Clinical trial NCT01026038: Study Evaluating Antibody Response Of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) 24 Months After Toddler Dose.
Official title: A Phase 3, Open-label Study to Evaluate Persistence of the Antibody Response Elicited by Pneumococcal Conjugate Vaccine in Healthy Children Who Have Been Previously Immunized With a 4-Dose Series of a Pneumococcal Conjugate Vaccine During Infancy in Study 6096A1-008-EU and the Safety and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine Administered at Least 24 Months After the Last Toddler Dose of Pneumococcal Conjugate Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: 13-valent Pneumococcal Vaccine
Immunization
Safety
Antibody Response
Keywords: Pneumococcal vaccine 13-valent
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-12-04
Enrollment: 263
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is an open-label study (a study in which the doctors and participants know which drug or vaccine is being administered) in children who previously received a 4-dose series of a pneumococcal conjugate vaccine (PnC) during infancy in Study 6096A1-008-EU (NCT00366678). In this study, participants will receive an additional dose of 13-valent pneumococcal conjugate vaccine. The purpose of this study is to evaluate persistence, if any, of the antibody response by measuring any remaining pneumococcal antibodies since the previous study. This study will also evaluate the safety and immunogenicity of 13-valent pneumococcal conjugate vaccine when administered at least 24 months after the last dose of pneumococcal conjugate vaccine.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects at least 3 years of age, who received all 4 assigned doses of pneumococcal conjugate vaccine and completed Study 6096A1-008-EU (NCT00366678) for at least 24 months

Exclusion Criteria:

* Vaccination with any licensed or investigational pneumococcal vaccine since completion of Study 6096A1-008-EU(NCT00366678).
* History of culture-proven invasive disease caused by S pneumoniae since the completion of Study 6096A1-008-EU (NCT00366678).
* Previous anaphylactic reaction to any vaccine or vaccine-related component.
* Contraindication to vaccination

Primary outcomes:
measure: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine
timeFrame: One month after vaccination
measure: Percentage of Participants With Prespecified Local Reactions
timeFrame: Seven days after vaccination
measure: Percentage of Participants With Prespecified Systemic Events
timeFrame: Seven days after vaccination
Secondary outcomes:
measure: Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine
timeFrame: Up to 7 days before vaccination
measure: Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine
timeFrame: Four to seven days after vaccination
measure: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine
timeFrame: Up to 7 days before vaccination
measure: Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine
timeFrame: One month after vaccination
measure: Percentage of Participants With at Least 1/8 Serotype-specific OPA GMTs After Single Dose of 13vPnC Vaccine
timeFrame: One month after vaccination
measure: Percentage of Participants With at Least 1/2048 OPA GMTs for Serotype 7F After Single Dose of 13vPnC Vaccine
timeFrame: One month after vaccination
Other outcomes:
Locations:
city: Ancenis
country: France
facility: Pfizer Investigational Site
city: Bondues
country: France
facility: Pfizer Investigational Site
city: Brest
country: France
facility: Pfizer Investigational Site
city: Chalons En Champagne
country: France
facility: Pfizer Investigational Site
city: Draguignan
country: France
facility: Pfizer Investigational Site
city: Ecully
country: France
facility: Pfizer Investigational Site
city: Essey Les Nancy
country: France
facility: Pfizer Investigational Site
city: Floirac
country: France
facility: Pfizer Investigational Site
city: Garges Les Gonesses
country: France
facility: Pfizer Investigational Site
city: Joue Les Tours
country: France
facility: Pfizer Investigational Site
city: Le Havre
country: France
facility: Pfizer Investigational Site
city: Lingolsheim
country: France
facility: Pfizer Investigational Site
city: Lyon
country: France
facility: Pfizer Investigational Site
city: Maromme
country: France
facility: Pfizer Investigational Site
city: Moutiers
country: France
facility: Pfizer Investigational Site
city: Nancy
country: France
facility: Pfizer Investigational Site
city: Nice
country: France
facility: Pfizer Investigational Site
city: Olonne Sur Mer
country: France
facility: Pfizer Investigational Site
city: Strasbourg
country: France
facility: Pfizer Investigational Site
city: Strasbourg
country: France
facility: Pfizer Investigational Site
city: Talence
country: France
facility: Pfizer Investigational Site
city: Thionville
country: France
facility: Pfizer Investigational Site
city: Tours
country: France
facility: Pfizer Investigational Site
city: Villers Les Nancy
country: France
facility: Pfizer Investigational Site
city: Vitry Sur Seine
country: France
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: