A Study To Assess The Safety And Effectiveness Of Prevenar In Chinese Children Who Have Not Previously Received A Vaccine Against Pneumococcal Bacteria (6114A1-4000-CN)

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.

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.

Study Overview

• Status: Completed
• Conditions: Pneumococcal Infections
• Intervention / Treatment: Biological: Prevenar; Biological: Prevenar; Biological: Prevenar; Biological: Prevenar

• Study Type: Interventional
• Enrollment (Actual): 505
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangxi
    • Baoli Town,Yongfu County, Guangxi, China, 541902
      • Baolixiang Clinic
    • Guangfu Town, Yongfu County, Guangxi, China, 541803
      • Guangfuxiang Clinic
    • Luojin Town, Yongfu County, Guangxi, China, 541801
      • Luojin Clinic
    • Yongfu County, Guangxi, China, 541800
      • Yongfu County CDC
    • Yongfu County, Guangxi, China, 541800
      • Yongfu County Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 2	Biological: Prevenar; Dosage form: intramuscular injection Dosage: 0.5 ml Frequency: 4 doses starting from 121 to < 212 days of age; Biological: Prevenar; Dosage form: intramuscular injection Dosage: 0.5 ml Frequency: 3 doses starting from 212 days to < 12 months of age; Biological: Prevenar; Dosage form: intramuscular injection Dosage: 0.5 ml Frequency: 2 doses starting from 12 months to < 24 months of age; Biological: Prevenar; Dosage form: intramuscular injection Dosage: 0.5 ml Frequency: 1 dose starting from 24 months to < 72 months of age
Experimental: Group 1	Biological: Prevenar; Dosage form: intramuscular injection Dosage: 0.5 ml Frequency: 4 doses starting from 121 to < 212 days of age; Biological: Prevenar; Dosage form: intramuscular injection Dosage: 0.5 ml Frequency: 3 doses starting from 212 days to < 12 months of age; Biological: Prevenar; Dosage form: intramuscular injection Dosage: 0.5 ml Frequency: 2 doses starting from 12 months to < 24 months of age; Biological: Prevenar; Dosage form: intramuscular injection Dosage: 0.5 ml Frequency: 1 dose starting from 24 months to < 72 months of age
Experimental: Group 3	Biological: Prevenar; Dosage form: intramuscular injection Dosage: 0.5 ml Frequency: 4 doses starting from 121 to < 212 days of age; Biological: Prevenar; Dosage form: intramuscular injection Dosage: 0.5 ml Frequency: 3 doses starting from 212 days to < 12 months of age; Biological: Prevenar; Dosage form: intramuscular injection Dosage: 0.5 ml Frequency: 2 doses starting from 12 months to < 24 months of age; Biological: Prevenar; Dosage form: intramuscular injection Dosage: 0.5 ml Frequency: 1 dose starting from 24 months to < 72 months of age
Experimental: Group 4	Biological: Prevenar; Dosage form: intramuscular injection Dosage: 0.5 ml Frequency: 4 doses starting from 121 to < 212 days of age; Biological: Prevenar; Dosage form: intramuscular injection Dosage: 0.5 ml Frequency: 3 doses starting from 212 days to < 12 months of age; Biological: Prevenar; Dosage form: intramuscular injection Dosage: 0.5 ml Frequency: 2 doses starting from 12 months to < 24 months of age; Biological: Prevenar; Dosage form: intramuscular injection Dosage: 0.5 ml Frequency: 1 dose starting from 24 months to < 72 months of age

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar	Serotype-specific Pneumococcal Immunoglobulin G (IgG) antibody geometric mean concentration (GMC) after 1 month of last dose for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.	1 month after last dose in each group
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each Group	Serotype-specific Pneumococcal IgG antibody GMC at baseline for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Third Dose in Group 1	Serotype-specific Pneumococcal IgG antibody GMC one month after the third dose in Group 1 for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.	1 month after third dose of Prevenar in Group 1
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.	GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers.	Pre-vaccination to 1 month after third dose of Prevenar in Group 1
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Second Dose in Group 2	Serotype-specific Pneumococcal IgG antibody GMC 1 month after the second dose in Group 2 for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.	1 month after second dose of Prevenar in Group 2
GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 2.	GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers.	Pre-vaccination to 1 month after second dose of Prevenar in Group 2
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the First Dose in Group 3	Serotype-specific Pneumococcal IgG antibody GMC one month after the first dose in Group 3 for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.	1 month after first dose of Prevenar in Group 3
GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 3.	GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers.	Pre-vaccination to 1 month after first dose of Prevenar in Group 3
Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.	Serotype-specific Pneumococcal IgG antibody GMC 12 months after the last dose for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.	12 months after the last dose
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.	GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to 12- month follow-up were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers.	Pre-vaccination to 12 months after the last dose

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: September 1, 2010
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: August 31, 2010
• First Submitted That Met QC Criteria: August 31, 2010
• First Posted (Estimate): September 2, 2010

Study Record Updates

• Last Update Posted (Estimate): November 20, 2013
• Last Update Submitted That Met QC Criteria: September 17, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: pneumonia; pneumococcal; Prevenar; catch-up
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumococcal Infections; Physiological Effects of Drugs; Immunologic Factors; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: B1841008