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COMPLETED
NCT01692886
PHASE3

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

Sponsor: Pfizer

View on ClinicalTrials.gov

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

Interventions

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

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

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

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

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