Study Evaluating Antibody Response Of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) 24 Months After Toddler Dose.
NCT01026038
Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
13-valent Pneumococcal Vaccine, Immunization, Safety, Antibody Response
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
3 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- 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
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13-valent Pneumococcal Vaccine, Immunization, Safety, Antibody ResponseStudy Evaluating Antibody Response Of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) 24 Months After Toddler Dose.
NCT01026038
- Ancenis,
- Bondues,
- Brest,
- Chalons En Champagne,
- Draguignan,
- Ecully,
- Essey Les Nancy,
- Floirac,
- Garges Les Gonesses,
- Joue Les Tours,
- Le Havre,
- Lingolsheim,
- Lyon,
- Maromme,
- Moutiers,
- Nancy,
- Nice,
- Olonne Sur Mer,
- Strasbourg,
- Strasbourg,
- Talence,
- Thionville,
- Tours,
- Villers Les Nancy,
- Vitry Sur Seine,
ALL GENDERS
3 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Study Evaluating Antibody Response Of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) 24 Months After Toddler Dose. | |||
| Official Title ICMJE | 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 | |||
| 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 3 | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Prevention | |||
| Condition ICMJE |
| |||
| Intervention ICMJE | Biological: 13-valent pneumococcal conjugate vaccine
All subjects will receive 1 dose (0.5 mL), IM of 13vPnC vaccine. (at least 24 months after toddler dose). | |||
| Study Arms ICMJE | Experimental: 1
1 dose (0.5 mL), IM of 13vPnC vaccine. Intervention: Biological: 13-valent pneumococcal conjugate vaccine | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 263 | |||
| Original Estimated Enrollment ICMJE | 500 | |||
| Actual Study Completion Date ICMJE | November 2010 | |||
| Actual Primary Completion Date | November 2010 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 3 Years and older (Child, Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | Yes | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | France | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01026038 | |||
| Other Study ID Numbers ICMJE | 6096A1-3021 B1851016 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | January 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||