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

CompletedPhase 3

Sponsor: Pfizer

Conditions: Pneumococcal Infection

Interventions: 7-valent Pneumococcal Conjugate Vaccine, 13-valent Pnumococcal Conjugate vaccine, 13-valent Pnumococcal Conjugate vaccine, 13-valent Pnumococcal Conjugate vaccine

Countries: 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.

Eligibility overview

Sex: ALL

Age: 42 Days to 77 Days

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (4)

Guanyun County,, Jiangsu, China
Huaian City,, Jiangsu, China
Huaian City, Jiangsu, China
Lianshui County, Jiangsu, China