Other Clinical Trial - Post-Marketing Study of the Safety NCT00683410

Updated 06/21/2024

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT00683410
Other study ID #	0887X-102339
Secondary ID
Status	Completed
Phase	N/A
First received	May 21, 2008
Last updated	October 15, 2010
Start date	April 2007
Est. completion date	October 2009

Study information
Verified date	October 2010
Source	Wyeth is now a wholly owned subsidiary of Pfizer
Contact	n/a
Is FDA regulated	No
Health authority	Philippines: Bureau of Food and Drugs
Study type	Observational

Clinical Trial Summary

To collect post-marketing information on the safety of Prevenar in Filipino patients

Recruitment information / eligibility
Status	Completed
Enrollment	3366
Est. completion date	October 2009
Est. primary completion date	October 2009
Accepts healthy volunteers	Accepts Healthy Volunteers
Gender	Both
Age group	N/A and older
Eligibility	Inclusion Criteria: - All patients from the study center who received or will receive at least one dose of Prevenar according to the approved product indication. Exclusion Criteria: - Previously discontinued Prevenar therapy due to safety concerns.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Vaccines, Pneumococcal Conjugate Vaccine

Intervention

Biological:
• Pneumococcal Conjugate Vaccine, 7-valent (Prevenar)

Locations
Country	Name	City	State
n/a

Sponsors *(1)*
Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Philippines,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Spontaneous Adverse Events		30 days post injection up to 3 years	Yes

See also
	Status	Clinical Trial	Phase
	Completed	`NCT00574795` - Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Infants	Phase 3
	Completed	`NCT00269672` - Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Elderly Subjects	Phase 2
	Completed	`NCT00580684` - Study Comparing Prevenar® to Pneumo 23 in Reducing Carriage in Children	Phase 4
	Completed	`NCT00500357` - Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Elderly Subjects	Phase 3
	Completed	`NCT00581620` - Study Evaluating Prevenar Immunogenicity in High Risk Children	Phase 4
	Completed	`NCT00475033` - Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants	Phase 3
	Completed	`NCT00980655` - Study to Evaluate 13 Valent Pneumococcal Conjugate Vaccine (13vPnC) Vaccine Followed by 23-valent Pneumococcal Polysaccharide Vaccine (23vPS) Vaccine in Allogeneic Hematopoietic Stem Cell Transplant Recipients	Phase 3
	Completed	`NCT00676091` - Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in Brazil	Phase 3