Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants in Mexico
This study has been completed.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00708682
First received: June 27, 2008
Last updated: October 24, 2011
Last verified: October 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Vaccines, Pneumococcal |
Biological: 13-valent pneumococcal conjugate vaccine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Primary Outcome Measures:
- 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 [ Time Frame: 1 month after the infant series (7 months of age) ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series [ Time Frame: 1 month after dose 2 of the infant series (5 months of age) ] [ Designated as safety issue: No ]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.
- Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose [ Time Frame: 1 month after the toddler dose (13 months of age) ] [ Designated as safety issue: No ]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.
| Enrollment: | 225 |
| Study Start Date: | July 2008 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A | Biological: 13-valent pneumococcal conjugate vaccine |
Eligibility| Ages Eligible for Study: | 42 Days to 98 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00708682
Locations
| Mexico | |
| Guadalajara, Jalisco, Mexico, 44080 | |
| Morelia, Michoacan, Mexico, 58070 | |
| Cuernavaca, Morelos, Mexico, 62508 | |
| Monterrey, Nuevo Leon, Mexico, 64460 | |
| Merida, Yucatan, Mexico, 9700 | |
| Distrio Federal, Mexico, 14080 | |
| Distrio Federal, Mexico, 4530 | |
| Oaxaca, Mexico, 71220 | |
| Puebla, Mexico, 72190 | |
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
| Study Director: | Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer |
More Information
No publications provided
| Responsible Party: | Wyeth is now a wholly owned subsidiary of Pfizer |
| ClinicalTrials.gov Identifier: | NCT00708682 History of Changes |
| Other Study ID Numbers: | 6096A1-3009 |
| Study First Received: | June 27, 2008 |
| Results First Received: | January 28, 2011 |
| Last Updated: | October 24, 2011 |
| Health Authority: | Mexico: Ethics Committee Mexico: National Institute of Public Health, Health Secretariat United States: Food and Drug Administration |
ClinicalTrials.gov processed this record on June 17, 2013