Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Children

A Phase 3, Open-Label Trial, Evaluating the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine in Healthy Children Previously Partially Immunized With Prevenar

The purposes of this study are to evaluate the safety of 13-valent pneumococcal Conjugate Vaccine (13vPnC) in children who have already been vaccinated with Prevenar. The study will also assess the immunological response (measure the amount of antibodies, i.e. proteins that fight off germs) produced by children after they have been given the 13-valent pneumococcal vaccine at 5 and 12 months or 12 months of age. In addition, reactions at the injection site will be assessed during the study.

Study Overview

• Status: Completed
• Conditions: Pneumococcal Vaccines
• Intervention / Treatment: Biological: 13vPnC; Biological: 13vPnC

• Study Type: Interventional
• Enrollment (Actual): 234
• Phase: Phase 3

Contacts and Locations

Study Locations

• Sweden
  • Eskilstuna, Sweden, SE-63188
    • Pfizer Investigational Site
  • Goteborg, Sweden, SE-40014
    • Pfizer Investigational Site
  • Malmo, Sweden, SE-20502
    • Pfizer Investigational Site
  • Orebro, Sweden, SE-70185
    • Pfizer Investigational Site
  • Ostersund, Sweden, SE-83183
    • Pfizer Investigational Site
  • Uddevalla, Sweden, SE-45180
    • Pfizer Investigational Site
  • Umea, Sweden, SE-90185
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 months to 1 year (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy children previously immunized with 1 or 2 doses of Prevenar.
• Group 1: Male or female subjects between the age of >=140 and <=196 days of age at time of enrollment.
• Group 2: Male or female subjects between the age of >=336 and <=392 days of age at time of enrollment
• Available for entire study period.

Exclusion Criteria:

• Previous reaction or contra-indication to pneumococcal vaccine or vaccine related component.
• Previous vaccination with licensed or investigational pneumococcal vaccine other than Prevenar.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group 1	Biological: 13vPnC; 13vPnC will be administered by intramuscular injection at approximately 5 and 12 months of age.; Biological: 13vPnC; 13vPnC will be administered by intramuscular injection at approximately 12 months of age.
EXPERIMENTAL: Group 2	Biological: 13vPnC; 13vPnC will be administered by intramuscular injection at approximately 5 and 12 months of age.; Biological: 13vPnC; 13vPnC will be administered by intramuscular injection at approximately 12 months of age.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose	Antibody geometric mean concentration (GMC) as measured by micrograms per milliliter (mcg/mL) 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) were presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. GMCs were calculated using all participants with available data for the specified blood draw.	1 month after the toddler dose (13 months of age)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose	Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/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 infant series (6 months of age)
GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose	Antibody GMC 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) presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. GMCs calculated using all participants with available data for the specified blood draw.	1 Month after the infant series (6 months of age)
GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose	Antibody GMC 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) presented. GMC (13vPnC) and corresponding 2-sided 95% CIs evaluated. GMCs calculated using all participants with available data for the specified blood draw.	12 months of age (prior to toddler dose)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (5 Months of Age)	Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category.	Day 1 through Day 7 after vaccination
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age)	Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category.	Day 1 through Day 7 after vaccination
Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Infant Dose (5 Months of Age)	Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may have been represented in more than 1 category.	Day 1 through 7 after vaccination
Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Toddler Dose (12 Months of Age)	Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may have been represented in more than 1 category.	Day 1 through 7 after vaccination

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (ACTUAL): June 1, 2010
• Study Completion (ACTUAL): June 1, 2010

Study Registration Dates

• First Submitted: January 16, 2009
• First Submitted That Met QC Criteria: January 16, 2009
• First Posted (ESTIMATE): January 19, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): August 10, 2011
• Last Update Submitted That Met QC Criteria: August 4, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: Vaccines; Healthy Subjects; Pneumococcal
• Other Study ID Numbers: 6096A1-3012