Clinical trial NCT01466387: A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With MenACWY in Adults
Official title: A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningococcal Disease
Meningococcal Meningitis
Typhoid
Yellow Fever
Rabies
Japanese Encephalitis
Keywords: Adults
international travel vaccination
Meningococcal disease
meningococcal meningitis
typhoid
yellow fever
rabies
Japanese encephalitis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis Vaccines
First posted: 2011-11-08
Enrollment: 552
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study compares the safety and immunogenicity profile of several travel vaccines given alone or concomitantly with MenACWY-CRM to healthy adults.


Eligibility criteria: Inclusion Criteria:

Female and male subjects who must be healthy and must be:

1. Between 18 and 60 years of age inclusive and who have given their written informed consent;
2. Available for all visits and telephone calls scheduled for the study;
3. In good health as determined by medical history, physical examination and clinical judgment of the investigator;
4. For female subjects, having a negative urine pregnancy test.

Exclusion Criteria:

Individuals not eligible to be enrolled in the study are those:

1. who are breastfeeding;
2. who have a personal history of Neisseria meningitidis infection, typhoid fever, rabies, or any flavivirus infection (e.g., Japanese encephalitis, tick-borne encephalitis, yellow fever, dengue fever, West Nile virus infection);
3. who have been immunized with any of the study vaccines within the last five years as determined by medical history and/or vaccination card;
4. who have received investigational agents or vaccines within 30 days prior to enrollment or who expect to receive an investigational agent or vaccine prior to completion of the study;
5. who have received live licensed vaccines within 30 days and inactive vaccine within 15 days prior to enrollment or for whom receipt of a licensed vaccine is anticipated during the study period.

   (Exception: Influenza vaccine may be administered up to 15 days prior to each study immunization and no less than 15 days after each study immunization);
6. who have received an anti-malaria drug, up to 2 months prior to the study;
7. who have experienced, within the 7 days prior to enrollment, significant acute infection (for example requiring systemic antibiotic treatment or antiviral therapy) or have experienced fever (defined as body temperature ≥ 38°C) within 3 days prior to enrollment;
8. who have any serious acute, chronic or progressive disease such as:

   * history of cancer
   * complicated diabetes mellitus
   * advanced arteriosclerotic disease
   * autoimmune disease
   * HIV infection or AIDS
   * blood dyscrasias
   * congestive heart failure
   * renal failure
   * severe malnutrition (Note: Subjects with mild asthma are eligible for enrollment. Subjects with moderate or severe asthma requiring routine use of inhaled or systemic corticosteroids are not eligible for enrollment);
9. who have epilepsy, any progressive neurological disease or history of Guillain-Barre syndrome;
10. who have a history of anaphylaxis, serious vaccine reactions, or allergy to any vaccine component, including but not limited to latex allergy, egg allergy, antibiotic allergy, chicken proteins or gelatin allergy;
11. who have a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from (for example):

    * receipt of immunosuppressive therapy within 30 days prior to enrollment (systemic corticosteroids administered for more than 5 days, or in a daily dose \> 1 mg/kg/day prednisone or equivalent during any of 30 days prior to enrollment, or cancer chemotherapy);
    * receipt of immunostimulants;
    * receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 90 days prior to enrollment and for the full length of the study;
12. who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
13. who have myasthenia gravis; thyroid or thymic disorders,
14. who have any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives;
15. who are part of the study personnel or close family members of those conducting this study.
16. for whom a long-term stay (≥ 1 month) was planned in Africa, Latin America, or Asia.

