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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Pneumococcal Infection

Treatments: Biological: 13-valent Pnumococcal Conjugate vaccine; Biological: 7-valent Pneumococcal Conjugate Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01692886

6096A1-3019

B1851015

Details and patient eligibility

About

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.

Enrollment: 1,674 patients

Sex: All

Ages: 42 to 77 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,674 participants in 4 patient groups

7vPnC (3-, 4-, 5-, 12-Month)

Active Comparator group

Treatment:

Biological: 7-valent Pneumococcal Conjugate Vaccine

13vPnC (3-, 4-, 5-, 12-Month)

Experimental group

Treatment:

Biological: 13-valent Pnumococcal Conjugate vaccine

Biological: 13-valent Pnumococcal Conjugate vaccine

Biological: 13-valent Pnumococcal Conjugate vaccine

13vPnC (2-, 4-, 6-, 12-Month)

Experimental group

Treatment:

Biological: 13-valent Pnumococcal Conjugate vaccine

Biological: 13-valent Pnumococcal Conjugate vaccine

Biological: 13-valent Pnumococcal Conjugate vaccine

13vPnC (3-, 5-, 12-Month)

Experimental group

Treatment:

Biological: 13-valent Pnumococcal Conjugate vaccine

Biological: 13-valent Pnumococcal Conjugate vaccine

Biological: 13-valent Pnumococcal Conjugate vaccine