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A Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) In Healthy Infants In China

Last updated on March 22, 2018

FOR MORE INFORMATION
Study Location
Jiangsu Province Guanyun County Center for Disease prevention and Control
Guanyun County,, Jiangsu, 222200 China
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Infection
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
42-77 days
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Aged 42 to 77 days (approximately 2 months) at the time of enrollment.

2. Healthy infant as determined by medical history, physical examination, and judgment of
the investigator.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

1. Previous vaccination with licensed or investigational pneumococcal vaccine.

2. A previous anaphylactic reaction to any vaccine or vaccine-related component.

3. Contraindication to vaccination with pneumococcal vaccines.

NCT01692886
Pfizer
Completed
A Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) In Healthy Infants In China

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A Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) In Healthy Infants In China
A Phase 3, Randomized, Active-controlled Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13vPnC Vaccine Compared With a 7vPnC in Healthy Infants in China
This study is primarily designed to evaluate the IgG immune responses to the 13 pneumococcal serotypes induced by 13vPnC compared with the immune responses induced by 7vPnC when measured 1 month after the infant series, and to evaluate the acceptability of the safety profile of 13vPnC as measured by the incidence rates of local reactions, systemic events and adverse events.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Pneumococcal Infection
  • Biological: 7-valent Pneumococcal Conjugate Vaccine
    suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 4-Month Visit, 5-Month Visit, and 12-Month Visit, respectively
    Other Name: 7vPnC
  • Biological: 13-valent Pnumococcal Conjugate vaccine
    suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 4-Month Visit, 5-Month Visit, and 12-Month Visit, respectively
    Other Name: 13vPnC
  • Biological: 13-valent Pnumococcal Conjugate vaccine
    suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 2-Month Visit, 4-Month Visit, 6-Month Visit, and 12-Month Visit, respectively
    Other Name: 13vPnC
  • Biological: 13-valent Pnumococcal Conjugate vaccine
    suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 5-Month Visit, and 12-Month Visit, respectively
    Other Name: 13vPnC
  • Active Comparator: 7vPnC (3-, 4-, 5-, 12-Month)
    Intervention: Biological: 7-valent Pneumococcal Conjugate Vaccine
  • Experimental: 13vPnC (3-, 4-, 5-, 12-Month)
    Intervention: Biological: 13-valent Pnumococcal Conjugate vaccine
  • Experimental: 13vPnC (2-, 4-, 6-, 12-Month)
    Intervention: Biological: 13-valent Pnumococcal Conjugate vaccine
  • Experimental: 13vPnC (3-, 5-, 12-Month)
    Intervention: Biological: 13-valent Pnumococcal Conjugate vaccine
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1674
April 2014
April 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Aged 42 to 77 days (approximately 2 months) at the time of enrollment.
  2. Healthy infant as determined by medical history, physical examination, and judgment of the investigator.

Exclusion Criteria:

  1. Previous vaccination with licensed or investigational pneumococcal vaccine.
  2. A previous anaphylactic reaction to any vaccine or vaccine-related component.
  3. Contraindication to vaccination with pneumococcal vaccines.
Sexes Eligible for Study: All
42 Days to 77 Days   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01692886
B1851015
6096A1-3019
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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