Study Evaluating 13-valent Pneumococcal Conjugate Vaccine Catch-Up Regimens in Older Infants and Children - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00452452

Purpose

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent Pneumococcal conjugate vaccine (13vPnC) in older infants and children who have not previously been immunised with Pneumococcal vaccine.

Condition	Intervention	Phase
Pneumococcal Infections	Biological: 13-valent Pneumococcal Conjugate Vaccine	Phase III

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
Official Title:	A Phase 3 Open-label Trial Evaluating the Safety, Tolerability and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Older Infants and Children Who Are Naive to Previous Vaccination With Pneumococcal Conjugate Vaccine.

Resource links provided by NLM:

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

To assess the pneumococcal immune responses induced by 13vPnC when measured 1 month after the last scheduled dose of 13vPnC in each of 3 age groups (Group A = 7-11 months; Group B = 12-23 months; Group C = 24 months-5 years). [ Time Frame: 1 month after last dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the safety profile of 13vPnC as measured by the incidence rates of local reactions, systemic events and adverse events (AEs). [ Time Frame: 13 months ] [ Designated as safety issue: No ]

Enrollment:	354
Study Start Date:	May 2007
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Biological: 13-valent Pneumococcal Conjugate Vaccine

Eligibility

Ages Eligible for Study:	7 Months to 5 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria

Aged from 7 months to less than 6 years (72 months) at time of enrollment
Healthy child as determined by medical history, physical examination and judgment of the investigator
Available for the entire study period Exclusion Criteria
Previous vaccination with any pneumococcal vaccine
A previous anaphylactic reaction to any vaccine or vaccine-related component
Contraindication to vaccination with pneumococcal vaccines

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00452452

Locations

Poland

Debica, Poland, 39-200

Trzebnica, Poland, 55-100

Proznan, Poland, 61-709

Krakow, Poland, 31-503

Lodz, Poland, 91-738

Bydgoszcz, Poland, 85-168

Bydgoszcz, Poland, 85-316

Leczna, Poland, 21-010

Oborniki Salskie, Poland, 55-120

Sponsors and Collaborators

Wyeth

Investigators

Study Director:	Medical Monitor	Wyeth
Principal Investigator:	Trial Manager	For Poland: WPWZMED@wyeth.com

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	6096A1-3002
Study First Received:	March 23, 2007
Last Updated:	July 31, 2009
ClinicalTrials.gov Identifier:	NCT00452452 History of Changes
Health Authority:	Poland: Ministry of Health; United States: Food and Drug Administration

Keywords provided by Wyeth:

Pneumococcal Vaccines

Study placed in the following topic categories:

Bacterial Infections
Gram-Positive Bacterial Infections
Streptococcal Infections
Pneumococcal Infections

Additional relevant MeSH terms:

Bacterial Infections
Gram-Positive Bacterial Infections
Streptococcal Infections
Infection
Pneumococcal Infections

ClinicalTrials.gov processed this record on September 10, 2009