A Study to Evaluate the Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine (PCV13i) in Healthy Infants Aged 2 Months (Minimum 6 Weeks)

Recruiting Phase 3 Interventional Study
Pneumococcal Infections Streptococcal Infections Bacterial Infections
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
6 Weeks – 2 Months
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
600 (estimated)
Sponsor
CanSino Biologics Inc. · Industry
Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
About This Trial
This is a Phase 3 randomized, observation-blinded, active-controlled, parallel-group clinical trial designed to evaluate the immunogenicity, safety, and functional antibody response of the experimental vaccine versus the control vaccine in healthy Thailand infants vaccinated at a 2+1 schedule (2 months, 4 months and 12-15 months). The trial will enroll approximately 600 healthy infants aged 2 mont…
Trial Locations
Loading…

Loading trial locations…

Eligibility Criteria
Inclusion Criteria: * Healthy infants with stable clinical conditions aged 2 months (42-90 days) at the time of screening, based on medical history and clinical assessment by the investigator. Infants will be eligible starting from the day they turn 6 weeks of age. * Infant's parent or legal guardi…
Contacts

Meixu Yan

022-58213600-6051

meixu.yan@cansinotech.com

CONTACT

Lina Wang

022-58213600-6051

lina.wang@cansinotech.com

CONTACT