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)
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01193582
First received: August 31, 2010
Last updated: October 12, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pneumococcal Infections |
Biological: Prevenar |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| 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. |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Antibody concentrations against the 7 pneumococcal serotypes contained in Prevenar [ Time Frame: 1 month after last dose ] [ Designated as safety issue: No ]
- Antibody concentrations against the 7 pneumococcal serotypes contained in Prevenar [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Antibody concentrations against the 7 pneumococcal serotypes contained in Prevenar [ Time Frame: 1 month after third dose of Prevenar in Group 1 ] [ Designated as safety issue: No ]
- Antibody concentrations against the 7 pneumococcal serotypes contained in Prevenar [ Time Frame: 1 month after second dose of Prevenar in Group 2 ] [ Designated as safety issue: No ]
- Antibody concentrations against the 7 pneumococcal serotypes contained in Prevenar [ Time Frame: 1 month after first dose of Prevenar in Group 3 ] [ Designated as safety issue: No ]
- Summary of adverse events and serious adverse events [ Time Frame: Baseline through 12 months following last dose of Prevenar ] [ Designated as safety issue: Yes ]
| Enrollment: | 505 |
| Study Start Date: | September 2010 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Group 1 |
Biological: Prevenar
Dosage form: intramuscular injection Dosage: 0.5 ml Frequency: 4 doses starting from 121 to < 212 days of age |
| Experimental: Group 2 |
Biological: Prevenar
Dosage form: intramuscular injection Dosage: 0.5 ml Frequency: 3 doses starting from 212 days to < 12 months of age |
| Experimental: Group 3 |
Biological: Prevenar
Dosage form: intramuscular injection Dosage: 0.5 ml Frequency: 2 doses starting from 12 months to < 24 months of age |
| Experimental: Group 4 |
Biological: Prevenar
Dosage form: intramuscular injection Dosage: 0.5 ml Frequency: 1 dose starting from 24 months to < 72 months of age |
Eligibility| Ages Eligible for Study: | 121 Days to 72 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01193582
Locations
| China, Guangxi | |
| Baolixiang Clinic | |
| Baoli Town,Yongfu County, Guangxi, China, 541902 | |
| Guangfuxiang Clinic | |
| Guangfu Town, Yongfu County, Guangxi, China, 541803 | |
| Luojin Clinic | |
| Luojin Town, Yongfu County, Guangxi, China, 541801 | |
| Yongfu County CDC | |
| Yongfu County, Guangxi, China, 541800 | |
| Yongfu County Clinic | |
| Yongfu County, Guangxi, China, 541800 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01193582 History of Changes |
| Other Study ID Numbers: | B1841008, B1841008 |
| Study First Received: | August 31, 2010 |
| Last Updated: | October 12, 2012 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Pfizer:
|
Prevenar catch-up pneumococcal pneumonia |
Additional relevant MeSH terms:
|
Pneumococcal Infections Streptococcal Infections Gram-Positive Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on May 23, 2013