Phase III Clinical Trial of a Candidate PCV13 in Healthy People Aged 6 Weeks and Above (PICTPCV13i)

NCT04841369 | Completed Phase 3

• 1 other identifier: CS-CTP-PCV-III
• Study Type: interventional
• Target: 3,420
• Locations: 1 country
• Sites: 1

Brief Summary

Streptococcus pneumoniae is a major cause of morbidity and mortality in children worldwide, resulting in up to 1 million pediatric deaths every year.Since the licensure of PCV7 and PCV13,the reported overall decline in invasive pneumococcal disease in hospitalized children younger than 5 years several years is approximately 60% in Western countries.This is a single center,blind, randomized, positive-controlled clinical trial.The purpose of this study is to preliminary evaluate the safety of PCV13i vaccine in subjects at age of 7 months and above,and to investigate the safety and immunogenicity of PCV13i vaccine at age of 2 and 3 months,compared to PCV13.

Conditions

Pneumococcal Infections; Streptococcal Infections; Bacterial Infections

Keywords

PCV13; 13 valent Pneumococcal conjugate vaccine; Pneumococcal Infections; Safety; Immunogenicity

Outcome Measures

Primary Outcomes (6)

• Safety of PCV13i in preventing pneumococcal infections

  Occurance of adverse reactions in all subjects

  Within 7 days post each vaccination

• Safety of PCV13i in preventing pneumococcal infections

  Occurance of adverse reactions in all subjects

  Within 30 days post each vaccination

• Immunogenicity of PCV13i in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B)

  Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml

  30 days post three doses

• Immunogenicity of PCV13i in subjects of 7 to 11 months old (Arm 4A-4B)

  Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml

  30 days post three doses

• Immunogenicity of PCV13i in subjects of 12 months to 5 years old (Arm 5A, 5B, 6A, 6B)

  Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml

  30 days post last dose of vaccination

• Immunogenicity of PCV13i in subjects of age 50 years old and above (Arm 6A, 6B, 7A, 7B)

  Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml

  30 days post vaccination

Secondary Outcomes (9)

• Immuogenicity in terms of GMT in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B)

  30 days post three doses

• Immunogenicity in terms of IgG concentration in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B)

  30 days post three doses

• Safety of PCV13i in terms of in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B)

  6 months post one to three doses of vaccination

• Immuogenicity in terms of GMT in subjects of 7 to 11 months old (Arm 3A-3B)

  30 days post two doses

• Immuogenicity in terms of GMT in subjects of 12 months to 5 years old (Arm 4A, 4B, 5A, 5B)

  30 days post last dose of vaccination

Study Arms (9)

1A

EXPERIMENTAL

Subjects received four doses of PCV13i at 2 months of age (At least 6 weeks old)

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）

1B

ACTIVE COMPARATOR

Subjects received four doses of PCV13 at 2 months of age (At least 6 weeks old)

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

2A

EXPERIMENTAL

Subjects received four doses of PCV13i at 3 months of age

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）

3A

EXPERIMENTAL

Subject received three doses of PCV13i at 7 to 11 months of age

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）

3B

ACTIVE COMPARATOR

Subject received three doses of PCV13 at 7 to 11 months of age

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

4A

EXPERIMENTAL

Subjects received two doses of PCV13i at 12 to 23 months of age

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）

4B

ACTIVE COMPARATOR

Subjects received two doses of PCV13 at 12 to 23 months of age

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

5A

ACTIVE COMPARATOR

Subjects received one dose of PCV13i at 2 to 5 years old.

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）

5B

ACTIVE COMPARATOR

Subjects received one dose of PCV13 at 2 to 5 years old.

Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

Interventions

13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT） BIOLOGICAL

0.5mL,Intramuscular

Also known as: PCV13i

1A; 2A; 3A; 4A; 5A

13-Valent Pneumococcal Polysaccharide Conjugate Vaccine BIOLOGICAL

0.5mL,Intramuscular

Also known as: Prevnar

1B; 3B; 4B; 5B

Eligibility Criteria

• Age: 6 Weeks+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subjects of 2 months (minimum 6 weeks), 3 months , 7 months and above;
• Willing to provide proof of identity;
• Without vaccination history of pneumococcal vaccine;
• None-pregnancy or do not plan to pregnancy recently;;
• Volunteers of 18 years old and above who have the ability to understand clinical studie progress and sign informed consent;
• Volunteers of 8-17 years old and their guardians who willing sign informed consent;
• Able to understand and sign the informed consent by their guardians or trustees for the volunteers of 8 years old and below;
• Able and willing comply with the requirements of the protocol

You may not qualify if:

• Volunteers whose axillary body temperature was \>37.0# before vaccination
• Volunteers who suffered from Congenital malformation or developmental disorder, genetic defect, severe malnutrition, etc;
• Volunteers who has a history of epilepsy, convulsions or psychosis;
• Allergic person;
• Any prior administration of blood products in last 3 month;
• Any prior administration of other research medicines in last 1 month;
• Plans to participate in or is participating in any other drug clinical study;
• Any prior administration of attenuated live vaccine in last 14 days;
• Any prior administration of subunit or inactivated vaccines in last 7 days;
• Had fever before vaccination, Volunteers with temperature \>37.0°C on axillary setting;
• According to the investigator's judgement, the subjects have any other factors that make them unfit to enroll the clinical trial

Sponsors & Collaborators

• CanSino Biologics Inc.: lead
• Henan Center for Disease Control and Prevention: collaborator

Study Sites (1)

Neihuang Center for Disease Control and Prevention

Anyang, Henan, 450016, China

Location

MeSH Terms

Conditions

Pneumococcal Infections; Streptococcal Infections; Bacterial Infections

Interventions

Heptavalent Pneumococcal Conjugate Vaccine

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Pneumococcal Vaccines; Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined

Study Officials

• Shengli Xia

  Henan Province Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 12, 2021
• Study Start: April 13, 2021
• Primary Completion: March 30, 2022
• Study Completion: September 20, 2022
• Last Updated: April 2, 2024

Record last verified: 2022-10

Locations

CN (1)