A Study To Assess The Safety And Effectiveness Of Prevenar In Chinese Children Who Have Not Previously Received A Vaccine Against Pneumococcal Bacteria

NCT01193582 | Completed Phase 4 Results

• 1 other identifier: B1841008
• Study Type: interventional
• Target: 505
• Locations: 1 country
• Sites: 5

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.

Conditions

Pneumococcal Infections

Keywords

Prevenar; catch-up; pneumococcal; pneumonia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Third Dose in Group 1

  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.

  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

  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.

  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

  1 month after first dose of Prevenar in Group 3

Study Arms (4)

Group 1

EXPERIMENTAL

Biological: Prevenar

Group 2

EXPERIMENTAL

Biological: Prevenar

Group 3

EXPERIMENTAL

Biological: Prevenar

Group 4

EXPERIMENTAL

Biological: Prevenar

Interventions

Prevenar BIOLOGICAL

Dosage form: intramuscular injection Dosage: 0.5 ml Frequency: 4 doses starting from 121 to \< 212 days of age

Group 1

Eligibility Criteria

• Age: 121 Days - 72 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (5)

Baolixiang Clinic

Baoli Town,Yongfu County, Guangxi, 541902, China

Location

Guangfuxiang Clinic

Guangfu Town, Yongfu County, Guangxi, 541803, China

Location

Luojin Clinic

Luojin Town, Yongfu County, Guangxi, 541801, China

Location

Yongfu County CDC

Yongfu County, Guangxi, 541800, China

Location

Yongfu County Clinic

Yongfu County, Guangxi, 541800, China

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Pneumococcal Infections; Pneumonia

Interventions

Heptavalent Pneumococcal Conjugate Vaccine

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pneumococcal Vaccines; Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2010
• First Posted: September 2, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: November 20, 2013
• Results First Posted: November 20, 2013

Record last verified: 2013-09

Locations

CN (5)