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

Phase 3

Completed

• Conditions: Vaccines, Pneumococcal
• Interventions: Biological: 13-valent pneumococcal conjugate vaccine; Biological: 7-valent pneumococcal conjugate vaccine

• Registration Number: NCT00474539
• 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 compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations in Spain.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-05-15
• Study First Submitted QC: 2007-05-15
• Study First Posted: 2007-05-17
• Study Start: 2007-07
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Results First Submitted: 2010-03-26
• Status Verified: 2013-01
• Results First Submitted QC: 2013-01-22
• Last Update Submitted: 2013-01-22
• Results First Posted: 2013-03-05
• Last Update Posted: 2013-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 449

Inclusion Criteria

• Healthy 2-month-old infants
• Available for the entire study period

Exclusion criteria:

• Previous vaccination with any vaccine before the start of the study
• Known contraindication to vaccination

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	13-valent pneumococcal conjugate vaccine	-
2	7-valent pneumococcal conjugate vaccine	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series	One month after infant series dose (at 5 months of age)	Percentage of participants achieving a meningococcal C SBA serum antibody titer greater than or equal to (≥) 1:8 along with the corresponding 95% confidence interval (CI) are presented.
Geometric Mean Titers (GMT) for Meningococcal C Antibodies in as Measured by Serum Bactericidal Assay (SBA) 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series and the Toddler Dose	One month after infant series dose 2 (at 5 months of age) and one month after toddler dose (at 16 months of age)
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose	One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)	Predefined antibody levels for Diphtheria (0.01 or 0.1 International units \[IU\]/mL) and Tetanus (0.01 or 0.1 \[IU\]/mL).
Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose	One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)
Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose	One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 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 After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose	One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 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. GMCs (13vPnC) were calculated for each pneumococcal serotype and timepoint, and 2-sided, 95% CI were constructed.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose	One month after toddler dose (at 16 months of age)	Percentage of participants achieving a meningococcal C SBA serum antibody titer ≥ 1:8 along with the corresponding 95% confidence interval (CI) are presented.