Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

Phase 3

Completed

• Conditions: Vaccines, Pneumococcal
• Interventions: Biological: 13 valent pneumococcal conjugate vaccine with Polysorbate 80; Biological: 13 valent pneumococcal conjugate vaccine without Polysorbate 80

• Registration Number: NCT00366548
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine manufactured with Polysorbate 80 compared to a 13-valent pneumococcal conjugate (13vPnC) manufactured without Polysorbate 80 when given concomitantly with routine paediatric vaccinations.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-08-17
• Study First Submitted QC: 2006-08-18
• Study First Posted: 2006-08-21
• Study Start: 2006-11
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Disposition First Submitted: 2009-02-26
• Disposition First Submitted QC: 2009-07-31
• Disposition First Posted: 2009-10-01
• Results First Submitted: 2010-03-26
• Status Verified: 2012-07
• Results First Submitted QC: 2012-07-06
• Last Update Submitted: 2012-07-06
• Results First Posted: 2012-08-15
• Last Update Posted: 2012-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	13 valent pneumococcal conjugate vaccine with Polysorbate 80	-
2	13 valent pneumococcal conjugate vaccine without Polysorbate 80	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series	One month after 3-dose infant series (at 5 months of age)	Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/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.
Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series	One month after 3-dose infant series (at 5 months of age)	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose	one month after the toddler dose (at 13 months of age)	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.
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose	one month after the toddler dose (at 13 months of age)	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.