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

Pneumococcal Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01298544
• Other study ID #: B1841009
• Secondary ID: 6114A1-4001
• Status: Completed
• Phase: Phase 4
• Start date: November 2010
• Est. completion date: March 2011

Study information

• Verified date: November 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 335
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pneumococcal Disease
• Pneumococcal Infections

Intervention

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

Locations

Country	Name	City	State
China	Chengxiang Town Hospital	Longan County	Guangxi
China	Dingdang Town Hospital	Longan County	Guangxi
China	Gutan Village Hospital	Longan County	Guangxi
China	Longan County CDC	Longan County	Guangxi
China	Nanyu Town Hospital	Longan County	Guangxi
China	Natong Town Hospital	Longan County	Guangxi
China	Qiaojian Town Hospital	Longan County	Guangxi
China	Yangwan Hospital	Longan County	Guangxi
China	Yanjiang Town Hospital	Longan County	Guangxi
China	GuangXi Center for Disease Prevention and Control	Nanning	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level =0.35 mcg/mL, 36 Months After the Toddler Dose	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.	Day 1 (36 months after toddler dose)
Primary	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)