Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Children

Pneumococcal Vaccines Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00824655
• Other study ID #: 6096A1-3012
• Status: Completed
• Phase: Phase 3
• First received: January 16, 2009
• Last updated: August 4, 2011
• Start date: March 2009
• Est. completion date: June 2010

Study information

• Verified date: August 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencySweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 140 Days to 392 Days

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pneumococcal Vaccines

Intervention

Biological:
• 13vPnC
13vPnC will be administered by intramuscular injection at approximately 5 and 12 months of age.
• 13vPnC
13vPnC will be administered by intramuscular injection at approximately 12 months of age.

Locations

Country	Name	City	State
Sweden	Pfizer Investigational Site	Eskilstuna
Sweden	Pfizer Investigational Site	Goteborg
Sweden	Pfizer Investigational Site	Malmo
Sweden	Pfizer Investigational Site	Orebro
Sweden	Pfizer Investigational Site	Ostersund
Sweden	Pfizer Investigational Site	Uddevalla
Sweden	Pfizer Investigational Site	Umea

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No

External Links

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