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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1674 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study Assessing 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Infants and Young Children

NCT03574389

Pneumococcal Infections Pneumococcal Conjugate Vaccine

COMPLETED PHASE3

Study Evaluating 7-Valent Pneumococcal Conjugate Vaccine in Healthy Infants

NCT00488826

Pneumococcal Infections

COMPLETED PHASE1

Study Evaluating Pneumococcal Vaccine in Healthy Infants

NCT00205803

Healthy Subjects Pneumococcal Infections

COMPLETED PHASE1/PHASE2

Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered to Infants in Taiwan

NCT00688870

Vaccines Pneumococcal Conjugate Vaccine

COMPLETED PHASE3

A Phase III Clinical Trial of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants

NCT02494999

Pneumonia

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pneumococcal Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

7-valent Pneumococcal Conjugate Vaccine

Intervention Type BIOLOGICAL

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

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

Group Type EXPERIMENTAL

13-valent Pnumococcal Conjugate vaccine

Intervention Type BIOLOGICAL

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

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

Group Type EXPERIMENTAL

13-valent Pnumococcal Conjugate vaccine

Intervention Type BIOLOGICAL

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

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

Group Type EXPERIMENTAL

13-valent Pnumococcal Conjugate vaccine

Intervention Type BIOLOGICAL

suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 5-Month Visit, and 12-Month Visit, respectively

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

7vPnC 13vPnC 13vPnC 13vPnC

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

42 Days

Maximum Eligible Age

77 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes