Clinical trial NCT02062281: Study of Evaluating Safety and Immunogenicity of 23-Valent Pneumococcal Polysaccharide Vaccine With Influenza Vaccine in Children and Adults
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pneumococcal Infection
Influenza
Keywords: Safety
Immunogenicity
vaccine
pneumococcal
influenza
Lead sponsor: Jiangsu Province Centers for Disease Control and Prevention
Sponsor class: NETWORK
Collaborators: name: Chengdu Institute of Biological Products Co.,Ltd.
name: Shanghai Institute Of Biological Products
First posted: 2014-02-13
Enrollment: 2225
Sex: ALL
Minimum age (years): 3
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Immunogenicity of 23vPPV
timeFrame: 1 month after 23vPPV vaccination
measure: Immunogenicity of TIV
timeFrame: 1 month after TIV vaccination
Secondary outcomes:
measure: adverse events following the immunization (AEFI)
timeFrame: 28 days after 23vPPV and TIV vaccination
Other outcomes:
Locations:
city: Zhenjiang
country: China
facility: Yangzhong Center for Disease Control and Prevention
state: Jiangsu
Study officials:
affiliation: Jiangsu CDC
name: ma fubao, doctor
role: PRINCIPAL_INVESTIGATOR
References: