Study of Evaluating Safety and Immunogenicity of 23-Valent Pneumococcal Polysaccharide Vaccine With Influenza Vaccine in Children and Adults

NCT ID: NCT02062281

Last Updated: 2014-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 2225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-01-31

Brief Summary

The 23-valent pneumococcal Polysaccharide vaccine (23vPPV) has been developed for children and adults to prevent pneumococcal diseases such as pneumonia (inflammation of the lungs), meningitis (inflammation of the brain lining), and septicemia (blood poisoning) since 2006 in China. Also, the trivalent influenza vaccine (TIV) is frequently administered to the children and adults. The main objective of this study is to show that both vaccines can safely be administered together without affecting the immune response of protecting against disease.

Conditions

Pneumococcal Infection; Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

23-valent Pneumococcal Polysaccharide vaccine

0.5ml 23-valent pneumococcal Polysaccharide vaccine made by Chengdu Institute of Biological Products Co.,Ltd.

lot number: 20130106-1, duration:JAN,17,2015.

Group Type: ACTIVE_COMPARATOR

23-valent pneumococcal polysaccharide vaccine

Intervention Type: BIOLOGICAL

Single 0.5ml 23-valent pneumococcal polysaccharide vaccine was administered intramuscularly (IM)

Trivalent Influenza Vaccine

0.5ml trivalent influenza vaccine made by Shanghai Institute of Biological Products Co.,Ltd.

lot number:20130713, duration:Jul,1,2014.

Group Type: ACTIVE_COMPARATOR

trivalent influenza vaccine

Intervention Type: BIOLOGICAL

Single 0.5ml trivalent influenza vaccine was administered IM

23vPPV+TIV

Group Type: EXPERIMENTAL

23vPPV+TIV

Intervention Type: BIOLOGICAL

Single 0.5 ml 23-valent pneumococcal polysaccharide vaccine (23vPPV) and a single 0.5 ml trivalent inactivated influenza vaccine (TIV) were administered IM, in one day.

Interventions

23-valent pneumococcal polysaccharide vaccine

Single 0.5ml 23-valent pneumococcal polysaccharide vaccine was administered intramuscularly (IM)

Intervention Type: BIOLOGICAL

trivalent influenza vaccine

Single 0.5ml trivalent influenza vaccine was administered IM

Intervention Type: BIOLOGICAL

23vPPV+TIV

Single 0.5 ml 23-valent pneumococcal polysaccharide vaccine (23vPPV) and a single 0.5 ml trivalent inactivated influenza vaccine (TIV) were administered IM, in one day.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Generally healthy male or female, for adults 50-65 years of age, for children 3-7 years of age.

2. Available for the duration of the trial - approximately 2 months.

3. No history of severe adverse reaction associated with a vaccine.

Exclusion Criteria

1. Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine, such as egg, egg protein, etc.

2. Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain.

3. Autoimmune disease or immunodeficiency.

4. Asthma that is unstable or required emergent care, hospitalization or intubation during the past two years or that required the use of oral or intravenous corticosteroids.

5. Diabetes mellitus (type I or II), with the exception of gestational diabetes History of thyroidectomy or thyroid disease that required medication within the past 12 months.

6. Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years.

7. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws.

8. Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis)

9. History of any blood products or seasonal influenza vaccine administration within 3 months before the dosing.

10. Administration of any other investigational research agents within 30 days before the dosing.

11. Administration of any live attenuated vaccine within 30 days before the dosing Administration of subunit or inactivated vaccines, e.g., pneumococcal vaccine, or allergy treatment with antigen injections, within 14 days before the dosing.

12. Axillary temperature > 37.0 centigrade at the time of dosing.

13. Psychiatric condition that precludes compliance with the protocol.

14. Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chengdu Institute of Biological Products Co.,Ltd.

INDUSTRY

Sponsor Role: collaborator

Shanghai Institute Of Biological Products

INDUSTRY

Sponsor Role: collaborator

Jiangsu Province Centers for Disease Control and Prevention

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ma fubao, doctor

Role: PRINCIPAL_INVESTIGATOR

Jiangsu CDC

Locations

Yangzhong Center for Disease Control and Prevention

Zhenjiang, Jiangsu, China

Countries

China

Other Identifiers

JSEPI-002

Identifier Type: -

Identifier Source: org_study_id