Study Evaluating Prevenar Vaccine in Healthy Infants - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00276107

Purpose

To determine the immunogenicity of Prevenar in infants immunized at 2, 4 and 6 months of age. To determine the antibody responses to the seven pneumococcal vaccine serotypes one month after second dose and determine the safety of Prevenar in infants immunized at 2,4 and 6 months of age.

Condition	Intervention	Phase
Pneumococcal Infections	Biological: Prevenar	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	An Open-Label Trial of the Immunogenicity and Safety of Prevenar (Pneumococcal 7-Valent Conjugate Vaccine [Diphteria CRM197 Protein Conjugate]) in Healthy Infants at 2, 4 and 6 Months of Age

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 determine the immunogenicity of Prevenar in infants immunized at 2, 4 and 6 months of age

Secondary Outcome Measures:

To determine the antibody responses to the seven pneumococcal vaccine serotypes after second dose and to determine the safety of Prevenar in infants immunized at 2, 4 and 6 months of age

Estimated Enrollment:	200
Study Start Date:	December 2004
Estimated Study Completion Date:	December 2005

Eligibility

Ages Eligible for Study:	42 Days to 100 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy male and female children 2 months of age (42 to 100 days) in good health.
An informed consent must be signed by a parent or legal guardian following a detailed explanation of participation in the study.
Infants whose parent(s)/guardian(s) will be available for the entire study period.

Exclusion Criteria:

Hypersensitivity to any component of the vaccine, including diphtheria toxoid
Infants with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection
Infants with known or suspected impairment of immunologic functions including HIV or those receiving immunosuppressive therapy.

Other exclusions apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00276107

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Study ID Numbers:	0887X-101446
Study First Received:	January 11, 2006
Last Updated:	July 28, 2009
ClinicalTrials.gov Identifier:	NCT00276107 History of Changes
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Wyeth:

Vaccine
Healthy Infants

Study placed in the following topic categories:

Bacterial Infections
Gram-Positive Bacterial Infections
Streptococcal Infections

Healthy
Diphtheria
Pneumococcal Infections

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on September 11, 2009