Safety Surveillance of Pneumococcal 13-valent Conjugate Vaccine Among Filipinos

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01396434
• Collaborator: (none)
• Enrollment: 3,006
• Locations: 121
• Duration (Months): 29
• Patients Per Site: 24.8
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

Prevenar 13 is safe for administration to Filipinos.

Condition or Disease	Intervention/Treatment	Phase
Pneumococcal Disease	Biological: Prevenar 13

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

• Study Type: Observational
• Actual Enrollment: 3006 participants
• Time Perspective: Prospective
• 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
• Study Start Date: Dec 1, 2011
• Actual Primary Completion Date: May 1, 2014
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Prevenar 13 patients	Biological: Prevenar 13; Prevenar 13 vaccine as prescribed by the physician based on approved product indication; Other Names: Pneumococcal 13-valent Conjugate Vaccine (13vPnC)

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Weeks and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

Patients prescribed with the vaccine

Exclusion Criteria:

Patients with hypersensitivity to the vaccine

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Private Clinic	Lipa City	Batangas	Philippines
2	Private Clinic	Tagbilaran City	Bohol	Philippines
3	Private Clinic	Malolos	Bulacan	Philippines
4	Room 220 The Doctor's Hospital, Inc.	Bacolod City	Negros Occidental	Philippines
5	Private Clinic	San Carlos City	Negros Occidental	Philippines
6	San Carlos Doctor's Hospital	San Carlos City	Negros Occidental	Philippines
7	Victorias Commercial Center	Victorias City	Negros Occidental	Philippines
8	Private Clinic	Dagupan City	Pangasinan	Philippines
9	Private Clinic	Mangaldan	Pangasinan	Philippines
10	Private Clinic	Pozorrubio	Pangasinan	Philippines
11	Private Clinic	Angeles City		Philippines
12	Private Clinic	Antipolo City		Philippines
13	Dr. Pablo O. Torre Memorial Medical Center	Bacolod City		Philippines	6100
14	Medical Arts Building	Bacolod CIty		Philippines
15	Medical Plaza	Bacolod City		Philippines
16	Private Clinic	Bacolod City		Philippines
17	Riverside Medical Center	Bacolod City		Philippines
18	Room 302 Medical Arts Building	Bacolod City		Philippines
19	Room 311 Riverside Medical Arts Building	Bacolod City		Philippines
20	Villanueva Laboratory and Clinics	Bacolod City		Philippines
21	Private Clinic	Batangas City		Philippines
22	MCA Bauanan Children's Clinic	Batangas		Philippines
23	Private Clinic	Batangas		Philippines
24	Metropolitan Medical Center	Binondo, Manila		Philippines
25	Private Clinic	Bocaue		Philippines
26	417	Bulacan		Philippines
27	Clinica Tapia	Bulacan		Philippines
28	Pediatric Doctor's Clinic	Bulacan		Philippines
29	Private Clinic	Bulacan		Philippines
30	St Vincent's Wellness Clinic	Bulacan		Philippines
31	Room 11	Cagayan De Oro City		Philippines
32	Centralle Medical Diagnostics and Polyclinic	Caloocan City		Philippines
33	Private Clinic	Caloocan City		Philippines
34	Private Clinic	Candelaria City		Philippines
35	Blk 19 Lot 11	Capiz City		Philippines
36	Private Clinic	Cavite		Philippines
37	Basement	Cebu City		Philippines
38	Care and Cure Hub	Cebu City		Philippines
39	Cebu Doctors University Hopsital	Cebu City		Philippines
40	Chong Hua Hospital	Cebu City		Philippines
41	PPG, Manila, Philippines	Cebu City		Philippines
42	Private Clinic	Cebu City		Philippines
43	Rm4A, Medical Arts Building	Cebu City		Philippines
44	Room 302-A	Cebu City		Philippines
45	Room 413 Medical Arts Building 2	Cebu City		Philippines
46	Room 419 SPC Medical Specialty Center	Cebu City		Philippines
47	Room 505A Chong Hua Medical Arts Building	Cebu City		Philippines
48	Cebu Doctor University Hospital	Cebu		Philippines	6000
49	Chong Hua Hospital	Cebu		Philippines	6000
50	Chong Hua Hospital	Cebu		Philippines
51	Private Clinic	Dagupan City		Philippines
52	Community Health and Development Cooperative Hospital	Davao City		Philippines
53	Health Science and Wellness Center	Davao City		Philippines
54	Jesusa Complex	Davao City		Philippines
55	Private Clinic	Davao City		Philippines
56	San Pedro Hospital Inc.	Davao City		Philippines
57	San Pedro Hospital	Davao City		Philippines
58	Private Clinic	Dipolog City		Philippines
59	Private Clinic	Dumaguete City		Philippines
60	Room 117 Medical Arts Building	Dumaguete City		Philippines
61	Iligan Specialist Clinic	Iligan City		Philippines
62	Private Clinic	Iloilo City		Philippines
63	Private Clinic	Koronadal City		Philippines
64	Private Clinic	Laguna		Philippines
65	Las Pinas Doctors Hospital	Las Pinas City		Philippines
66	Private Clinic	Legaspi City		Philippines
67	Private Clinic	Lipa City		Philippines
68	Lucena United Doctors Hospital	Lucena City		Philippines
69	Private Clinic	Lucena City		Philippines
70	Private Clinic	Makati City		Philippines
71	Archangel Raphael Pediatric Clinic	Malabon City		Philippines
72	Children's Clinic	Malabon City		Philippines
73	Malabon Medical Clinic	Malabon City		Philippines
74	Tumbicon Polycare	Malabon		Philippines
75	Private Clinic	Malolos City		Philippines
76	Private Clinic	Mandaluyong City		Philippines
77	Metropolitan Medical Center	Manila		Philippines	1000
78	1952	Manila		Philippines
79	Children's Clinic	Manila		Philippines
80	Chinese General Hospital	Manila		Philippines
81	Private Clinic	Manila		Philippines
82	Rm714B	Manila		Philippines
83	Room 210, Metropolitan Medical Center	Manila		Philippines
84	Room 706	Manila		Philippines
85	Marikina Valley Medical Center	Marikina City		Philippines	1801
86	Centro Medical and Laboratory Clinic	Marikina City		Philippines
87	Garcia General Hospital	Marikina City		Philippines
88	Private Clinic	Marikina City		Philippines
89	Room 605	Marikina City		Philippines
90	Private Clinic	Negors Occidental		Philippines
91	Private Clinic	Negros Occidental		Philippines
92	Mabalacat Child Care Clinic	Pampanga		Philippines
93	Private Clinic	Pangasinan		Philippines
94	Maglana Villamor Clinic	Paranaque		Philippines
95	Paranaque Doctors Hospital	Paranaque		Philippines
96	Private Clinic	Pasig City		Philippines
97	Private Clinic	Pasig		Philippines
98	Philippine Heart Center	Quezon City		Philippines	1100
99	Friendly Care Clinic	Quezon City		Philippines
100	Madrid Polyclinic	Quezon CIty		Philippines
101	Maternity and Children's Clinic	Quezon City		Philippines
102	Medical Specialist Clinic	Quezon City		Philippines
103	Natividad Children's Clinic	Quezon City		Philippines
104	Philippine Heart Center	Quezon City		Philippines
105	Private Clinic	Quezon City		Philippines
106	Room 11	Quezon City		Philippines
107	World Citi Medical Center	Quezon City		Philippines
108	Emil-Joanna General Hospital	Quezon		Philippines
109	Private Clinic	Quezon		Philippines
110	Children'S Clinic	Rizal		Philippines
111	Private Clinic	Rizal		Philippines
112	Community General Hospital	San Pablo City		Philippines
113	Private Clinic	San Pablo City		Philippines
114	Private Clinic	South Luzon		Philippines
115	Chinese General Hospital and Medical Center	Sta. Cruz, Manila		Philippines
116	Private Clinic	Tagbilaran City		Philippines
117	Private Clinic	Tarlac City		Philippines
118	Private Clinic	Urdaneta City		Philippines
119	Private Clinic	Valenzuela City		Philippines
120	Private Clinic	Zamboanga City		Philippines
121	Room 331	Zamboanga City		Philippines

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01396434
• Other Study ID Numbers: B1851076
• First Posted: Jul 18, 2011
• Last Update Posted: Jan 30, 2017
• Last Verified: Jan 1, 2016

• Additional relevant MeSH terms: Pneumococcal Infections; Heptavalent Pneumococcal Conjugate Vaccine

Study Results

Participant Flow

Arm/Group Title	13vPnC (Prevenar 13), Cohort 1	13vPnC (Prevenar 13), Cohort 2	13vPnC (Prevenar 13), Cohort 3
Arm/Group Description	Pneumococcal 13-valent conjugate vaccine (13vPnC) as prescribed by the physician based on approved product indication for infants and children 6 weeks through 5 years of age.	13vPnC as prescribed by the physician based on approved product indication for adults 50 years and older.	13vPnC as prescribed by the physician based on approved product indication. These participants may have had incorrect documentation of their 13vPnC vaccine date(s) and were neither included in the 6 weeks through 5 years of age nor 50 years and older indication group.
Period Title: Overall Study
STARTED	2817	175	14
COMPLETED	2806	175	14
NOT COMPLETED	11	0	0

Baseline Characteristics

Arm/Group Title	13vPnC (Prevenar 13), Cohort 1	13vPnC (Prevenar 13), Cohort 2	13vPnC (Prevenar 13), Cohort 3	Total
Arm/Group Description	Pneumococcal 13-valent conjugate vaccine (13vPnC) as prescribed by the physician based on approved product indication for infants and children 6 weeks through 5 years of age.	13vPnC as prescribed by the physician based on approved product indication for adults 50 years and older.	13vPnC as prescribed by the physician based on approved product indication. These participants may have had incorrect documentation of their 13vPnC vaccine date(s) and were neither included in the 6 weeks through 5 years of age nor 50 years and older indication group.	Total of all reporting groups
Overall Participants	2817	175	14	3006
Age (years) [Mean (Standard Deviation) ]
Age at enrollment (years)	0.5 (0.94)	65.1 (10.60)	0.7 (1.54)	4.3 (15.37)
Gender (Count of Participants)
Female	1402 49.8%	115 65.7%	6 42.9%	1523 50.7%
Male	1415 50.2%	60 34.3%	8 57.1%	1483 49.3%
Race/Ethnicity, Customized (participants) [Number]
Asian	2783 98.8%	175 100%	14 100%	2972 98.9%
Other	24 0.9%	0 0%	0 0%	24 0.8%
White	8 0.3%	0 0%	0 0%	8 0.3%
Black	2 0.1%	0 0%	0 0%	2 0.1%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description	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.
Time Frame	Baseline through and including 28 calendar days after the last administration of study vaccine within the observation period

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of 13vPnC.

Arm/Group Title	13vPnC (Prevenar 13), Cohort 1	13vPnC (Prevenar 13), Cohort 2	13vPnC (Prevenar 13), Cohort 3
Arm/Group Description	Pneumococcal 13-valent conjugate vaccine (13vPnC) as prescribed by the physician based on approved product indication for infants and children 6 weeks through 5 years of age.	13vPnC as prescribed by the physician based on approved product indication for adults 50 years and older.	13vPnC as prescribed by the physician based on approved product indication. These participants may have had incorrect documentation of their 13vPnC vaccine date(s) and were neither included in the 6 weeks through 5 years of age nor 50 years and older indication group.
Measure Participants	2817	175	14
AEs	68 2.4%	5 2.9%	0 0%
SAEs	1 0%	0 0%	0 0%

