Study Evaluating 7-Valent Pneumococcal Conjugate Vaccine in Healthy Infants - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00488826

Purpose

This study is a combination of a Phase I and Phase III study design. The Phase I portion is an open-label, controlled study to evaluate the safety of 7vPnC in healthy Chinese infants. The Phase III portion is an open-label, controlled, randomized study to evaluate the safety and immunogenicity of 7vPnC in healthy Chinese infants. Both phases include a Primary Series which includes the primary 3 doses of 7vPnC and /or DTaP at about 3, 4, and 5 months of age; and a Booster Dose which includes the 4th dose of 7vPnC at 12-15 months of age.

Condition	Intervention	Phase
Vaccines, Pneumococcal Conjugate Vaccine	Biological: 7-valent pneumococcal conjugate vaccine	Phase I

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Open-Label Controlled Phase I/III Study to Evaluate the Safety and Immunogenicity of Pneumococcal 7-Valent Conjugate Vaccine [DIPHTHERIA CRM197 PROTEIN] (PrevenarTM) in Healthy Infants

Further study details as provided by Wyeth:

Primary Outcome Measures:

1. Local and systemic reactions post each vaccination of the primary series 2. Serum levels of the vaccine-serotypes antibodies post the primary series

Secondary Outcome Measures:

1. Local and systemic reacions post the booster dose 2. Serum levels of the vaccine-serotypes antibodies pre and post the booster dose

Estimated Enrollment:	823
Study Start Date:	October 2005
Study Completion Date:	May 2007

Show Detailed Description

Eligibility

Ages Eligible for Study:	90 Days to 120 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Chinese infants, aged 3-4 months (90-120 days) at enrollment, and have not received their 1st dose of DTaP
In good health determined by medical history, physical examination (axillary temperature and weight) and clinical judgment of the investigator
An informed consent form must be signed by at least one of the parent/legal guardian. The parent or legal guardian are willing to adhere to the regimen of the study and are capable of using the thermometer, calipers and filling out the diary card

Exclusion Criteria:`

Weight < 2 SD for age
History of neurological disorders including a personal and family history of convulsion and epilepsy (including febrile seizures)
Receipt of blood products, including gamma globulin within 12 weeks prior to study entry
Hypersensitivity to any component of 7vPnC, including diphtheria toxoid
Known previous anaphylactic reactions to any vaccines or medicines
Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection
Known or suspected impairment of immune function due to the use of immunosuppressive therapy (including irradiation, corticosteroids, antimetabolites, alkylating agents, and cytotoxic agents), a genetic defect, HIV infection or other cause
History of culture-proven invasive disease caused by S. pneumoniae
Any significant congenital deformity or serious chronic diseases
Previous immunization with licensed or investigational pneumococcal vaccine
Other investigational medicine is being administered or has been administered within 12 weeks before screening or participation in another investigational study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00488826

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Study ID Numbers:	0887X-101518
Study First Received:	June 18, 2007
Last Updated:	December 4, 2007
ClinicalTrials.gov Identifier:	NCT00488826
Health Authority:	China: State Food and Drug Administration

Study placed in the following topic categories:

Healthy
Diphtheria

ClinicalTrials.gov processed this record on January 16, 2009