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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02062281
Recruitment Status : Completed
First Posted : February 13, 2014
Last Update Posted : February 13, 2014
Chengdu Institute of Biological Products Co.,Ltd.
Shanghai Institute Of Biological Products
Information provided by (Responsible Party):
Jiangsu Province Centers for Disease Control and 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.

Condition or disease Intervention/treatment Phase
Pneumococcal Infection Influenza Biological: 23-valent pneumococcal polysaccharide vaccine Biological: trivalent influenza vaccine Biological: 23vPPV+TIV Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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 Start Date : November 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : January 2014

Arm Intervention/treatment
Active Comparator: 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.

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

Active Comparator: Trivalent Influenza Vaccine

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

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

Biological: trivalent influenza vaccine
Single 0.5ml trivalent influenza vaccine was administered IM

Experimental: 23vPPV+TIV 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.

Primary Outcome Measures :
  1. Immunogenicity of 23vPPV [ Time Frame: 1 month after 23vPPV vaccination ]
    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.

  2. Immunogenicity of TIV [ Time Frame: 1 month after TIV vaccination ]
    Percentage of participants achieving at Least a 4-fold Increase in the Titer of the Standard Hemagglutination Inhibition Assay (HAI)

Secondary Outcome Measures :
  1. adverse events following the immunization (AEFI) [ Time Frame: 28 days after 23vPPV and TIV vaccination ]

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02062281

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China, Jiangsu
Yangzhong Center for Disease Control and Prevention
Zhenjiang, Jiangsu, China, 212200
Sponsors and Collaborators
Jiangsu Province Centers for Disease Control and Prevention
Chengdu Institute of Biological Products Co.,Ltd.
Shanghai Institute Of Biological Products
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Principal Investigator: ma fubao, doctor Jiangsu CDC

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Responsible Party: Jiangsu Province Centers for Disease Control and Prevention Identifier: NCT02062281     History of Changes
Other Study ID Numbers: JSEPI-002
First Posted: February 13, 2014    Key Record Dates
Last Update Posted: February 13, 2014
Last Verified: February 2014
Keywords provided by Jiangsu Province Centers for Disease Control and Prevention:
Additional relevant MeSH terms:
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Pneumococcal Infections
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs