Vaccines, Pneumococcal Clinical Trial
Official title:
A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With a Meningococcal C-Tetanus Toxoid Conjugate Vaccine and Other Routine Pediatric Vaccinations in Spain
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations in Spain.
Status | Completed |
Enrollment | 449 |
Est. completion date | March 2009 |
Est. primary completion date | March 2009 |
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 (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Wyeth is now a wholly owned subsidiary of Pfizer |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Percentage of Participants Reporting Pre-Specified Local Reactions | Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig)(present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness 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 be represented in more than 1 category. | During the 4-day period after each dose | Yes |
Other | Percentage of Participants Reporting Pre-Specified Systemic Events | Systemic events (fever [Fv] = 37.5 degrees Celsius [C], fever = 38 C but = 39 C, fever >39 C but = 40 C, fever > 40 C, decreased (Decr) appetite, irritability, increased (Incr) sleep, decreased sleep, hives, use of medication (Meds) to treat symptoms (Sx), and use of medication to prevent symptoms were reported using an electronic diary. Participants may be represented in more than 1 category. | During the 4-day period after each dose | Yes |
Primary | Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer = 1:8 in 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series | Percentage of participants achieving a meningococcal C SBA serum antibody titer greater than or equal to (=) 1:8 along with the corresponding 95% confidence interval (CI) are presented. | One month after infant series dose (at 5 months of age) | No |
Primary | Geometric Mean Titers (GMT) for Meningococcal C Antibodies in as Measured by Serum Bactericidal Assay (SBA) 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series and the Toddler Dose | One month after infant series dose 2 (at 5 months of age) and one month after toddler dose (at 16 months of age) | No | |
Primary | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose | Predefined antibody levels for Diphtheria (0.01 or 0.1 International units [IU]/mL) and Tetanus (0.01 or 0.1 [IU]/mL). | One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age) | No |
Primary | Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose | One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age) | No | |
Primary | Percentage of Participants Achieving Antibody Level = 0.35µg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | 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 infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age) | No |
Primary | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose | GMC 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. GMCs (13vPnC) were calculated for each pneumococcal serotype and timepoint, and 2-sided, 95% CI were constructed. | One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age) | No |
Secondary | Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer = 1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose | Percentage of participants achieving a meningococcal C SBA serum antibody titer = 1:8 along with the corresponding 95% confidence interval (CI) are presented. | One month after toddler dose (at 16 months of age) | No |
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