Study Evaluating 7-Valent Pneumococcal Conjugate Vaccine in Healthy Infants

NCT00488826 | Completed Phase 1 Results

• 1 other identifier: 0887X-101518
• Study Type: interventional
• Target: 800
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pneumococcal Infections

Keywords

Vaccines, Pneumococcal Conjugate Vaccine

Outcome Measures

Primary Outcomes (1)

• Concentration of Serotype-Specific IgG Antibodies

  Vaccine efficacy can be assessed by measuring the levels of antibodies to the specific types (or serotypes) of bacteria covered by the vaccine. IgG antibodies for the 7 pneumococcal serotypes in 7vPnC (4, 6B, 9V, 14, 18C, 19F, 23F) were assessed 30-50 days after the third dose of vaccine. Antibody levels were measured by standardized enzyme-linked immunosorbent assay (ELISA). The minimum level of antibodies required to confer protection has been defined as 0.15 ug/ml by the Northern California Kaiser Permanente (NCKP) study, and as 0.35 ug/ml by the World Health Organization (WHO).

  7 months

Secondary Outcomes (1)

• Concentration of Serotype-Specific IgG Antibodies

  7 months

Interventions

7-valent pneumococcal conjugate vaccine BIOLOGICAL

Diptheria and tetanus toxoids and accelular pertussis vaccine (DTaP) BIOLOGICAL

Eligibility Criteria

• Age: 90 Days - 120 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

Heptavalent Pneumococcal Conjugate Vaccine; Tetanus Toxoid

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Pneumococcal Vaccines; Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined; Toxoids

Results Point of Contact

• Title: U. S. Contact Center
• Organization: Wyeth

clintrialresults@wyeth.com

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 18, 2007
• First Posted: June 20, 2007
• Study Start: October 1, 2005
• Study Completion: May 1, 2007
• Last Updated: January 20, 2010
• Results First Posted: May 27, 2009

Record last verified: 2010-01