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

Influenza Clinical Trial

Official title:

A Phase 4, Randomized, Single-blind Trial to Evaluate Safety and Immunogenicity of a 23-Valent Pneumococcal Polysaccharide Vaccine When Administered Simultaneously With Trivalent Inactivated Influenza Vaccine in Healthy Children Aged 3-7years and Healthy Adults 65 Aged 50-65years.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02062281
• Other study ID #: JSEPI-002
• Status: Completed
• Phase: Phase 4
• First received: February 12, 2014
• Last updated: February 12, 2014
• Start date: November 2013
• Est. completion date: January 2014

Study information

• Verified date: February 2014
• Source: Jiangsu Province Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2225
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human
• Pneumococcal Infection
• Pneumococcal Infections

Intervention

Biological:
• 23-valent pneumococcal polysaccharide vaccine
Single 0.5ml 23-valent pneumococcal polysaccharide vaccine was administered intramuscularly (IM)
• trivalent influenza vaccine
Single 0.5ml trivalent influenza vaccine was administered IM
• 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.

Locations

Country	Name	City	State
China	Yangzhong Center for Disease Control and Prevention	Zhenjiang	Jiangsu

Sponsors (3)

Lead Sponsor	Collaborator
Jiangsu Province Centers for Disease Control and Prevention	Chengdu Institute of Biological Products Co.,Ltd., Shanghai Institute Of Biological Products

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity of 23vPPV	IgG GMC measured by enzyme-linked immunosorbent assay (ELISA) and expressed in micrograms per mL (mcg/mL) for serotypes 1,2,5,6B,14,19F,23F,which were frequently detected in patients in Chinese.	1 month after 23vPPV vaccination	No
Primary	Immunogenicity of TIV	Percentage of participants achieving at Least a 4-fold Increase in the Titer of the Standard Hemagglutination Inhibition Assay (HAI)	1 month after TIV vaccination	No
Secondary	adverse events following the immunization (AEFI)		28 days after 23vPPV and TIV vaccination	Yes