Haemophilus influenzae type b infection prophylaxis
Conditions
Interventions
Group I (Experimental): alum phosphate adjuvanted Quimi-Hib, 10µg, intramuscular route, 6-10-14 weeks schedule Group II (Control): Quimi-Hib, 10µg, intramuscular route, 6-10-14 weeks schedule
Sponsors
Center for Genetic Engineering and Biotechnology
Ministry of Public Health, CUBA
Eligibility
Sex/Gender
All
Age
No minimum to 7 Weeks
Inclusion criteria
Inclusion criteria: 1.Signing of the written inform consent Act by parents/legal guardians. 2.6 weeks old healthy infants, both sexes, with normal clinical examination and medical history. 3.Nutritional evaluation over 10 percentile 4.History of no primary immunization series against Hib or DTP. 5.Administration of the scheduled Hepatitis B vaccine dose at birth
Exclusion criteria
Exclusion criteria: 1.Administration of other Investigation Medicinal Product (IMP) different to IMP under study in the 30 days previous to administration of the 1st vaccine dose or its intention of use during the period planned for the clinical trial. 2.Acute infectious illness or body temperature over 37?C at the moment of vaccination visit. 3.History of preterm delivery (birth before 36th weeks of pregnancy). 4.Major congenital defects or serious chronic disease. 5.Infants with history of convulsive or non-convulsive encephalopathy. 6.Chronic medication (defined as more than 21 days of treatment) with immune-suppressor or immuno-modulatory drugs prior to administration of the 1st vaccine dose. 7.History of invasive Hib disease. 8.Any suspected or diagnosed immune-suppression or immunodeficiency (congenital o secondary), including HIV infection, based on the medical history and physical examination. 9.History of allergic reactions or allergic disease with probability to be exacerbated by any component of the vaccine under study (including thiomersal allergy). 10.Gammaglobulin administration or other blood –derived components during the period prior to administration of the 1st vaccine dose or the intention of administration during the planned trial period. 11.Maternal history for HIV or HBV infection, based on the medical records.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IgG antiPRP GMT, Short-term (=0,15 mcg/mL) and long-term (=1 mcg/mL) seroprotection percentages, seroconversion rate (increase in =2 folds in baseline IgG antiPRP antibody titer measured at day 30 after administration of the last vaccine dose). | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of local and systemic adverse events Evaluation times: 1h, 24h, 48h, 72h, Days 7 and 30 post-vaccination in each dose. -Occurrence of the Adverse Event (AE) -Description of the AE (name of the AE) -Duration of the AE (difference between start date and stop date) -Intensity of the AE (Mild, Moderate, Severe) -Seriousness of the AE (Serious, no serious) -Action taken with study drug (None, Dose reduced, Dose temporarily reduced, Discontinued ) -Outcomes (Recovered, improved, persisting or recovered with sequels) -Causality (1.Very likely, 2.Probable, 3.Possible, 4. Not Probable, 5. Non-related, 6. Not evaluable) | — |
Countries
Cuba
Contacts
Public ContactDr. Arístides Betancourt
Center for Genetic Engineering and Biotechnology
Outcome results
None listed