Clinical trial NCT00824655: Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Children
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Vaccines
Keywords: Healthy Subjects
Vaccines
Pneumococcal
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-01-19
Enrollment: 234
Sex: ALL
Minimum age (years): 140
Maximum age (years): 392
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose
timeFrame: 1 month after the toddler dose (13 months of age)
Secondary outcomes:
measure: Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose
timeFrame: 1 Month after the infant series (6 months of age)
measure: GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose
timeFrame: 1 Month after the infant series (6 months of age)
measure: GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose
timeFrame: 12 months of age (prior to toddler dose)
Other outcomes:
measure: Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (5 Months of Age)
timeFrame: Day 1 through Day 7 after vaccination
measure: Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age)
timeFrame: Day 1 through Day 7 after vaccination
measure: Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Infant Dose (5 Months of Age)
timeFrame: Day 1 through 7 after vaccination
measure: Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Toddler Dose (12 Months of Age)
timeFrame: Day 1 through 7 after vaccination
Locations:
city: Eskilstuna
country: Sweden
facility: Pfizer Investigational Site
city: Goteborg
country: Sweden
facility: Pfizer Investigational Site
city: Malmo
country: Sweden
facility: Pfizer Investigational Site
city: Orebro
country: Sweden
facility: Pfizer Investigational Site
city: Ostersund
country: Sweden
facility: Pfizer Investigational Site
city: Uddevalla
country: Sweden
facility: Pfizer Investigational Site
city: Umea
country: Sweden
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: