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Also known as 7-Valent Pneumococcal Conjugate Vaccine (7vPnC), 7-valent pneumococcal conjugate vaccine (vaccine), 7 valent pneumococcal conjugate vaccine, 7-valent pneumococcal conjugate vaccine (7vPnC), 7-Valent Pneumococcal Conjugate Vaccine (7vPnc)
7-valent pneumococcal conjugate vaccine · 3 trials · 3 indications
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).
| Arm | Type | Description |
|---|---|---|
| 7vPnC (3-, 4-, 5-, 12-Month) | ACTIVE_COMPARATOR | - |
| 13vPnC (3-, 4-, 5-, 12-Month) | EXPERIMENTAL | - |
| 13vPnC (2-, 4-, 6-, 12-Month) | EXPERIMENTAL | - |
| 13vPnC (3-, 5-, 12-Month) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| 7-valent Pneumococcal Conjugate Vaccine | BIOLOGICAL | suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 4-Month Visit, 5-Month Visit, and 12-Month Visit, respectively |
| 13-valent Pnumococcal Conjugate vaccine | BIOLOGICAL | suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 4-Month Visit, 5-Month Visit, and 12-Month Visit, respectively |
| 7-valent pneumococcal conjugate vaccine (vaccine) | BIOLOGICAL | - |
| 23-valent pneumococcal conjugate vaccine (vaccine) | BIOLOGICAL | - |
| Diptheria and tetanus toxoids and accelular pertussis vaccine (DTaP) | BIOLOGICAL | - |
Inclusion Criteria: 1. Aged 42 to 77 days (approximately 2 months) at the time of enrollment. 2. Healthy infant as determined by medical history, physical examination, and judgment of the investigator. Exclusion Criteria: 1. Previous vaccination with licensed or investigational pneumococcal vacci...
The 7-valent pneumococcal conjugate vaccine is a vaccine developed for the prevention of pneumococcal infection and is also being studied in people with HIV infections. It is designed to stimulate immune responses against pneumococcal disease, and clinical research has evaluated its use in both healthy infants and HIV-infected adults.
The 7-valent pneumococcal conjugate vaccine is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the company associated with the clinical development program for this vaccine across its studied indications.
The 7-valent pneumococcal conjugate vaccine is in Phase 2 clinical development. It is an investigational vaccine and is not approved. Its clinical program includes completed Phase 1, Phase 2, and Phase 3 studies, with the Phase 2 stage reflecting the highest phase reached for the HIV infections indication.
Three completed trials are associated with the 7-valent pneumococcal conjugate vaccine: NCT00488826, a Phase 1 study in healthy infants; NCT00148824, a Phase 2 study of antibody responses among HIV-infected adults in France; and NCT01692886, a Phase 3 study of the 13-valent pneumococcal conjugate vaccine in healthy infants in China.
Yes. The 7-valent pneumococcal conjugate vaccine is also known as 7vPnC, short for 7-valent pneumococcal conjugate vaccine. Other common forms of the name include 7 valent pneumococcal conjugate vaccine and 7-Valent Pneumococcal Conjugate Vaccine, all referring to the same vaccine.
Across its clinical program, 2,474 participants have been enrolled in trials of the 7-valent pneumococcal conjugate vaccine. The studies were randomized, and enrollment included healthy infants as well as HIV-infected adults, with the largest single trial enrolling 1,674 participants.