Quimi-Hib® and Quimi-Hib(AlPO4) vaccines in an accelerated 6-10-14 weeks primary vaccination series

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000135
• Date of registration: 12/09/2012
• Primary sponsor: Center for Genetic Engineering and Biotechnology
• Public title: Quimi-Hib® and Quimi-Hib(AlPO4) vaccines in an accelerated 6-10-14 weeks primary vaccination series
• Scientific title: “Immunogenicity, tolerance and reactogenicity of Quimi-Hib and alum phospate adjuvanted Quimi-Hib vaccines in healthy infants according to 6 – 10 – 14 weeks primary vaccination series. A multicenter, controlled, randomized, doubled blind clinical trial.”
• Date of first enrolment: 27/10/2012
• Target sample size: 208
• Recruitment status: Pending
• URL: http://registroclinico.sld.cu/trials/RPCEC00000135-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Double Blind Placebo: Active Assignment: Parallel Purpose: Prevention

Countries of recruitment

Cuba

Contacts

• Name: Dr. Aristides Betancourt
• Affiliation: Center for Genetic Engineering and Biotechnology, CIGB

• Name: Dr. Arístides Betancourt
• Affiliation: Center for Genetic Engineering and Biotechnology

Key inclusion & exclusion 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: 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.

Age minimum: aged 6 weeks
Age maximum: 7 weeks
Gender: Both

Health Condition(s) or Problem(s) studied

Haemophilus influenzae type b infection prophylaxis

Intervention(s)

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

Primary Outcome(s)

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 Outcome(s)

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)

Secondary ID(s)

IG/QHI/SE/1001

Source(s) of Monetary Support

HeberBiotec S.A.

Secondary Sponsor(s)

Ministry of Public Health, CUBA