Safety Surveillance of Pneumococcal 13-valent Conjugate V... | NCT01396434

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Prevenar 13 patients			Biological: Prevenar 13

Name	Type	Description	Arm Group Labels	Other Names
Prevenar 13	Biological	Prevenar 13 vaccine as prescribed by the physician based on approved product indication	Prevenar 13 patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Baseline through and including 28 calendar days after the last administration of study vaccine within the observation period

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Private Clinic		Lipa City	Batangas		Philippines
Private Clinic

References Module

Label	URL
To obtain contact information for a study center near you, click here.	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	13vPnC (Prevenar 13), Cohort 1	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.
FG001	13vPnC (Prevenar 13), Cohort 2

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Arm/Group Information

ID	Title	Description
BG000	13vPnC (Prevenar 13), Cohort 1	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.
BG001	13vPnC (Prevenar 13), Cohort 2	13vPnC as prescribed by the physician based on approved product indication for adults 50 years and older.
BG002	13vPnC (Prevenar 13), Cohort 3	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.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Age at enrollment (years)

Title	Measurements
	BG0000.5± 0.94 BG00165.1± 10.60 BG0020.7± 1.54 BG003

Gender

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0001402 BG001115 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

Asian

Title	Measurements
	BG0002783 BG001175 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Participants who received at least 1 dose of 13vPnC.

Posted

Number

participants

Baseline through and including 28 calendar days after the last administration of study vaccine within the observation period

ID	Title	Description
OG000	13vPnC (Prevenar 13), Cohort 1	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.
OG001	13vPnC (Prevenar 13), Cohort 2	13vPnC as prescribed by the physician based on approved product indication for adults 50 years and older.
OG002	13vPnC (Prevenar 13), Cohort 3	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.

Units	Counts
Participants	OG0002817 OG001175 OG00214

Title

Denominators

Categories

AEs

Title	Measurements
	OG00068 OG0015 OG0020

SAEs

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	13vPnC (Prevenar 13), Cohort 1	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.	1	2,817	68	2,817
EG001	13vPnC (Prevenar 13), Cohort 2	13vPnC as prescribed by the physician based on approved product indication for adults 50 years and older.	0	175	5	175
EG002	13vPnC (Prevenar 13), Cohort 3	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.	0	14	0	14