Adverse Events

Adverse Event Reporting Description	The same event may appear as both an 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 experienced both a serious and non-serious event during the study.
Arm/Group Title	13vPnC (Prevenar 13), Cohort 1		13vPnC (Prevenar 13), Cohort 2		13vPnC (Prevenar 13), Cohort 3
Arm/Group Description	Pneumococcal 13-valent conjugate vaccine (13vPnC) as prescribed by the physician based on approved product indication for infants and children 6 weeks through 5 years of age.		13vPnC as prescribed by the physician based on approved product indication for adults 50 years and older.		13vPnC as prescribed by the physician based on approved product indication. These participants may have had incorrect documentation of their 13vPnC vaccine date(s) and were neither included in the 6 weeks through 5 years of age nor 50 years and older indication group.
All Cause Mortality
	13vPnC (Prevenar 13), Cohort 1		13vPnC (Prevenar 13), Cohort 2		13vPnC (Prevenar 13), Cohort 3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	13vPnC (Prevenar 13), Cohort 1		13vPnC (Prevenar 13), Cohort 2		13vPnC (Prevenar 13), Cohort 3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/2817 (0%)		0/175 (0%)		0/14 (0%)
Infections and infestations
Bronchopneumonia	1/2817 (0%)	1	0/175 (0%)	0	0/14 (0%)	0
Other (Not Including Serious) Adverse Events
	13vPnC (Prevenar 13), Cohort 1		13vPnC (Prevenar 13), Cohort 2		13vPnC (Prevenar 13), Cohort 3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	68/2817 (2.4%)		5/175 (2.9%)		0/14 (0%)
Gastrointestinal disorders
Diarrhoea	1/2817 (0%)	1	0/175 (0%)	0	0/14 (0%)	0
General disorders
Pyrexia	38/2817 (1.3%)	38	2/175 (1.1%)	2	0/14 (0%)	0
Injection site pain	3/2817 (0.1%)	3	0/175 (0%)	0	0/14 (0%)	0
Swelling	2/2817 (0.1%)	2	0/175 (0%)	0	0/14 (0%)	0
Malaise	0/2817 (0%)	0	1/175 (0.6%)	1	0/14 (0%)	0
Injection site swelling	1/2817 (0%)	1	0/175 (0%)	0	0/14 (0%)	0
Injection site erythema	1/2817 (0%)	1	0/175 (0%)	0	0/14 (0%)	0
Crying	1/2817 (0%)	1	0/175 (0%)	0	0/14 (0%)	0
Infections and infestations
Upper respiratory tract infection	7/2817 (0.2%)	7	0/175 (0%)	0	0/14 (0%)	0
Gastroenteritis	3/2817 (0.1%)	3	0/175 (0%)	0	0/14 (0%)	0
Viral rash	2/2817 (0.1%)	2	0/175 (0%)	0	0/14 (0%)	0
Rhinitis	2/2817 (0.1%)	2	0/175 (0%)	0	0/14 (0%)	0
Respiratory tract infection	2/2817 (0.1%)	2	0/175 (0%)	0	0/14 (0%)	0
Tonsillitis	0/2817 (0%)	0	1/175 (0.6%)	1	0/14 (0%)	0
Pneumonia	1/2817 (0%)	1	0/175 (0%)	0	0/14 (0%)	0
Pharyngitis	0/2817 (0%)	0	1/175 (0.6%)	1	0/14 (0%)	0
Bronchopneumonia	1/2817 (0%)	1	0/175 (0%)	0	0/14 (0%)	0
Amoebiasis	1/2817 (0%)	1	0/175 (0%)	0	0/14 (0%)	0
Injury, poisoning and procedural complications
Vaccination complication	1/2817 (0%)	1	0/175 (0%)	0	0/14 (0%)	0
Musculoskeletal and connective tissue disorders
Myopathy	0/2817 (0%)	0	1/175 (0.6%)	1	0/14 (0%)	0
Nervous system disorders
Headache	0/2817 (0%)	0	1/175 (0.6%)	1	0/14 (0%)	0
Psychiatric disorders
Restlessness	1/2817 (0%)	1	0/175 (0%)	0	0/14 (0%)	0
Respiratory, thoracic and mediastinal disorders
Cough	1/2817 (0%)	1	0/175 (0%)	0	0/14 (0%)	0
Skin and subcutaneous tissue disorders
Rash maculo-papular	1/2817 (0%)	1	0/175 (0%)	0	0/14 (0%)	0
Dermatitis contact	1/2817 (0%)	1	0/175 (0%)	0	0/14 (0%)	0
Dermatitis atopic	1/2817 (0%)	1	0/175 (0%)	0	0/14 (0%)	0
Angioedema	1/2817 (0%)	1	0/175 (0%)	0	0/14 (0%)	0

Limitations/Caveats

The use of 13vPnC was based on the investigator's clinical judgment and was assumed to be consistent with the product's approved label.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.