Clinical trial NCT01298544: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pneumococcal Disease
Keywords: Vaccine
Prevenar
Pneumococcal disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-02-17
Enrollment: 335
Sex: ALL
Minimum age (years): 4
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose
timeFrame: Day 1 (36 months after toddler dose)
Secondary outcomes:
Other outcomes:
measure: Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL, 36 Months After the Toddler Dose
timeFrame: Day 1 (36 months after toddler dose)
Locations:
city: Longan County
country: China
facility: Chengxiang Town Hospital
state: Guangxi
city: Longan County
country: China
facility: Longan County CDC
state: Guangxi
city: Longan County
country: China
facility: Nanyu Town Hospital
state: Guangxi
city: Longan County
country: China
facility: Yanjiang Town Hospital
state: Guangxi
city: Longan County
country: China
facility: Natong Town Hospital
state: Guangxi
city: Longan County
country: China
facility: Qiaojian Town Hospital
state: Guangxi
city: Longan County
country: China
facility: Gutan Village Hospital
state: Guangxi
city: Longan County
country: China
facility: Dingdang Town Hospital
state: Guangxi
city: Longan County
country: China
facility: Yangwan Hospital
state: Guangxi
city: Nanning
country: China
facility: GuangXi Center for Disease Prevention and Control
state: Guangxi
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
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.