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A Study to Assess the Antibody Response of Healthy Chinese Children Who Have Been Vaccinated Previously With 4-doses of Prevenar (a Pneumococcal Vaccine) as Babies and Toddlers

Primary Purpose

Pneumococcal Disease

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Blood draw
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumococcal Disease focused on measuring Vaccine, Prevenar, Pneumococcal disease

Eligibility Criteria

4 Years - 5 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Male or female subjects who participated in and completed Wyeth study 0887X 101518.
  • Healthy subject as determined by medical history, physical examination, and judgment of the investigator.

Exclusion Criteria:

  • Vaccination with any licensed or investigational pneumococcal vaccine since completion of Wyeth study 0887X 101518.
  • History of culture proven invasive disease caused by S pneumoniae since the completion of Wyeth study 0887X 101518.
  • Known or suspected immune deficiency or suppression since participation in Wyeth study 0887X 101518.

Sites / Locations

  • Chengxiang Town Hospital
  • Longan County CDC
  • Nanyu Town Hospital
  • Yanjiang Town Hospital
  • Natong Town Hospital
  • Qiaojian Town Hospital
  • Gutan Village Hospital
  • Dingdang Town Hospital
  • Yangwan Hospital
  • GuangXi Center for Disease Prevention and Control

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

All subjects

Arm Description

Outcomes

Primary Outcome Measures

Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose
Antibody geometric mean concentration (GMC) as measured by mcg/mL for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F). GMC (7vPnC, 7vPnC/DTaP, and DTap) 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.

Secondary Outcome Measures

Full Information

First Posted
November 29, 2010
Last Updated
November 30, 2018
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01298544
Brief Title
A Study to Assess the Antibody Response of Healthy Chinese Children Who Have Been Vaccinated Previously With 4-doses of Prevenar (a Pneumococcal Vaccine) as Babies and Toddlers
Official Title
A Phase 4, Open-label Study to Evaluate Persistence of the Antibody Response Elicited by Prevenar in Healthy Children in China Who Have Been Previously Immunized With a 4-dose Series of a Pneumococcal Conjugate Vaccine During Infancy in Study 0887x-101518
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In 2005, Wyeth conducted study 0887X-101518 (NCT00488826) in which Chinese infants received either Prevenar alone (Group 1), Prevenar given with a Diphtheria, Tetanus and acellular Pertussis (DTaP) vaccine (Group 2) or DTaP alone (Group 3). This follow up study (at least 3 years after the last vaccination) will assess the antibody concentrations in children who previously completed Wyeth study 0887X-101518.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Disease
Keywords
Vaccine, Prevenar, Pneumococcal disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
335 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All subjects
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Blood draw
Intervention Description
One 5mL blood draw for immunogenicity at least 3 years post completion of clinical study 0887X-101518.
Primary Outcome Measure Information:
Title
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose
Description
Antibody geometric mean concentration (GMC) as measured by mcg/mL for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F). GMC (7vPnC, 7vPnC/DTaP, and DTap) 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.
Time Frame
Day 1 (36 months after toddler dose)
Other Pre-specified Outcome Measures:
Title
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL, 36 Months After the Toddler Dose
Description
Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F). Exact 2-sided CI based on the observed proportion of participants.
Time Frame
Day 1 (36 months after toddler dose)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male or female subjects who participated in and completed Wyeth study 0887X 101518. Healthy subject as determined by medical history, physical examination, and judgment of the investigator. Exclusion Criteria: Vaccination with any licensed or investigational pneumococcal vaccine since completion of Wyeth study 0887X 101518. History of culture proven invasive disease caused by S pneumoniae since the completion of Wyeth study 0887X 101518. Known or suspected immune deficiency or suppression since participation in Wyeth study 0887X 101518.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Chengxiang Town Hospital
City
Longan County
State/Province
Guangxi
ZIP/Postal Code
532700
Country
China
Facility Name
Longan County CDC
City
Longan County
State/Province
Guangxi
ZIP/Postal Code
532700
Country
China
Facility Name
Nanyu Town Hospital
City
Longan County
State/Province
Guangxi
ZIP/Postal Code
532701
Country
China
Facility Name
Yanjiang Town Hospital
City
Longan County
State/Province
Guangxi
ZIP/Postal Code
532702
Country
China
Facility Name
Natong Town Hospital
City
Longan County
State/Province
Guangxi
ZIP/Postal Code
532703
Country
China
Facility Name
Qiaojian Town Hospital
City
Longan County
State/Province
Guangxi
ZIP/Postal Code
532707
Country
China
Facility Name
Gutan Village Hospital
City
Longan County
State/Province
Guangxi
ZIP/Postal Code
532708
Country
China
Facility Name
Dingdang Town Hospital
City
Longan County
State/Province
Guangxi
ZIP/Postal Code
532709
Country
China
Facility Name
Yangwan Hospital
City
Longan County
State/Province
Guangxi
ZIP/Postal Code
532715
Country
China
Facility Name
GuangXi Center for Disease Prevention and Control
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530028
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
27616471
Citation
Li R, Fang KX, Young M Jr, Zhou X, Chen Z, Liang JZ, Giardina PC, Scott DA. Long-term antibody persistence study (3 years after last dose) of the 7-valent pneumococcal conjugate vaccine in young children in China. Vaccine. 2016 Oct 17;34(44):5359-5365. doi: 10.1016/j.vaccine.2016.08.070. Epub 2016 Sep 8.
Results Reference
derived

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A Study to Assess the Antibody Response of Healthy Chinese Children Who Have Been Vaccinated Previously With 4-doses of Prevenar (a Pneumococcal Vaccine) as Babies and Toddlers

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