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Bronchopneumonia	Infections and infestations	WHO Drug Dictionary	Non-systematic Assessment		EG0001 events1 affected2,817 at risk EG0010 events0 affected175 at risk EG0020 events0 affected14 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	WHO Drug Dictionary	Non-systematic Assessment	EG0001 events1 affected2,817 at risk EG0010 events0 affected175 at risk EG0020 events0 affected14 at risk
Pyrexia	General disorders	WHO Drug Dictionary	Non-systematic Assessment	EG00038 events38 affected2,817 at risk EG0012 events2 affected175 at risk EG0020 events0 affected14 at risk
Injection site pain	General disorders	WHO Drug Dictionary	Non-systematic Assessment	EG0003 events3 affected2,817 at risk EG0010 events0 affected175 at risk EG0020 events0 affected14 at risk
Swelling	General disorders	WHO Drug Dictionary	Non-systematic Assessment	EG0002 events2 affected2,817 at risk EG0010 events0 affected175 at risk EG0020 events0 affected14 at risk
Malaise	General disorders	WHO Drug Dictionary	Non-systematic Assessment	EG0000 events0 affected2,817 at risk EG0011 events1 affected175 at risk EG0020 events0 affected14 at risk
Injection site swelling	General disorders	WHO Drug Dictionary	Non-systematic Assessment	EG0001 events1 affected2,817 at risk EG0010 events0 affected175 at risk EG0020 events0 affected14 at risk
Injection site erythema	General disorders	WHO Drug Dictionary	Non-systematic Assessment	EG0001 events1 affected2,817 at risk EG0010 events0 affected175 at risk EG0020 events0 affected14 at risk
Crying	General disorders	WHO Drug Dictionary	Non-systematic Assessment	EG0001 events1 affected2,817 at risk EG0010 events0 affected175 at risk EG0020 events0 affected14 at risk
Upper respiratory tract infection	Infections and infestations	WHO Drug Dictionary	Non-systematic Assessment	EG0007 events7 affected2,817 at risk EG0010 events0 affected175 at risk EG0020 events0 affected14 at risk
Gastroenteritis	Infections and infestations	WHO Drug Dictionary	Non-systematic Assessment	EG0003 events3 affected2,817 at risk EG0010 events0 affected175 at risk EG0020 events0 affected14 at risk
Viral rash	Infections and infestations	WHO Drug Dictionary	Non-systematic Assessment	EG0002 events2 affected2,817 at risk EG0010 events0 affected175 at risk EG0020 events0 affected14 at risk
Rhinitis	Infections and infestations	WHO Drug Dictionary	Non-systematic Assessment	EG0002 events2 affected2,817 at risk EG0010 events0 affected175 at risk EG0020 events0 affected14 at risk
Respiratory tract infection	Infections and infestations	WHO Drug Dictionary	Non-systematic Assessment	EG0002 events2 affected2,817 at risk EG0010 events0 affected175 at risk EG0020 events0 affected14 at risk
Tonsillitis	Infections and infestations	WHO Drug Dictionary	Non-systematic Assessment	EG0000 events0 affected2,817 at risk EG0011 events1 affected175 at risk EG0020 events0 affected14 at risk
Pneumonia	Infections and infestations	WHO Drug Dictionary	Non-systematic Assessment	EG0001 events1 affected2,817 at risk EG0010 events0 affected175 at risk EG0020 events0 affected14 at risk
Pharyngitis	Infections and infestations	WHO Drug Dictionary	Non-systematic Assessment	EG0000 events0 affected2,817 at risk EG0011 events1 affected175 at risk EG0020 events0 affected14 at risk
Bronchopneumonia	Infections and infestations	WHO Drug Dictionary	Non-systematic Assessment	EG0001 events1 affected2,817 at risk EG0010 events0 affected175 at risk EG0020 events0 affected14 at risk
Amoebiasis	Infections and infestations	WHO Drug Dictionary	Non-systematic Assessment	EG0001 events1 affected2,817 at risk EG0010 events0 affected175 at risk EG0020 events0 affected14 at risk
Vaccination complication	Injury, poisoning and procedural complications	WHO Drug Dictionary	Non-systematic Assessment	EG0001 events1 affected2,817 at risk EG0010 events0 affected175 at risk EG0020 events0 affected14 at risk
Myopathy	Musculoskeletal and connective tissue disorders	WHO Drug Dictionary	Non-systematic Assessment	EG0000 events0 affected2,817 at risk EG0011 events1 affected175 at risk EG0020 events0 affected14 at risk
Headache	Nervous system disorders	WHO Drug Dictionary	Non-systematic Assessment	EG0000 events0 affected2,817 at risk EG0011 events1 affected175 at risk EG0020 events0 affected14 at risk
Restlessness	Psychiatric disorders	WHO Drug Dictionary	Non-systematic Assessment	EG0001 events1 affected2,817 at risk EG0010 events0 affected175 at risk EG0020 events0 affected14 at risk
Cough	Respiratory, thoracic and mediastinal disorders	WHO Drug Dictionary	Non-systematic Assessment	EG0001 events1 affected2,817 at risk EG0010 events0 affected175 at risk EG0020 events0 affected14 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	WHO Drug Dictionary	Non-systematic Assessment	EG0001 events1 affected2,817 at risk EG0010 events0 affected175 at risk EG0020 events0 affected14 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	WHO Drug Dictionary	Non-systematic Assessment	EG0001 events1 affected2,817 at risk EG0010 events0 affected175 at risk EG0020 events0 affected14 at risk
Dermatitis atopic	Skin and subcutaneous tissue disorders	WHO Drug Dictionary	Non-systematic Assessment	EG0001 events1 affected2,817 at risk EG0010 events0 affected175 at risk EG0020 events0 affected14 at risk
Angioedema	Skin and subcutaneous tissue disorders	WHO Drug Dictionary	Non-systematic Assessment	EG0001 events1 affected2,817 at risk EG0010 events0 affected175 at risk EG0020 events0 affected14 at risk

Certain Agreements

ID	Term
D013290	Streptococcal Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections