Study Evaluating Antibody Response Of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) 24 Months After Toddler Dose.

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Pfizer

Status and phase

Completed
Phase 3

Conditions

Immunization
Antibody Response
13-valent Pneumococcal Vaccine
Safety

Treatments

Biological: 13-valent pneumococcal conjugate vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01026038
6096A1-3021
B1851016

Details and patient eligibility

About

This is an open-label study (a study in which the doctors and participants know which drug or vaccine is being administered) in children who previously received a 4-dose series of a pneumococcal conjugate vaccine (PnC) during infancy in Study 6096A1-008-EU (NCT00366678). In this study, participants will receive an additional dose of 13-valent pneumococcal conjugate vaccine. The purpose of this study is to evaluate persistence, if any, of the antibody response by measuring any remaining pneumococcal antibodies since the previous study. This study will also evaluate the safety and immunogenicity of 13-valent pneumococcal conjugate vaccine when administered at least 24 months after the last dose of pneumococcal conjugate vaccine.

Enrollment

263 patients

Sex

All

Ages

3+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy subjects at least 3 years of age, who received all 4 assigned doses of pneumococcal conjugate vaccine and completed Study 6096A1-008-EU (NCT00366678) for at least 24 months

Exclusion criteria

  • Vaccination with any licensed or investigational pneumococcal vaccine since completion of Study 6096A1-008-EU(NCT00366678).
  • History of culture-proven invasive disease caused by S pneumoniae since the completion of Study 6096A1-008-EU (NCT00366678).
  • Previous anaphylactic reaction to any vaccine or vaccine-related component.
  • Contraindication to vaccination

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

263 participants in 1 patient group

1
Experimental group
Description:
1 dose (0.5 mL), IM of 13vPnC vaccine.
Treatment:
Biological: 13-valent pneumococcal conjugate vaccine

Trial contacts and locations

25

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Data sourced from clinicaltrials.gov

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