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

NCT02062281 | Completed Phase 4 DMC

• 1 other identifier: JSEPI-002
• Study Type: interventional
• Target: 2,225
• Locations: 1 country
• Sites: 1

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

Keywords

Safety; Immunogenicity; vaccine; pneumococcal; influenza

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (1)

• adverse events following the immunization (AEFI)

  28 days after 23vPPV and TIV vaccination

Study Arms (3)

23-valent Pneumococcal Polysaccharide vaccine

ACTIVE COMPARATOR

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

Trivalent Influenza Vaccine

ACTIVE COMPARATOR

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

23vPPV+TIV

EXPERIMENTAL

Biological: 23vPPV+TIV

Interventions

23-valent pneumococcal polysaccharide vaccine BIOLOGICAL

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

23-valent Pneumococcal Polysaccharide vaccine

trivalent influenza vaccine BIOLOGICAL

Single 0.5ml trivalent influenza vaccine was administered IM

Trivalent Influenza Vaccine

23vPPV+TIV 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.

23vPPV+TIV

Eligibility Criteria

• Age: 3 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Generally healthy male or female, for adults 50-65 years of age, for children 3-7 years of age.
• Available for the duration of the trial - approximately 2 months.
• No history of severe adverse reaction associated with a vaccine.

You may not qualify if:

• 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.
• Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain.
• Autoimmune disease or immunodeficiency.
• 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.
• 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.
• Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years.
• 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.
• 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)
• History of any blood products or seasonal influenza vaccine administration within 3 months before the dosing.
• Administration of any other investigational research agents within 30 days before the dosing.
• 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.
• Axillary temperature \> 37.0 centigrade at the time of dosing.
• Psychiatric condition that precludes compliance with the protocol.
• 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

Sponsors & Collaborators

• Jiangsu Province Centers for Disease Control and Prevention: lead
• Chengdu Institute of Biological Products Co.,Ltd.: collaborator
• Shanghai Institute Of Biological Products: collaborator

Study Sites (1)

Yangzhong Center for Disease Control and Prevention

Zhenjiang, Jiangsu, 212200, China

Location

MeSH Terms

Conditions

Pneumococcal Infections; Influenza, Human

Interventions

23-valent pneumococcal capsular polysaccharide vaccine; Influenza Vaccines

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• ma fubao, doctor

  Jiangsu CDC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2014
• First Posted: February 13, 2014
• Study Start: November 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: February 13, 2014

Record last verified: 2014-02

Locations

CN (1)