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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00708682
Other study ID # 6096A1-3009
Secondary ID
Status Completed
Phase Phase 3
First received June 27, 2008
Last updated October 24, 2011
Start date July 2008
Est. completion date May 2010

Study information

Verified date October 2011
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority Mexico: Ethics CommitteeMexico: National Institute of Public Health, Health SecretariatUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
13-valent pneumococcal conjugate vaccine


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Mexico, 

Outcome

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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