy People Phase 3
Completed NCT02146365 - Nasopharyngeal Carriage Study in Healthy Kenyan Toddlers
Completed NCT04525599 - A Study to Assess the Safety, Tolerability and Immunogenicity of ASP3772, a Pneumococcal Vaccine, in Toddlers 12 to 15 Months of Age in Comparison to an Active Comparator Phase 1
Active, not recruiting NCT05512819 - A Study to Describe the Safety and Immunogenicity of 20vPnC in Infants in India and Taiwan Phase 3
Completed NCT04530838 - 20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants Phase 3
Active, not recruiting NCT06026748 - A Phase I Study of XJ103 in Chinese Healthy Subjects Phase 1
Completed NCT04526574 - Safety and Immunogenicity of 20vPnC Coadministered With SIIV in Adults ≥65 Years of Age Phase 3
Completed NCT05329259 - A Study to Describe the Safety of a Vaccine (Called 13vPnC) in Healthy People 18 to 49 Years of Age in India Phase 4
Completed NCT00234338 - Study Evaluating Prevenar in High-Risk Children N/A
Completed NCT01767402 - Study to Evaluate Safety, Reactogenicity and Immunogenicity of the Pneumococcal Protein PhtD Vaccine in Healthy Adults Phase 1
Active, not recruiting NCT05569954 - Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 50 Years of Age or Older (V116-010, STRIDE-10) Phase 3
Completed NCT01111214 - Child Pneumococcal Serotype Epidemiology In Greece N/A
Completed NCT01298544 - A Study to Assess the Antibody Response of Healthy Chinese Children Who Have Been Vaccinated Previously With 4-doses of Prevenar (a Pneumococcal Vaccine) as Babies and Toddlers Phase 4
Completed NCT04830358 - Safety and Immunogenicity of the 'EuPCV15' in Healthy Korean Adults Phase 1
Completed NCT04379713 - 20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants Phase 3
Completed NCT04887948 - Safety and Immunogenicity Study of 20vPnC When Coadministered With a Booster Dose of BNT162b2 Phase 3
Completed NCT04382326 - 20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants Phase 3
Not yet recruiting NCT00843895 - Multicenter Prospective Evaluation of the Incidence and Serotyes of Invasive Pneumoccocal Disease (IPD) Among Children Below 5 Years N/A
Completed NCT01734239 - A Phase III Clinical Trial to Study the Safety and Immunogenicity of Pneumovax™ 23 (V110) in Participants From the Russian Population (V110-018) Phase 3

External Links