Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants in Mexico

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00708682
• Other study ID #: 6096A1-3009
• 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

• Vaccines, Pneumococcal

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