Immunogenicity and safety of a new meningococcal A conjugate vaccine in Indian children aged 2-10 years: A Phase II/III double-blind randomized controlled trial

Vaccine

Volumn 30, Issue 45, 2012, Pages 6456-6460

  Hirve, Siddhivinayak ^a   Bavdekar, Ashish ^a   Pandit, Anand ^a   Juvekar, Sanjay ^a   Patil, Malini ^a   Preziosi, Marie Pierre ^b   Tang, Yuxiao ^c   Marchetti, Elisa ^c   Martellet, Lionel ^c   Findlow, Helen ^d   Elie, Cheryl ^e   Parulekar, Varsha ^f   Plikaytis, Brian ^e   Borrow, Ray ^d   Carlone, George ^e   Kulkarni, Prasad S ^g   Goel, Akshay ^g   Suresh, Karupothula ^g   Beri, Suresh ^g   Kapre, Subhash ^g   Jadhav, Suresh ^g   Preaud, Jean Marie ^c   Viviani, Simonetta ^c   LaForcec, Marc ^c   more..

^a KEM HOSPITAL   (India)

^b WORLD HEALTH ORGANIZATION   (Switzerland)

^c PATH   (France)

^d PUBLIC HEALTH ENGLAND   (United Kingdom)

^e CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

^f DiagnoSearch Life Sciences   (India)

^g Serum Institute of India Ltd   (India)

Author keywords

Conjugate vaccine; Immunogenicity; Meningococcus; Safety; Serogroup A

Indexed keywords

IMMUNOGLOBULIN G; MENINGOCOCCUS VACCINE;

ANOREXIA; ANTIBODY TITER; ARTICLE; BRONCHOPNEUMONIA; CHILD; COMMON COLD; COMPARATIVE STUDY; CONTROLLED STUDY; COUGHING; DOUBLE BLIND PROCEDURE; DRUG FATALITY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HUMAN; HUMAN EXPERIMENT; IMMUNE RESPONSE; IMMUNIZATION; IMMUNOGENICITY; INDIA; INJECTION SITE REACTION; IRRITABILITY; MALE; NORMAL HUMAN; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT INFECTION; SIDE EFFECT; SYNCOPE; TONSILLITIS; VACCINATION;

ANTIBODIES, BACTERIAL; CHILD; CHILD, PRESCHOOL; DOUBLE-BLIND METHOD; FEMALE; HUMANS; IMMUNOGLOBULIN G; INDIA; MALE; MENINGITIS, MENINGOCOCCAL; MENINGOCOCCAL VACCINES; POLYSACCHARIDES, BACTERIAL; SERUM BACTERICIDAL ANTIBODY ASSAY; VACCINES, CONJUGATE;

EID: 84866487460     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2012.08.004     Document Type: Article

References (16)

1. LaForce F.M., Ravenscroft N., Djingarey M., Viviani S. Epidemic meningitis due to group A Neisseria meningitidis in the African meningitis belt: a persistent problem with an imminent solution. Vaccine 2009, 27S:B13-B19.
2. Lapeyssonnie L. La meningite cerebrospinale en Afrique. Bull World Health Organ 1963, 28:1-114.
3. Mueller J.E., Borrow R., Gessner B.D. Meningococcal serogroup W135 in the African meningitis belt: epidemiology, immunity and vaccines. Expert Rev Vaccines 2006, 5(3):319-336.
4. Sinclair D., Preziosi M.P., John T.J., Greenwood B. The epidemiology of meningococcal disease in India. Trop Med Int Health 2010, 15:1421-1435.
5. Adegbola R.A., Secka O., Lahai G., Lloyd-Evans N., Njie A., Oluwalana C., et al. Elimination of Haemophilus influenzae type b (Hib) disease from Tha Gambia after the introduction of routine immunisation with a Hib conjugate vaccine: a prospective study. Lancet 2005, 366(9480):144-150.
6. Trotter C.L., Andrews N.J., Kaczmarski E.B., Miller E., Ransay M.E. Effectiveness of meningococcal serogroup C conjugate vaccine 4 years after introduction. Lancet 2004, 364(9431):365-367.
7. CDC Updated recommendations for use of meningococcal conjugate vaccines - Advisory Committee on Immunization Practices (ACIP). MMWR 2011, 60(3):72-76.
8. LaForce F.M., Konde K., Viviani S., Preziosi M.P. The Meningitis Vaccine Project. Vaccine 2007, 25(Suppl. 1):A97-A100.
9. Frasch C.E., Preziosi M.P., LaForce F.M. Development of a group A meningococcal conjugate vaccine, MenAfriVac™. Hum Vaccines Immunother 2012, 8(6):1-10.
10. Borrow R., Balmer P., Miller E. Meningococcal surrogates of protection - serum bactericidal antibody activity. Vaccine 2005, 23:2222-2227.
11. Maslanka S.E., Gheesling L.L., Libutti D.E., Donaldson K.B., Harakeh H.S., Dykes J.K., et al. Standardization and a multilaboratory comparison of Neisseria meningitidis serogroup A and C serum bactericidal assays. The Multilaboratory Study Group. Clin Diagn Lab Immunol 1997, 4(2):156-167.
12. Carlone G.M., Frasch C.E., Siber G.R., Quataert S., Gheesling L.L., Turner S.H., et al. Multicenter comparison of levels of antibody to the Neisseria meningitidis group A capsular polysaccharide measured by using an enzyme-linked immunosorbent assay. J Clin Microbiol 1992, 30(1):154-159.
13. Farrington C.P., Manning G. Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference or non-unity relative risk. Stat Med 1990, 9(12):1447-1454.
14. Miettinen O., Nurminen M. Comparative analysis of two rates. Stat Med 1985, 4(2):213-226.
15. "EMEA. Points to consider on switching between superiority and non-inferiority. London, 27 July 2000. CPMP/EWP/482/99." http://www.ema.europa.eu/pdfs/human/ewp/048299en.pdf.
16. Sow S., Okoko J.B., Diallo A., Viviani S., Borrow R., Carlone G., et al. Immunogenicity and safety of a meningococcal A conjugate vaccine in Africans. N Engl J Med 2011, 364:2293-2304.