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
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
2 other identifiers
interventional
335
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2010
Shorter than P25 for phase_4
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 29, 2010
CompletedFirst Posted
Study publicly available on registry
February 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedResults Posted
Study results publicly available
March 16, 2012
CompletedDecember 19, 2018
November 1, 2018
4 months
November 29, 2010
February 13, 2012
November 30, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Day 1 (36 months after toddler dose)
Other Outcomes (1)
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL, 36 Months After the Toddler Dose
Day 1 (36 months after toddler dose)
Study Arms (1)
All subjects
OTHERInterventions
One 5mL blood draw for immunogenicity at least 3 years post completion of clinical study 0887X-101518.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (10)
Chengxiang Town Hospital
Longan County, Guangxi, 532700, China
Longan County CDC
Longan County, Guangxi, 532700, China
Nanyu Town Hospital
Longan County, Guangxi, 532701, China
Yanjiang Town Hospital
Longan County, Guangxi, 532702, China
Natong Town Hospital
Longan County, Guangxi, 532703, China
Qiaojian Town Hospital
Longan County, Guangxi, 532707, China
Gutan Village Hospital
Longan County, Guangxi, 532708, China
Dingdang Town Hospital
Longan County, Guangxi, 532709, China
Yangwan Hospital
Longan County, Guangxi, 532715, China
GuangXi Center for Disease Prevention and Control
Nanning, Guangxi, 530028, China
Related Publications (1)
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.
PMID: 27616471DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
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
November 29, 2010
First Posted
February 17, 2011
Study Start
November 1, 2010
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
December 19, 2018
Results First Posted
March 16, 2012
Record last verified: 2018-11