Study Evaluating 7-Valent Pneumococcal Conjugate Vaccine in Healthy Infants

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00488826
First received: June 18, 2007
Last updated: January 15, 2010
Last verified: January 2010
  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 7-Valent Pneumococcal Conjugate Vaccine (7vPnC)in healthy Chinese infants. Both phases include a Primary Series which includes the primary 3 doses of 7vPnC and /or Diptheria and tetanus toxoids and accelular pertussis vaccine (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
Pneumococcal Infections
Biological: 7-valent pneumococcal conjugate vaccine
Biological: Diptheria and tetanus toxoids and accelular pertussis vaccine (DTaP)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Concentration of Serotype-Specific IgG Antibodies [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Concentration of Serotype-Specific IgG Antibodies [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]

Enrollment: 800
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00488826     History of Changes
Other Study ID Numbers: 0887X-101518
Study First Received: June 18, 2007
Results First Received: March 31, 2009
Last Updated: January 15, 2010
Health Authority: China: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Vaccines, Pneumococcal Conjugate Vaccine

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on August 21, 2014