Clinical trial NCT01193582: A Study To Assess The Safety And Effectiveness Of Prevenar In Chinese Children Who Have Not Previously Received A Vaccine Against Pneumococcal Bacteria
Official title: A Phase 4, Open-label Trial to Assess the Safety, Tolerability and Immunogenicity of Prevenar in Older Infants and Young Children in China Who Are Naive to Previous Pneumococcal Vaccination.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pneumococcal Infections
Keywords: Prevenar
catch-up
pneumococcal
pneumonia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-09-02
Enrollment: 505
Sex: ALL
Minimum age (years): 121
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: A vaccine called Prevenar is already approved for use in China for vaccination of children younger than 6 years old against infections caused by Streptococcus pneumoniae.

This study is to measure the amount of antibodies (antibodies help people fight off diseases) Chinese children aged between 121 days and 6 years (72 months) produce when given Prevenar. The study will also provide more data on how safe and well tolerated Prevenar is in Chinese children.


Eligibility criteria: Inclusion Criteria:

* Healthy Chinese male or female subjects.
* Between 121 days to less than 72 months of age at the time of entry into the study.

Exclusion Criteria:

* Receipt of previous vaccine against Pneumo
* Previous anaphylactic reaction to any vaccine or part of a vaccine
* Previous proven invasive Pneumo infection
* Receipt of investigational drug or device within the proceeding 28 days

Primary outcomes:
measure: Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar
timeFrame: 1 month after last dose in each group
measure: Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each Group
timeFrame: Baseline
Secondary outcomes:
measure: Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Third Dose in Group 1
timeFrame: 1 month after third dose of Prevenar in Group 1
measure: Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 1.
timeFrame: Pre-vaccination to 1 month after third dose of Prevenar in Group 1
measure: Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Second Dose in Group 2
timeFrame: 1 month after second dose of Prevenar in Group 2
measure: GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 2.
timeFrame: Pre-vaccination to 1 month after second dose of Prevenar in Group 2
measure: Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the First Dose in Group 3
timeFrame: 1 month after first dose of Prevenar in Group 3
measure: GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 3.
timeFrame: Pre-vaccination to 1 month after first dose of Prevenar in Group 3
measure: Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.
timeFrame: 12 months after the last dose
measure: GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.
timeFrame: Pre-vaccination to 12 months after the last dose
Other outcomes:
Locations:
city: Baoli Town,Yongfu County
country: China
facility: Baolixiang Clinic
state: Guangxi
city: Guangfu Town, Yongfu County
country: China
facility: Guangfuxiang Clinic
state: Guangxi
city: Luojin Town, Yongfu County
country: China
facility: Luojin Clinic
state: Guangxi
city: Yongfu County
country: China
facility: Yongfu County CDC
state: Guangxi
city: Yongfu County
country: China
facility: Yongfu County Clinic
state: Guangxi
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: