Vaccines, Pneumococcal Clinical Trial
Official title:
A Phase 3, Open Label, Single Arm Trial Evaluating the Safety, Tolerability, and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Mexico
The purpose of this study will be to evaluate safety, tolerability and immunogenicity of 13-valent pneumococcal vaccine in healthy infants given with routine pediatric vaccinations in Mexico.
Status | Completed |
Enrollment | 225 |
Est. completion date | May 2010 |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 42 Days to 98 Days |
Eligibility |
Inclusion Criteria: - Healthy 2 month infants, available for entire study period and parent/legal guardian reachable by telephone - Able to complete three blood draws during study - At least 3.5 kg at enrollment Exclusion Criteria: - Previous vaccination (except Hepatitis, BCG), contraindication or allergic reaction to vaccines - Immune deficiency, bleeding disorder or significant chronic medical condition |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Wyeth is now a wholly owned subsidiary of Pfizer |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (=) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series | Percentage of participants achieving predefined antibody threshold =0.35mcg/mL, along with the corresponding 95 percent confidence interval (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. Exact 2-sided CI based on the observed proportion of participants. | 1 month after the infant series (7 months of age) | No |
Secondary | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level =0.35mcg/mL, 1 Month After Dose 2 of the Infant Series | Percentage of participants achieving predefined antibody threshold =0.35mcg/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. Exact 2-sided CI based on the observed proportion of participants. | 1 month after dose 2 of the infant series (5 months of age) | No |
Secondary | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration =0.35mcg/mL, 1 Month After the Toddler Dose | Percentage of participants achieving predefined antibody threshold =0.35mcg/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. Exact 2-sided CI based on the observed proportion of participants. | 1 month after the toddler dose (13 months of age) | No |
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