Primary outcomes:
measure: Geometric Mean Anti-typhoid Vi Antibody Concentrations
timeFrame: Baseline and 1 month postvaccination (day 29).
measure: Geometric Mean Anti-Yellow Fever Antibody Titer
timeFrame: Baseline and 1 month postvaccination (day 29).
measure: Geometric Mean Anti-Japanese Encephalitis Neutralizing Antibody Titers
timeFrame: Baseline and 1 month post last vaccination (day 57).
measure: Geometric Mean Anti-Rabies Virus Neutralizing Antibody Concentration
timeFrame: Baseline and 1 month post last vaccination (day 57).
Secondary outcomes:
measure: Percentages Of Subjects With Anti-YF Neutralizing Antibody Titers ≥ 1/10, 28 Days After The Vaccination Of Typhoid Vi Polysaccharide And Yellow Fever, Concomitantly With MenACWY-CRM197 Or Given Alone
timeFrame: Baseline and 1 month postvaccination (day 29).
measure: Percentages Of Subjects With Anti-JE Neutralizing Antibody Titers ≥ 1/10, 28 Days After The Vaccination Of The Last Doses Of Japanese Encephalitis And Rabies, Given Concomitantly With MenACWY-CRM197 Or Alone
timeFrame: Baseline and 1 month post last vaccination (day 57).
measure: Percentages Of Subjects With Anti-Rabies Virus Antibody Concentrations ≥ 0.5 IU/mL 28 Days After the Vaccination Of The Last Doses Of Japanese Encephalitis And Rabies Virus, Given Concomitantly With MenACWY-CRM197 Or Alone
timeFrame: Baseline and 1 month post last vaccination (day 57).
measure: Geometric Mean hSBA Titers For Meningococcal Serogroups A,C,W,Y 28 Days After The Vaccination Of MenACWY-CRM197 Given Concomitantly With Typhoid Vi Polysaccharide And Yellow Fever Vaccines Alone
timeFrame: Baseline and 1 month postvaccination (day 29).
measure: Seroresponse Rate For Meningococcal Serogroups A,C,W,Y 28 Days After Vaccination of MenACWY-CRM197 Given Concomitantly With Typhoid Vi Polysaccharide and Yellow Fever Vaccines or Alone
timeFrame: 1 month postvaccination (day 29)
measure: Geometric Mean hSBA Titers for Meningococcal Serogroups A,C,W,Y 28 Days After the Vaccination of MenACWY-CRM197 Given Concomitantly With Japanese Encephalitis and Rabies Virus Vaccines or Alone
timeFrame: Baseline and 1 month post last vaccination (day 29 or day 57).
measure: Seroresponse Rate for Meningococcal Serogroups A,C,W,Y 28 Days After Vaccination of MenACWY-CRM197 Given Concomitantly With Japanese Encephalitis and Rabies Virus Vaccines or Alone
timeFrame: 1 month post last vaccination (day 29 or day 57)
measure: Geometric Mean Rabies Virus Neutralizing Antibody Concentration 28 Days After the Last Vaccination Of Rabies Virus Vaccine Concomitantly Either With Japanese Encephalitis or With Japanese Encephalitis And MenACWY-CRM197
timeFrame: Baseline and 1 month post last vaccination (day 57).
measure: Percentages of Subjects With Anti-rabies Virus Concentrations ≥ 0.5 IU/mL, 28 Days After the Last Vaccination of Rabies Virus Vaccine Concomitantly Either With Japanese Encephalitis or With Japanese Encephalitis and MenACWY-CRM197
timeFrame: Baseline and 1 month post last vaccination (day 57).
measure: Number of Subjects With Adverse Events of Special Interest After Any Vaccination of Japanese Encephalitis and Rabies Virus Vaccines Given Concomitantly With MenACWY-CRM197 or Alone
timeFrame: day 1 to day 57 post last vaccination
Other outcomes:
Locations:
city: Bratri Stefanu 895
country: Czech Republic
facility: Centrum ockovani a cestovni mediciny (Vaccination and Travel Medicine Centre) Poliklinika II
state: Hradec Kralove
city: Jaegerstrasse 67-69
country: Germany
facility: Berliner Centrum Fur Reise und Tropenmedizin
state: Berlin
city: Bernhard Nocht Strasse 74
country: Germany
state: Hamburg
city: Muenchen
country: Germany
facility: University of Munich Georgenstr.5
city: Rostock
country: Germany
facility: Universitat Rostock, Ernst Heydemann Str 6
Study officials:
References:
citation: Alberer M, Burchard G, Jelinek T, Reisinger E, Beran J, Hlavata LC, Forleo-Neto E, Dagnew AF, Arora AK. Safety and immunogenicity of typhoid fever and yellow fever vaccines when administered concomitantly with quadrivalent meningococcal ACWY glycoconjugate vaccine in healthy adults. J Travel Med. 2015 Jan-Feb;22(1):48-56. doi: 10.1111/jtm.12164. Epub 2014 Oct 13.
citation: Alberer M, Burchard G, Jelinek T, Reisinger E, Beran J, Meyer S, Forleo-Neto E, Gniel D, Dagnew AF, Arora AK. Co-administration of a meningococcal glycoconjugate ACWY vaccine with travel vaccines: a randomized, open-label, multi-center study. Travel Med Infect Dis. 2014 Sep-Oct;12(5):485-93. doi: 10.1016/j.tmaid.2014.04.011. Epub 2014 May 9.