Vaccines, Pneumococcal Clinical Trial
Official title:
A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability and Immunologic Noninferiority of a 13-valent Pneumococcal Conjugate Vaccine Compared to a 7-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in the United States
Verified date | January 2013 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal vaccine (13vPnC) compare to the 7-valent pneumococcal vaccine (7vPnC) and to compare the immune response to concomitant vaccines administered with 13vPnC and 7vPnC.
Status | Completed |
Enrollment | 666 |
Est. completion date | June 2008 |
Est. primary completion date | June 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 42 Days to 98 Days |
Eligibility |
Inclusion Criteria: - Healthy 2-month-old infants. - Available for the entire study period. Exclusion criteria: - Previous vaccination with any vaccine before the start of the study. - Known contraindication to vaccination. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants Achieving Antibody Level =0.35 µg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series | Percentages of Participants achieving World Health Organization (WHO) predefined antibody threshold =0.35 µg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. | One month after the 3-dose infant series (7 months of age) | No |
Primary | Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose | Antibody concentration/geometric mean concentration as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. | 1 Month After the Toddler Dose | No |
Primary | Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series | Predefined Antibody Levels for Haemophilus Influenzae Type b ([Hib] 0.15 µg/mL or 1.0 µg/mL), Diphtheria Toxoid (0.1 International Units [IU]/mL), and Pertussis antigens (Pertussis filamentous hemagglutinin [FHA] 40.5 Elisa Units [EU]/mL, Pertussis toxoid [PT] 16.5 EU/mL, Pertussis pertactin [PRN] 26 EU/mL). | One Month After the Infant Series (7 months of age) | No |
Primary | Percentage of Participants Reporting Pre-specified Systemic Events | Systemic events (any fever [Fv] = 38 degrees Celsius [C], decreased (decr.) appetite, irritability, increased (incr.) sleep, decreased sleep, and hives [urticaria], use of antipyretic medication [med] to treat or prevent symptoms [sx]) were reported using an electronic diary. Participants may be represented in more than 1 category. | Within 7 days after each dose | Yes |
Primary | Percentage of Participants Reporting Pre-specified Local Reactions | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant ([Sig.], present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate ([Mod.], 2.5 to 7.0 cm); Severe ([Sev.], > 7.0 cm). Participants may have been represented in more than 1 category. | Within 7 days after each dose | Yes |
Secondary | Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Vaccine Antigens Induced by Measles, Mumps, Rubella, Varicella (MMR-V) and Haemophilus Influenzae Type b (Hib) | One month after toddler dose (13 to 16 months of age) | No | |
Secondary | Geometric Mean Antibody Concentration of Hib PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | one month after the toddler dose | No | |
Secondary | Geometric Mean Antibody Concentration of Measles, Mumps, and Varicella ELISA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | Normalization was performed for unit of measure "index value" as Index Value of 1.00 = 10 mIU/mL. | one month after the toddler dose | No |
Secondary | Geometric Mean Antibody Concentration of Rubella in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | one month after the toddler dose | No | |
Secondary | Percentage of Participants Achieving Functional Antibody Titer =1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose | Percentage of participants achieving functional antibody titer =1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. | One month after infant series and one month after toddler dose | No |
Secondary | Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose | Geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. | one month after the infant series and the toddler dose | No |
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