Health TrialsbyHealthPanel

Clinical Trial of PCV24 in Infants Aged 2-23 Months

ConditionPneumococcal Infectious Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age42-23
SponsorSinovac Life Sciences Co., Ltd.

About this trial

A Phase 1b clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in pediatric population aged 2 months (minimum 42 days)-23 months.

The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV24. The trial is a randomized, double-blind, positive controlled phase Ib clinical trial.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy infants who are aged 2 months (42-89 days), 7-11 months, 12-23 months;

Participants' guardian provides legal identity document and participants' vaccination record;

Participants' guardian understands and voluntarily signs the informed consent form;

Follow all study procedures and stay in contact during the study.

Disqualifiers

Received any pneumococcal vaccine prior to enrollment;

History of invasive pneumococcal diseases or other pneumococcal diseases caused by Streptococcus pneumoniae, as confirmed by laboratory tests;

History of severe adverse reactions to the vaccine or vaccine components, or history of allergy, such as urticaria, dyspnea, angioneurotic edema, anaphylactic shock;

Low birth weight (<2.5kg), or premature infant (gestation weeks < 37 weeks) (applies to infants younger than 12 months);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sinovac PCV24

    Biological/Vaccine

    Sinovac PCV24 (0.5 mL) is administered intramuscularly according to different immunization schedules.

  • Prevnar®

    Biological/Vaccine

    Prevnar® (0.5 mL) is administered intramuscularly according to different immunization schedules.

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Experimental: Sinovac PCV24Experimental treatment 1 intervention
Group B: Active Comparator: Prevnar®Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of adverse reactions

Incidence of adverse reactions within 30 days after vaccination

Time frame
0-30 days after vaccination

Secondary outcomes

1

Incidence of adverse reactions

Incidence of adverse reactions within 7 days after vaccination

Time frame
0-7 days after vaccination
2

Incidence of serious adverse events (SAE)

Incidence of SAE during the period of safety monitoring

Time frame
from vaccination to 6 months after final dose
3

Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC)

IgG GMC 30 days after primary vaccination

Time frame
30 days after primary vaccination
4

Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI)

IgG GMI 30 days after primary vaccination

Time frame
30 days after primary vaccination

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sinovac Life Sciences Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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