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A Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) In Healthy Infants In China
Sponsor: Pfizer
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.
Official title: A Phase 3, Randomized, Active-controlled, Trial Evaluating The Safety, Tolerability, And Immunogenicity Of A 13vpnc Compared With A 7vpnc In Healthy Infants In China
Key Details
Gender
All
Age Range
42 Days - 77 Days
Study Type
INTERVENTIONAL
Enrollment
1674
Start Date
2012-09
Completion Date
2014-04
Last Updated
2026-06-02
Healthy Volunteers
Yes
Conditions
Interventions
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
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
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
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
Locations (4)
Jiangsu Province Guanyun County Center for Disease prevention and Control
Guanyun County,, Jiangsu, China
Jiangsu Province Huaiyin District Center for Disease prevention and Control
Huaian City,, Jiangsu, China
Jiangsu Province Hongze County Center for Disease prevention and Control
Huaian City, Jiangsu, China
Jiangsu Province Lianshui County Center for Disease prevention and Control
Lianshui County, Jiangsu, China