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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

NCT ID: NCT01298544

Last Updated: 2018-12-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

335 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pneumococcal Disease

Keywords

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Vaccine Prevenar Pneumococcal disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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All subjects

Group Type OTHER

Blood draw

Intervention Type PROCEDURE

One 5mL blood draw for immunogenicity at least 3 years post completion of clinical study 0887X-101518.

Interventions

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Blood draw

One 5mL blood draw for immunogenicity at least 3 years post completion of clinical study 0887X-101518.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Chengxiang Town Hospital

Longan County, Guangxi, China

Site Status

Longan County CDC

Longan County, Guangxi, China

Site Status

Nanyu Town Hospital

Longan County, Guangxi, China

Site Status

Yanjiang Town Hospital

Longan County, Guangxi, China

Site Status

Natong Town Hospital

Longan County, Guangxi, China

Site Status

Qiaojian Town Hospital

Longan County, Guangxi, China

Site Status

Gutan Village Hospital

Longan County, Guangxi, China

Site Status

Dingdang Town Hospital

Longan County, Guangxi, China

Site Status

Yangwan Hospital

Longan County, Guangxi, China

Site Status

GuangXi Center for Disease Prevention and Control

Nanning, Guangxi, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 27616471 (View on PubMed)

Other Identifiers

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6114A1-4001

Identifier Type: -

Identifier Source: secondary_id

B1841009

Identifier Type: -

Identifier Source: org_study_id