Phase 1
N=800
Study Evaluating 7-Valent Pneumococcal Conjugate Vaccine in Healthy Infants
Pneumococcal Infections
Bottom Line
View on ClinicalTrials.gov: NCT00488826 ↗Enrolled (actual)
800
Serious AEs
—
Results posted
May 2009
Primary outcome: Primary: Concentration of Serotype-Specific IgG Antibodies — 15.26; 0.01; 3.1; 0.06 ug/ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- 7-valent pneumococcal conjugate vaccine (Biological); Diptheria and tetanus toxoids and accelular pertussis vaccine (DTaP) (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Primary completion
- —
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Concentration of Serotype-Specific IgG Antibodies |
8.99; 0.01; 1.19; 0.06; 4.9; 0.06 | — |
| SECONDARY Concentration of Serotype-Specific IgG Antibodies |
8.99; 0.01; 1.19; 0.06; 4.9; 0.06 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00488826). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.