A phase II, double-blind, randomised, controlled, dose ranging study to evaluate the safety, immunogenicity, dose response and schedule response of a meningococcal A conjugate vaccine administered concomitantly with local expanded program on immunisation (EPI) vaccines in healthy infants

Phase 2

Completed

• Conditions: Bacterial meningitis; Nervous System Diseases

• Registration Number: ISRCTN82484612
• Lead Sponsor: Serum Institute of India Limited

Brief Summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26553690 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26553685 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26553670 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26553669

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-08-06
• Study Completion: 2012-12-31
• Last Update Posted: 25 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

1. Aged 14 to 18 weeks old
2. Free of obvious health problems as established by medical history including physical examination and clinical judgment of the investigator
3. Guardian capable and willing to bring their child or to receive home visits for their child for all follow-up visits
4. Residence in the study area
5. Fully vaccinated according to the local EPI schedule (Bacillus Calmette-Guerin [BCG] and OPV at birth, two doses of diphtheria, tetanus, whole cell pertussis, haemophilus influenzae type B and hepatitis B virus [DTwPHibHBV] and OPV at 6 and 10 weeks of age)

Exclusion Criteria

1. Previous vaccination against serogroup A Neisseria meningitidis
2. Known exposure to serogroup A N. meningitidis since birth
3. History of allergic disease or known hypersensitivity to any component of the study vaccines
4. History of serious adverse reactions following administration of vaccines included in the local program of immunisation
5. Administration of any vaccine other than EPI vaccines within 30 days prior to administration of study vaccines or planned vaccination during the first four weeks after the study vaccination
6. Use of any investigational or non-registered drug since birth
7. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period
8. Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying agents since birth (including systemic or inhaled corticosteroids, this means prednisone, or equivalent, greater than 0.5 mg/kg/day; topical steroids are allowed)
9. A family history of congenital or hereditary immunodeficiency
10. History of meningitis or seizures or any neurological disorder
11. Major congenital defects or serious chronic illness, including malnutrition (as per investigator's judgment). Minimum weight should be of 4 kg at the time of enrolment in the study (at 14 - 18 weeks of age).
12. Acute disease at the time of enrolment (acute disease is defined as the presence of a moderate or severe illness with or without fever) is a temporary exclusion
13. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by medical history, physical examination or laboratory tests, which in the opinion of the investigator, might interfere with the study objectives
14. Any condition or criteria that in the opinion of the investigator might compromise the well being of the subject or the compliance with study procedures or interfere with the outcome of the study
15. Non-residence in the study area or intent to move out within 2 years

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> To compare the immunogenicity at 28 days after vaccination of range dosages of the PsA-TT vaccine, when administered to infants in a two-dose schedule at 14 weeks and 9 months of age concomitantly with EPI vaccines.<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Safety of range dosages of the PsA-TT vaccine, when administered to healthy infants in a two-dose schedule at 14 weeks and 9 months of age concomitantly with EPI vaccines (i.e. diphtheria, tetanus, whole cell pertussis, hepatitis B, Hib, and oral poliomyelitis at 14 weeks; measles and yellow fever at 9 months)<br> 2. Immunogenicity of the EPI vaccines in all vaccines groups, when administered alone or concomitantly with the PsA-TT vaccine at 14 weeks, 9 months, and 12 months of age<br> 3. Immunogenicity at 28 days, at 12 and 24 months (i.e. at 24 and 36 months of age) after a single dose of the PsA-TT vaccine administered at 12 months of age concomitantly with EPI vaccines<br>