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

NCT01692886

Last updated date
Study Location
Jiangsu Province Guanyun County Center for Disease prevention and Control
Guanyun County,, Jiangsu, 222200, China
Contact
1-800-718-1021

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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.

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Pneumococcal InfectionA Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) In Healthy Infants In China
NCT01692886
  1. Guanyun County,, Jiangsu
  2. Huaian City, Jiangsu
  3. Huaian City, Jiangsu
  4. Lianshui County, Jiangsu
ALL GENDERS
42 Days+
years
MULTIPLE SITES
Pneumococcal InfectionA Study Assessing 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Subjects
NCT01531322
  1. Huaian, Jiangsu
  2. Nanjing, Jiangsu
ALL GENDERS
42 Days+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) In Healthy Infants In China
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Pneumococcal Infection
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 15, 2013)
1674
Original Estimated Enrollment  ICMJE
 (submitted: September 21, 2012)
1666
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 42 Days to 77 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01692886
Other Study ID Numbers  ICMJE B1851015
6096A1-3019
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP